P 201 - Società Italiana di Urologia

Transcript

Cari amici e soci SIU,
in questo volume abbiamo riunito tutti i contributi scientifici presentati all’87° Congresso Nazionale della
Società Italiana di Urologia che quest’anno si svolge a Firenze.
Siamo certi che questa raccolta vi aiuterà a seguire con metodo i lavori congressuali facilitando la vostra
partecipazione nelle discussioni delle varie sessioni e vi rimarrà anche quale prezioso ricordo di questo
evento.
Un ringraziamento particolare va ai Colleghi che hanno svolto il compito di revisori. Dei 546 contributi
inviati sono stati selezionati 299 poster e 47 video, con un tasso di accettazione del 63%. Gli argomenti
che hanno suscitato maggiore interesse sono stati l’oncologia di prostata, vescica e rene, e le tecniche
chirurgiche mini-invasive.
Ogni contributo scientifico è stato valutato da tre esperti secondo i criteri dell’appropriatezza metodologica,
della rilevanza dei risultati e della qualità della stesura. Nel caso dei video i parametri di revisione sono
stati l’innovazione e la riproducibilità della tecnica, la metodologia di condotta dell’intervento e la qualità
complessiva del filmato.
Anche quest’anno numerosi contributi ricevuti sono stati realizzati in lingua inglese, confermando il
notevole successo di questa iniziativa avviata nel 2010. Per tale motivo, 10 delle 32 sessioni scientifiche
si svolgeranno in lingua inglese con la presenza, tra i moderatori, degli ospiti stranieri del congresso. Per
ragioni organizzative di raggruppamento dei contributi in sessioni con argomenti omogenei, non è stato
possibile soddisfare tutte le richieste di presentazione in inglese pervenuteci. Ci scusiamo di questo con
tutti gli Autori interessati.
Il vero successo del Congresso dipende, comunque, da tutti voi, dalla vostra attiva partecipazione, dal
vostro entusiasmo e, perché no, anche dalle vostre critiche.
Con l’auspicio che questo Congresso possa soddisfare pienamente le vostre aspettative, vi auguriamo una
buona lettura di questa raccolta di abstract.
Carlo Terrone
COMITATO SCIENTIFICO SIU
CARLO TERRONE
Coordinatore
ALBERTO BRIGANTI
GIANLUCA GIANNARINI
ANDREA MINERVINI
GIACOMO NOVARA
GIUSEPPE MARTORANA
GIUSEPPE MORGIA
Il Comitato è coadiuvato nelle sue attività da:
Barbara Fiorani, Capo Segreteria - SIU Executive Manager
[email protected]
Carla Ceniccola, Amministrazione - Segreteria Scientifica
[email protected] - [email protected]
Davide Frasca, Web e Comunicazione Grafica
[email protected]
Ilaria Giamminonni
[email protected]
POSTER
La responsabilità del contenuto
degli Abstract è interamente
ascrivibile agli Autori
P1
CONTINENCE OUTCOMES ROBOTIC ASSISTED RADICAL PROSTATECTOMY IN SUBOPTIMAL PATIENTS
B. Rocco, E. De Lorenzis, S. Samavedi, K. Palmer, H. Abdul Muhsin, S. Pigilam, V. Patel (Milano)
Aim of the study
Large prostate, elderly age, higher BMI, salvage prostatectomy and TURP have been associated with poorer continence outcomes
during prostatectomy. We analyze the continence outcomes of robotic assisted prostatectomy in this particular subset of patients.
Materials and methods
From January 2008 through November 2012, 4023 patients underwent RARP by a single surgeon (VP) at our institution.
Retrospective analysis of prospectively collected data from our Institutional Review Board approved registry identified 3362 men
who had one year of follow-up. This cohort of patients was stratified into six groups: Group I- age 70 and over (n=451); Group
II-body mass index (BMI) 35 and over (n=197); Group III- prior bladder neck procedures (n=103); Group IV-prostate weight 80
g and over (n=280); and Group V- salvage prostatectomy patients (n=41). Group VI contained patients (n=2447) with none of
these risk factors. Continence was defined as the use of no pads at follow-up. Follow-up was completed at 6 weeks, 3-, 6-, 9- and
12-months. Continence outcomes at follow-up were analyzed for all groups. Mean time to continence was compared among the
groups using ANOVA and the Tukey-Kramer test to conduct multiple group comparisons.
Results
he continence rate for patients 70 and over was 88.9% (401/451) and the mean time 3.2 ± 4.5 months; BMI 35 and over was
96.5% (190/197) 3.1 ± 4.5 months; prior bladder neck treatment 87.4% (90/103) 3.4 ± 4.7 months; prostate weight 80 g and
over 89.3% (250/280) 3.3 ± 4.4 months; and salvage procedures 56.1% (23/41) 6.6 ± 8.3 months (p=0.015). Multiple group
comparisons of mean time to continence between each group and the salvage group revealed significant differences (p=0.031).
The time to continence was similar for Groups I, II, III, and IV. The continence rate for Group VI (non-risk patients) was 95.1%
(2326/2447) and the mean time to continence was 2.4 ± 3.2 months. A comparison of the mean time to continence for all groups
in the study (Groups I-VI) revealed a significance difference (p<0.001).
Discussion
This study has demonstrated that selected risk factors including older age (70 and over), BMI 35 and over, prior bladder neck
treatment, prostate weight 80 g and over, and previously having undergone a salvage procedure adversely affect the return of
continence following RARP. Patients with these risk factors should be counseled concerning expectations for achieving urinary
continence. Patients with none of the risk factors assessed in the present study have an increased probability of achieving
continence early on following RARP
Conclusions
Suboptimal patients should be counseled concerning expectations for achieving urinary continence. Patients with none of the risk
factors assessed in the present study have an increased probability of achieving continence early on following RARP
1
P2
P3
DETRUSOR HYPOCONTRACTILITY AFTER OPEN RETROGRADE, ANTEGRADE AND ROBOT-ASSISTED
RADICAL PROSTATECTOMY: FUNCTIONAL AND URODYNAMIC PRELIMINARY DATA
HOW TO OPTIMIZE THE USE OF ROBOTIC ASSISTED RADICAL PROSTATECTOMY: THE ROLE OF
PREOPERATIVE PATIENT CHARACTERISTICS TO IDENTIFY IDEAL CANDIDATES FOR MINIMALLY
INVASIVE APPROACH
G. Pizzirusso, F. Lanzi, F. Scipioni, F. Cecconi, F. Gentile, N. Tosi, A. Canale, G. De Rubertis, G. Barbanti (Siena)
Scopo del lavoro
The aim of the study is to evaluate functionally and urodynamicly the newly-onset of detrusor hypocontractility in patients
undergone radical prostatectomy through different approaches
Materiali e metodi
We evaluated 59 consecutive patients (pts) undergone open retrograde (ORP), 64 open antegrade (OAP) and 52 robot-assisted
radical prostatectomy (RRP) for clinically localized prostate cancer.. Functional follow-up included the administration of ICIQ-SF
questionnaire at months 1,3,6 and 12 and uroflowmetry at the 6th month postoperative. In case of non pathological flow and post
micturition residual (PMR)≥30cc in pts without preoperative PMR we performed urodynamic evaluation
Risultati
Data resulted complete for 53 pts undergone ORP, 61 to OAP and 52 to RRP. Mean follow-up was (range) 23.7(13-49) months.
Overall, 88.5% of ORP, 89.2 of OAP and 90.5% of RRP Group pts fulfilled our continence criteria (≤1pad and ICIQ-SF≤2)
at a minimum follow-up of 12months. In ORP Group 11/24(45.8%) pts without preoperative PMR developed a postoperative
PMR≥30cc, 12/27(44.4%) of OAP and 8/32(25%) of RRP. These pts were further investigated through urodynamic study. In ORP
Group we identified a true newly-onset PMR significantly linked to a detrusor hypocontractility in 8/11(72.7%) pts: mean Qmax,
PDet and PMR of pts with true PMR were (range) 11.8(5.9-14.5)mL/s, 31.7(18.1-45.1)cmH2O and 42(32-56)cc Vs 13.2(8.2-16.2)
mL/s, 33.7(20.6-47.2)mmH2O and PMR
Discussione
A newly-onset post micturition residual in patients undergone radical prostatectomy may be due to a detrusor hypocontractility; its
various prevalence among the surgical techniques may be referred to different nervous fibers of hypogastric plexus stress during
isolation of seminal vesicles: thus, bladder mobilization and traction results greater during open retrograde than open antegrade
and robot-assisted prostatectomy in which bladder manipulation is usually limited to the neck region
Conclusioni
Postoperative post micturition residual may be considered as a signal of detrusor hypocontractility due to tensile stress of nervous
fibers of hypogastric plexus during isolation of seminal vesicles. Its prevalence resulted lower in robotic prostatectomy
2
A. Briganti, G. Gandaglia, A. Gallina, P. Dell’Oglio, A. Nini, N. Buffi, A. Larcher, E. Zaffuto, V. Mirone, R. Damiano, F.
Cantiello, G. Guazzoni, F. Montorsi (Milano)
Aim of the study
Robotic-assisted radical prostatectomy (RARP) may be associated with increasing costs for national health cares. We
hypothesized that not all patients benefit at the same extent from minimally invasive surgery in terms of post-operative outcomes.
The study included 609 patients with PCa treated with RARP or ORP between 2007 and 2013 at a single tertiary center by a
single surgeon. All patients had complete preoperative available data, including age at surgery, body mass index (BMI), CCI, and
preoperative erectile function (EF). The International Index of Erectile Function-Erectile Function Index (IIEF-EF) was used to
evaluate EF after BNSRP. Postoperative EF recovery was defined as an IIEF-EF domain score ≥22. Postoperative UC was defined
as being completely pad-free over a 24-hour period. Patients were stratified according to their probability of postoperative erectile
dysfunction: low (age≤65, IIEF-EF≥26, CCI≤1), intermediate (age 66-69 or IIEF-EF 11-25, CCI≤1), and high-risk (age≥70 or
IIEF-EF≤10 or CCI≥2). Additionally, we stratified patients according to their risk of urinary incontinence: very low (IIEF-EF>10,
age10, age10 and age ≥ 65 years), and high-risk (IIEF-EF 1-10) based on previously published classification tools. The KaplanMeier method was used to test the impact of the surgical approach (RARP vs. ORP) on EF and UC recovery after stratifying
patients according to the risk group.
Results
At a mean follow up of 32.5 months (median 28), patients treated with RARP had higher EF (52.1 vs. 67.8%; P
Discussion
RARP leads to higher UC and EF recovery rates compared to ORP. However, not all patients benefit from the minimally invasive
approach at the same extent. In patients with the worse preoperative characteristics (i.e., older and sicker patients), RARP is not
associated with better functional outcomes compared to ORP.
Conclusions
Our findings indicate that, in order to allow a more rationale resource utilization, patient selection is crucial for the identification
of the best candidate for RARP.
3
P4
P5
IMPACT OF MINIMALLY INVASIVE APPROACH ON THE PROBABILITY OF EARLY COMPLETE FUNCTIONAL
RECOVERY AFTER BILATERAL NERVE SPARING RADICAL PROSTATECTOMY.
IMPACT OF SURGICAL TECHNIQUE ON THE RISK OF BIOCHEMICAL RECURRENCE IN PATIENTS WITH
INTERMEDIATE AND HIGH-RISK PROSTATE CANCER TREATED WITH RADICAL PROSTATECTOMY
L. Villa, P. Dell’Oglio, N. Suardi, A. Gallina, A. Russo, A. Nini, M. Lazzeri, N. Buffi, G. Lughezzani, A. Larcher, G. Guazzoni, F.
Montorsi, A. Briganti (Milano)
V. Cucchiara, G. Gandaglia, P. Dell’Oglio, A. Nini, G. Lista, A. Salonia, U. Capitanio, E. Di Trapani, A. Russo, F. Montorsi, A.
Briganti (Milano)
Aim of the study
We investigated whether surgical approach affects both early post-operative urinary continence (UC) and erectile function (EF)
recovery
Aim of the study
In the lack of prospective randomized trials evaluating the comparative effectiveness of robot-assisted (RARP) and open radical
prostatectomy (ORP), the oncological safety of the minimally invasive approach in patients with more aggressive disease is still
debated. We aimed at comparing the biochemical recurrence (BCR) rates of RARP and ORP in patients with intermediate or highrisk prostate cancer (PCa). Additionally, since individuals experiencing early BCR are at increased risk of clinical progression and
cancer-specific mortality, we assessed the impact of the surgical approach also on the risk of early BCR.
The study included 1798 patients affected by prostate cancer treated with bilateral nerve-sparing radical prostatectomy between
1993 and 2013 at a single tertiary referral center. Pre and post-operative EF was assessed by the International Index of Erectile
Function (IIEF-EF). Post-operative urinary function was evaluated with the International Consultation on Incontinence
questionnaire (ICIQ). After surgery functional outcomes were recorded at 2 months after surgery and then every 4 months during
the first year and every 6 months thereafter. EF recovery was defined as a post-operative IIEF-EF >21. UC recovery was defined
as ICIQ score ≤6. Chi-square test evaluated the rates of UC, EF, and both UC and EF recovery (Bifecta) at 2 months after surgery
according to the surgical technique. The role of surgical technique on UC, EF, and Bifecta recovery at 2 months after surgery was
evaluated at univariable and multivariable logistic regression analyses after accounting for the effect of possible confounders (age
at surgery, BMI, pre-operative EF, PSA value, pathological stage and grade). Finally, univariable and multivariable Cox regression
analyses also assessed the role of surgical approach on functional outcomes over time
Results
At a median follow-up of 36 months, 75% and 55% of patients recovered UC and EF, and 616 (43%) patients recovered both
conditions. At 2 months after surgery, UC, EF and Bifecta recovery at 2 months after surgery in men treated with RARP were
significantly higher than patients treated with RRP (52% vs 27%, 22 vs 9%, 15 vs 3%, respectively, all p<0.01)
Discussion
Robotic-assisted surgery provides better early functional outcomes than traditional open approach.
Conclusions
Patients treated with RARP had roughly 4-fold, 3-fold and 6-fold higher probability of UC, EF, and Bifecta recovery at 2 months
after surgery than patients treated with RRP, respectively. The positive impact of a minimally-invasive technique on functional
outcomes remained over time.
Overall, 2,181 patients with intermediate or high-risk PCa (clinical stage ≥T2b, biopsy Gleason score ≥7, and/or preoperative
PSA ≥10ng/ml) treated at a single tertiary referral center between January 2006 and August 2013 were identified.. No patient
received neo-adjuvant or adjuvant therapies. All patients had preoperative and pathological data available. BCR was defined as
the detection of PSA ≥0.2ng/ml after surgery. Early BCR was defined as the occurrence of BCR within 2 years from surgery.
Uni- and multivariable Cox regression analyses evaluated the association between the surgical approach and the risk of BCR and
early BCR, after accounting for confounders. Covariates consisted of clinical stage, biopsy Gleason score, and preoperative PSA.
Subsequently, we evaluated the impact of RARP on the risk of BCR and early BCR after accounting for pathological Gleason
score, pathological stage, surgical margin status, and the receipt of adjuvant treatments.
Results
Mean patient age was 64.9 years (median: 65). Overall, 1,522 (69.8%) and 659 (30.2%) patients were treated with ORP and
RARP, respectively. Overall, the 5-year BCR-free survival rates were 79.8%. The 5-year BCR-free survival rates were 79.8%
and 81.9% in patients treated with ORP and RARP, respectively (P=0.7). At univariable Cox regression analysis, RARP was
not associated with increased risk of BCR (Odds ratio [OR]: 1.27; 95% confidence interval [CI]: 0.72-1.58; P=0.3) and early
BCR (OR: 1.07; 95% CI: 0.78-2.06; P=0.7). This was confirmed at multivariable analyses, where RARP was not associated with
BCR and early BCR, after accounting both for preoperative (PSA, clinical stage, and biopsy Gleason score) and postoperative
(pathological stage, pathological Gleason score, surgical margin status, lymph node invasion, and adjuvant treatments)
confounders (all P>0.1).
Discussion
RARP and ORP have comparable 5-year BCR-free survival rates in patients with intermediate- and high-risk PCa. The results of
our investigation support the oncological safety of RARP in patients with intermediate- and high-risk PCa.
Conclusions
Robotic surgery leads to comparable oncological outcomes in terms of BCR and early BCR.
4
5
P6
P7
INCIDENCE AND PREDICTORS OF 30-DAY READMISSION IN PATIENTS TREATED WITH ROBOT-ASSISTED
RADICAL PROSTATECTOMY
RALP CAN REDUCE THE RATE OF POSITIVE MARGINS: MATCH –PAIR COMPARISON WITH
OPEN PROSTATECTOMY
V. Cucchiara, G. Gandaglia, N. Buffi, M. Moschini, M. Tutolo, D. Vizziello, F. Cantiello, R. Damiano, R. Colombo, A. Salonia, G.
Guazzoni, F. Montorsi, A. Briganti (Milan)
Aim of the study
Although several studies reported advantages related to the adoption of robot-assisted radical prostatectomy (RARP) in terms of
postoperative pain, blood transfusions, and length of hospital stay, evidence is scarce regarding the incidence and predictors of
readmission in these patients.
Overall, 1,402 prostate cancer (PCa) patients treated with RARP at a single center between 2006 and 2013 were identified.
Baseline comorbidities were categorized according to the Charlson comorbidity Index (CCI). Postoperative complications
during the first hospitalization were both categorized using both the Clavien-Dindo classification system and detailed as follows:
bleeding/haematoma, lymphorrhoea/lymphocoeles, fever, urinary fistula, cardiovascular event, and other. Patients experiencing
30-day readmission were identified. Uni- and multivariate logistic regression analyses tested the association between 30-day
readmission and age at surgery, the receipt of pelvic lymph node dissection, CCI, and the severity of postoperative complications
classified according to the Clavien-Dindo system as well as the type of postoperative complications.
Results
Median patient age was 63 years. Overall, 161 (11.5%) patients experienced a postoperative complication during the first
hospitalization. The most frequent type of complication was bleeding/haematoma (6.1%), followed by lymphorrhoea/
lymphocoeles (1.4%). Clavien- Dindo distribution during first hospitalization was 0 in 1241 (88.5%), 1 in 53 (3.8%), 2 in 69
(4.9%) and ≥3 in 39 (2.8%) patients. Overall, 38 patients (2.7%) needed a new hospitalization within 30 days after discharge.
The most common causes of re-hospitalization were fever in 12 patients (31.6%), lymphoceles in 11 (28.9%) and urinary leak
in 6 (15.8%). The proportion of patients who experienced 30-day readmission was significantly higher among patients who
had a complication during the first hospitalization compared to those who did not experience a complication during the first
hospitalization (6.2 vs. 2.3%, respectively; P=0.01). At multivariable analyses, the occurrence of a complication during the first
hospitalization and its severity represented independent predictors of 30-day readmission, after accounting for confounders (all P
Discussion
Our observations show that patients undergoing RARP have a relatively low risk of 30-day readmission (2.7%). Of note, the
occurrence of a postoperative complication represented the only independent predictor of 30-day readmission.
Conclusions
In this context, fever, urinary fistula, and cardiovascular complications represent the type of complications significantly associated
with higher risk of readmission. Our findings highlight the need for better patient management when a complication occurs during
hospitalization for RARP.
M.Sodano*, A.Antonelli*, A.Peroni*, M.Finamanti*, G.Galvagni*, I.Mittino*, F.Carobbio*, C.Simeone*
(*) Spedali Civili di Brescia - Divisione di Urologia
Aim of the study
Analyze the risk of positive margins (PSM) after radical prostatectomy in patients undergoing robotic surgery (RALP) compared with those undergoing open surgery (OP).
In our center the OP is performed according to the technique of Walsh by experienced surgeons (more than
100 procedure). From 2010 was introduced the RALP, performed by three surgeons, one with a previous
experience of OP, the other two without previous experience.From an institutional database that stores from
2008 the data of the patients who underwent radical prostatectomy (335 OP and 253 RALP), was conducted a
propensity-score matched pair analysis with the aim of balancing between the two groups (OP vs RALP) the
following parameters: clinical stage, percentage of cancer compared to prostate volume, pathological stage,
Gleason Score, nerve sparing surgery. We excluded from the analysis patients undergoing preoperative hormone therapy and the first 25 RALP. An analysis of the risk of PSM was conducted by applying a regression
model.
Results
We matched 91 patients undergoing RALP with 91 undergoing OP. The characteristics of the patients are described in the table. The rate of PSM was 35.2% (32/91 patientsi) among OP and 17.6% (16/91) among RALP
(p=0.011); The involvement of the margin was focal in 68.8% of cases, similar for OP (22/32 cases) and RALP
(11/16 cases). Factors that correlated with the risk of PSM were: stage pT3a (RR 3.447, 95% CI 1.664-7.143,
p=0.001); Gleason score >=7 (RR 2.352, 95%CI 1.201-4.606, p=0.013); percentage of cancer compared to prostate volume ( continuous variable, RR 1.030, 95% CI 1.004-1.056, p=0.023); surgical approach (OP vs RALP,
RR 2.542, 95% CI 1.275-5.070, p=0.008). After multivariate analysis, maintained a significant correlation with
the risk of PSM the presence of extra capsular tumor (RR 3.568, 95%CI 1.370-9.293, p=0.009) and the surgical technique (OP vs RALP, RR 3.680, 95%CI 1.691-8.006, p=0.001).
Discussion
The RALP is emerging on the OP, thanks to a proven advantage in the post-operative course and possible
benefits on the recovery of continence and erectile functions.The oncological outcome of the two technique is
considered the same, although some studies suggest lower rate of PSM when using the RALP. This study evaluates the activity of a medium-volume center, and compare an initial experience of RALP, performed mostly
by surgeon without previous experience of prostatectomy, with a series of OP performed by experienced surgeon.After balancing the factors that affect the risk of PSM, the analysis shows that this risk is 2.5 times lower
for RALP compared to OP. In addition the surgical technique and the extracapsular extension of the tumor
are an independent risk factor for PSM.
Conclusions
RALP allows a lower rate of PSM compared to OP, also in an initial experience and with naive surgeons.
6
7
P8
P9
Oncological and functional outcomes of Robotic, Extraperitoneal, Intrafascial
Radical Prostatectomy technique with 360° preservation of the Veil of Aphrodite
POSITIVE SURGICAL MARGINS AFTER MINI-INVASIVE RADICAL PROSTATECTOMY:
A MULTI-INSTITUTIONAL STUDY
Aim of the study. To report the oncological, functional, and peri-operative outcomes of a technique of Extraperitoneal, Robotassisted Radical Prostatectomy (ERARP), with complete preservation of the Veil of Aphrodite, in patients (pt.) with low risk,
organ-confined prostate-cancer.
A. Tafa, G. Albo, E. De Lorenzis, D. Consonni, A. Porreca, A. Celia, A. Antonelli, M. Falsaperla, A. Minervini, P. Parma, S.
Zaramella, P. Bove, C. Ceruti, S. Crivellaro, B. Rocco (Milano)
Materials e methods. We performed 210 ERARP between January 2012 and January 2014. We made a prospective analysis of
80 pt. who underwent to intrafascial technique, with complete preservation of the Veil of Aphrodite. Bilateral lymphadenectomy
was performed when the lymphnode involvement risk was >2%, according to Memorial Sloan-Kettering nomograms. Functional
outcomes were evaluated at a median follow-up of 6 months. We considered fully continent the pt. who used no pad, slightly
incontinent the ones who used 1 pad/die and incontinent the pt. who used more than 1 pad/die. We evaluated pre- and postoperative sexual potency using the IIEF-5 score. All pt. were pre-operative potents (IIEF-5 >17). Mean age was 61 years. In the
post-operative evaluation, we considered potent pt. with an IIEF-5 score >17, potent with drug, the pt. who need drugs to reach the
IIEF-5 score >17, and unpotent the pt. with IIEF-5 <17.
Results. Mean operative time was 143 minutes. Estimated mean blood loss: 298 ml. No patient needs conversion to open surgery.
Grade I complications, according to Clavien-Dindo, were 17,5% (14/80), II grade ones were 3,75% (3/80), only 1 patients
(1,25%) experienced IIIb grade complication. At 1 month from surgery, 70/80 (87,5%) pt. were fully continent, 6/80 (7, 5%)
slightly incontinent, and 4/80 (5%) incontinent. At 6 months 92,8% (65/70) were continent and 5 (7,2%) were slightly incontinent.
After surgery 65/80 (81,25%) pt. were potent: 38/65 (58,45%) without use of drugs and 27/65 (41,55%) potent with drug. 15/80
(18,75%) pt. were unpotent. The Gleason Score (GS) upstaging on specimen, occured in 26,25% (21/80) of cases. Positive
surgical margins (PSMs) were retrived in 15% of pt. (12/80), of which 41,6% (5/12) focal PSM, and 16,6% (2/12) multiple
PSMs. 50% (6/12) of pt. with PSMs experienced also a GS upstaging, no one of them with lymphnode involvement. 11,25% of pt.
(9/80) needed adjuvant RT.
Discussion. The 360° preservation of the Veil of Aphrodite consents a wide preservation of the neuro-vascolar structures, who
surrounded the prostate. In low risk disease, the possibility to perform an intrafascial technique should not be compromised by
the greater risk to observe PSMs, considering the reduced prognostic impact of focal PSMs in pt. without GS upstaging. Reaching
earlier continence and potency consituted an important psychological factor for these pt. Upstaging risk persists in this kind of
surgery. In these cases the adjuvant RT becomes needful in presence of PSMs.
Conclusion. The intrafascial technique consents to reach good functional results and low rates of complications, maintaning good
oncological outcomes.
8
Aim of the study
Positive surgical margins (PSMs) are a known risk factor for biochemical recurrence in prostate cancer (PCa) and are potentially
affected by surgical technique. We investigated whether mini-invasive radical prostatectomy (RP) modality affects PSM rates and
analyzed the incidence and the associative factors for PSMs in a multi-institutional series of 1357 robotic and 635 laparoscopic
RP.
We retrospectively analyzed 1992 patients with clinically localized PCa treated with laparoscopic RP (LRP) or robot assisted RP
(RARP) by one of 35 surgeons from eleven institutions in Italy between January 2008 and March 2014. We had no data about
margin status in 177 patients (123 LRP, 54 RARP). Patients were excluded from analysis if they had previously received androgen
deprivation therapy or radiation therapy to the pelvis. PSMs were defined as cancer at the inked margin. 1159 patients were
available for multivariate analysis.
Results
PSM rates were 24.1% and 20.2% for RARP and LRP respectively (p=0.074). Pathological stages were pT2 in 84,6% and pT3 in
15,4 % of patients for LRP and pT2 in 75,8% and pT3 in 24,2% of patients for RARP (p
Discussion
In our cohort PSA and NS procedure had no statistically significant impact on the PSM rates on multivariate analysis. There
was no significant difference on PSM rates between the two analyzed surgical technique, however RARP tended to have higher
rates. This may be explained with more pT3 and pGS ≥ 7 patients present in the RARP cohort, which were the most important
predictive factors for PSMs on multivariate analyses, and the possible presence of the robotic RP surgeons at their initial learning
curve. Limits of this study are: it’s not randomized nature, missing data across covariates, lack of central pathology review, lack
of information for potential confounders (comorbidity, tumor volume, surgeon caseload and non entering on multivariate analysis
other variables such body mass index, preoperative GS and clinical stage).
Conclusions
There is no significant difference between LRP and RARP for PSMs, with tendency of the robotic modality to operate higher pT
stage PCa patients. Pathological stage and postoperative GS were the most important factors independently associated with an
increased risk of PSMs after mini-invasive RP.
9
P 10
P 11
Retzius-sparing approach for Robot-Assisted laparoscopic Radical Prostatectomy
(RARP): is it feasible and safe in intermediate and high risk prostate cancer?
SURGICAL MARGINS LESS THAN 1 MM HAVE NO EFFECT ON BIOCHEMICAL
RECURRENCE AFTER ROBOTIC RADICAL PROSTATECTOMY
Antonio Galfano, Dario Di Trapani, Silvia Secco, Giovanni Petralia, Elena Strada, Aldo Massimo Bocciardi
Urology Department, Niguarda Ca’ Granda Hospital, Milan, Italy
G. D’Elia, P. Emiliozzi, A. Iannello, A. Cardi, A. De Vico, B. Tassi, T. Riga, A. Scapellato (Roma)
Introduction: Robot-Assisted Laparoscopic Radical Prostatectomy (RARP) has become the main surgical option for localized
prostate cancer. In 2010, in the Urological Department of Hospital Niguarda Ca’ Granda, Milan was developed a novel approach for
RARP, passing exclusively through the Douglas space and avoiding all the Retzius structures involved in continence and potency
preservation. After the first 50 low-risk patients, non other patients was selected and was performed this kind of approach in any case
where radical prostratectomy was indicated.
Objective of our work is to report the oncological and functional results of the Retzius-sparing approach for RARP (RS-RARP) in
patient with intermediate and high risk prostate cancer.
Aim of the study
Positive surgical margins (SM) are universally acknowledged as an independent predictor of biochemical
recurrence after open radical prostatectomy. Howewer, it is not clear whether tumor distance less than 1
mm from the surgical margin might affect biochemical failure. We assessed the impact on biochemical
recurrence in men with robotic radical prostatectomy specimens having negative SM, positive SM and SM
less than 1 mm.
Materials and Methods: The patients eligible and included in the study were 179.
All the patients underwent RS-RARP and pelvic lymph node dissection for intermediate and high-risk prostate cancer between
January 2010 and September 2013 were included in the study. Risk stratification was performed according to D’Amico classification.
The series was divided into two groups (case 1-90 versus case 91-179) in order to evaluate the learning curve effect.
All perioperative, oncological and functional data were prospectively recorded. A suprapubic tube was positioned instead of
transurethral catheter in all cases were no major contraindication was present (history of bladder cancer) and when the anastomosis
was water-tight to a 300 cc saline water filling. Potency was defined as IIEF5>17; continence as no pad or 1 safety liner. Oncological
results were reported as positive surgical margins (PSM) and biochemical disease-free survival. Recurrence was defined as a repeated
PSA>0,2 ng/ml. Complications were graded according to the Clavien Dindo system.
Results: The patients eligible and included in the study were 179. Median age was 66 (IQR 60-70). Median BMI was 25,3 (IQR
24,1-26,4). Median PSA at diagnosis was 9 ng/ml (IQR 6-13). Median surgical time was 210 (IQR 185-245) minutes; median
console time for the radical prostatectomy was 95 minutes (IQR 80-110). Thirteen patients had a previous prostatic surgery (6,7%).
Regarding clinical stage, 2 (1,1%) patients had cT1b, 50 patients (27,9%) had cT1c, 114 (63,7%) cT2 and 13 (7,3%) a cT3-4
disease. Biopsy Gleason Score was 6 in 37 (20,7%), 7 in 104 (58,1%), 8 in 27 (15,1%), 9 in 10 (5,6%) and 10 in 1 (0,6%) patients. In
summary, 127 (70,9%) had an intermediate risk and 52 (29,1%) a high risk prostate cancer. A suprapubic cistostomy was positioned
in 122 (68,1%) of patients. The bladder neck was preserved in 168 (93,9%) patients. The procedure was a bilateral nerve-sparing in
90 (51,7%), monolateral nerve-sparing in 61 (35,1%) and non nerve-sparing in 23 (13,2%) patients.
Overall, we had 42 complications in 38 patients (21,2%): 23 Clavien Dindo grado I-II (12,7%) ; 14 (7,4%) IIIa ; 5 IIIb (2,7%); any
IV-V.
Pathological stage was pT2 in 87 (48,6%) patients, pT3a in 66 (36,9%), pT3b in 25 (14%) and pT4 in 1 (0,6%) patient. Median
number of lymph nodes removed during lymphadenectomy was 20 (IQR 16-25); 161 (89,9%) patients were pN0, 18 (10,1%) were
pN+. Pathological Gleason Score was 6 in 29 (16,5%), 7 in 105 (58,7%), 8 in 23 (12,8%), 9 in 19 (10,6%) patients; in 3 (1,7%)
patients Gleason score was not assigned for previous hormonal treatment.
Overall, PSMs were recorded in 10/87 pT2 patients (11,4%) and in 37/66 (56,1%) pT3a and in 8/26 (30,7%) T3b-T4 patients (only
1 T4). Radiotherapy was performed in an adjuvant setting in 36 (20,1%) patients and as a salvage treatment in 8 (4,4%).
At a median 18 months follow-up, biochemical disease-free survival (bDFS) was 92%.
Immediate continence was reached in 84,7% of patients; after 1 year of follow-up, continence rate was 91,8%.
Patients with intermediate risk prostate cancer had immediate continence in 90,7% of cases, 70,6% in high risk patients.
After 1 year of follow-up, continence rate for intermediate risk patients was 94,2% and 86,3% in high risk patients.
Overall, 35,9% had IIEF>17 after 1 year of follow-up. Considering the 38 preoperatively potent patients <65 who underwent bilateral
intrafascial nerve-sparing surgery and did not receive radiotherapy and/or hormonal treatments, 100% of them were continent and
65,8% of them were potent at 1 year of follow-up.
A consecutive series of 400 men undergoing robotic radical prostatectomy with a minimum follow up
of 24 months was divided into 3 groups based on margin status: negative, positive and less than 1 mm.
Biochemical recurrence was defined as PSA greater than 0,2 ng/ml on 2 consecutive tests. Cox regression
models were constructed to evaluate predictors of biochemical recurrence.
Results
A total of 40 patients (10%) had margins less than 1 mm, 60 patients (15%) had positive margins (8 % of
T2 and 26 % of pT3) and 312 patients (75%) had negative margins. Preoperative PSA, pathological stage,
Gleason score, and margin status were independent predictors of biochemical recurrence. Patients with
negative SM and those with a SM less than 1 mm had similar rates of biochemical recurrence (log rank test
p _ 0.18).
Discussion
Surgical margins less than 1 mm seem to have no effect on biochemical recurrence after robotic radical
prostatectomy. Longer followup is necessary for confirmation of this finding.
Conclusions
Surgical margins less than 1 mm seem to have no effect on biochemical recurrence after robotic radical
prostatectomy. Longer followup is necessary for confirmation of this finding.
Conclusions: This data demonstrate that Retzius-sparing approach in patients with intermediate and high risk prostate cancer is
oncologically safe, allowing a high early continence rate and potency rates.
10
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P 12
P 13
THE SELECTION OF CANDIDATES TO ROBOT-ASSISTED RADICAL PROSTATECTOMY
IS STRONGLY AFFECTED BY SURGICAL EXPERIENCE: RESULTS FROM A TERTIARY
REFERRAL CENTER.
A QUANTITATIVE EMG ANALYSIS OF THE EXTERNAL URETHRAL SPHINCTER IN
CONTINENT MALES WITH PROSTATIC PATHOLOGY
L. Villa, G. Gandaglia, N. Fossati, M. Moschini, M. Bianchi, V. Cucchiara, N. Suardi, R. Lucianò, M.
Freschi, V. Mirone, A. Salonia, F. Montorsi, A. Briganti (milano)
Aim of the study
Previous studies showed that the prostate cancer (PCa) patients receiving robot-assisted radical
prostatectomy (RARP) have better baseline characteristics compared to their open counterparts. These
findings might be related to the learning-curve phenomenon typical of early adopters, where less
experienced surgeons are more likely to treat patients with more favorable disease. We hypothesized that
these observations do not apply to experienced surgeons.
Overall, 1,265 patients with PCa treated with RARP by the seven surgeons at a single tertiary referral center
between February 2006 and August 2013 were identified. No patient received neo-adjuvant or adjuvant
therapies. All patients had preoperative and pathological data available. Surgical volume was coded as the
number of robotic cases done by the surgeon before the index patient’s operation. Associations between
patient characteristics and surgeon experience were tested using linear regression (age, and PSA) or ordinal
logistic regression (Charlson comorbidity index [CCI], clinical stage, biopsy Gleason score, and D’Amico
risk group). These models were fitted with general estimation equations for clustering among surgeons.
Results
Mean patient age was 62.5 years (median: 63). Mean surgical volume was 182 (median: 173; interquartile
range [IQR]: 62-289). There was no association between surgeon experience and age, CCI, and preoperative
PSA (all P≥0.4). We observed a statistically significant association between surgeon experience and clinical
stage, biopsy Gleason score, and risk group, with more experienced surgeons less likely to treat patients with
clinical stage ≤T2a, biopsy Gleason score ≤6, and low-risk disease (all P≤0.002). Particularly, the proportion
of patients with clinical stage ≤T2a decreased from 75.9 to 60.5% for surgeons who have done less than 100
and more than 300 procedures, respectively (P<0.001).
Discussion
While less experienced surgeons are more likely to treat patients with favorable disease, the likelihood of
performing surgery in patients with high-risk PCa increased with surgical experience, presumably because
of improved surgical technique.
Conclusions
The increase in surgical experience with robotic surgery leads to the treatment of patients with more
aggressive disease characteristics.
F. Bianchi, M. Cursi , M. Ferrari , G. La Croce , A. Salonia , H. Danuser, U. Del Carro , A. Mattei (Milano,
Italia )
Scopo del lavoro
The aim of this study was to evaluate the external urethral sphincter (EUS) functionality using quantitative
EMG analysis in a cohort of neurologically healthy men with prostatic pathology, in order to verify the
presence of predictive risk factors in patients with prostatic cancer (PCa) and developing post-surgical
urinary incontinence.
Materiali e metodi
66 continent men (mean age: 64.38, range 51-86) without neurological disorders were included. A
concentric needle EMG analysis of the EUS was performed immediatly before prostatic biopsy, carried out
for suspected prostatic cancer. The examination was performed using transperineal approach and transrectal
ultrasound guidance. Motor Unit Potentials (MUPs) and Interference Pattern (IP) analysis were obtained
from each muscle, respectively using multi-MUP and turns/amplitude automatic analysis. MUPs were
collected at slight voluntary and reflex activation, and only muscles with 15 or more MUPs sampled were
included1. IP samples were automatically recorded from different sites in both part of EUS, at different level
of voluntary and reflex muscle activation. Muscles with less than 15 samples were excluded. Depending of
the results of the biopsy patients were divided in the following groups: benign prostatic hypertrophy (BPH)
and prostatic cancer (PCa). Patients with Pca underwent robot assisted radical prostatectomy. The mean
values for individual MUP and IP parameters and the turn/amplitude “cloud”, obtained using the concepts
developed by Stalberg2, were determined respectively for the two groups.
Risultati
A mean of 22 different MUPs was collected from each muscle (range: 15-40), for a total of 1290. No
statistical differences were found between groups, therefore BPH and PCa values have been joined to create
a reference pool of data (Tab. 1). Moreover our values were not different from those previously reperted in
female EUS3 and in external anal sphincter1 in normal populations. A mean of 33 different IP samples were
obtained from each patient (range: 15-50), for a total of 2086. The regression analysis on log-transformed
turns/s and amplitude values was performed for the two groups. The resulting regression lines had slope
and intercept: bBPH=0.234, aBPH=1.962 and bPCa=0.233, PCa=1.956 respectively. The statistical
comparison between the two regression lines was not significant, so the distribution of the two clouds could
be considered identical (Fig.1). In addition preoperative EMG data of patients developing incontinence after
surgery were not significantly different from those of patiens maintaining continence, suggesting that there
were no predictive factors of post-surgical continence outcome.
Discussione
Our data could be considered a valid reference to compare EMG parameters of patients developing urinary
incontinence after prostatic surgery.
Conclusioni
EMG is a new application usefull to verify a possible involvement of EUS on continence status
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P 14
P 15
ASSOCIAZIONE TRA STUDIO URODINAMICO E FUNZIONE SESSUALE IN PAZIENTI
MASCHI AFFETTI DA SCLEROSI MULTIPLA.
BLADDER FILLING ATTENUATES SPINAL CORD NOCICEPTIVE REFLEXES IN HUMANS
A. Di Rosa, E. Fragalà, R. Giardina, S. Cimino, G. Russo, A. Caramma, F. Patti, G. Morgia (Catania)
Scopo del lavoro
La sclerosi multipla (SM) è una patologia neurodegenerativa cronica a patogenesi autoimmune, con aspetti
di demielinizzazione ed infiammazione. Si possono distinguere diverse tipologie di sclerosi multipla:
recidivante-remittente (SM-RR), primitivamente progressiva (SM-PP) e secondariamente progressiva
(SM-SP). Obiettivo di questo studio è di valutare l’associazione tra le varianti cliniche di SM e la funzione
sessuale in pazienti maschi affetti da SM.
Materiali e metodi
Da gennaio 2011 a Settembre 2013 è stata reclutata una coorte di 60 pazienti maschi affetti da sclerosi
multipla afferenti al servizio ambulatoriale di SM che sono stati sottoposti per la prima volta ad esame
urodinamico. Sono stati seguiti i seguenti criteri di inclusione: diagnosi di SM secondo i criteri di McDonald
(2005) e una “relazione sessuale stabile”, definita come la presenza dello stesso partner per sei o più mesi
consecutivi . L’indicazione ad esame urodinamico è stata posta in seguito a: frequenza minzionale diurna
≥ 8 o nicturia ≥ 1, urgenza minzionale e/o incontinenza urinaria. La depressione ed il disturbo d’ansia sono
stati valutati rispettivamente mediante Hamilton Depression Scale (HAM-D) ed Hamilton Anxiety Scale
(HAM-A). La funzione sessuale è stata determinata attraverso i questionari International Index of Erectile
Function (IIEF-15) e Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ).
Risultati
La mediana dell’ età è risultata pari a 47,0 anni (IQR : 39,0-53,0). Sei pazienti (10,0%) presentavano la
forma SM-PP, 14 (23,3%) la forma SM-SP e 94 (66,7%) il fenotipo SM-RR. È stato documentato che i
pazienti con fenotipo SM-RR totalizzavano un punteggio IIEF-EF maggiore dei soggetti con SM-PP (18.60
vs 10.66, p< 0.05) è risultata essere fattore predittivo indipendente di Disfunzione Sessuale (SD) moderatagrave (IIEF-EF≤16) dopo aggiustamento per le varianti cliniche di SM e per età.
Discussione
Nel presente studio è stato ipotizzato che le alterazioni vescicali secondarie a SM, valutate mediante esame
urodinamico, siano predittive di DS in soggetti maschi. Infatti, CC è risultata essere predittiva di DE mediograve.
C. Maggioni, M. Serrao, F. Cortese, G. Fragiotta, A. Pastore, G. Palleschi, G. Coppola, F. Pierelli, A.
Carbone (Latina)
Aim of the study
To examine the viscerosomatic interaction between bladder afferents and somatic nociception we evaluated
the effect of bladder filling on the nociceptive withdrawal reflex (NWR) in 21 healthy subjects.
NWR was evoked in the lower and upper limbs by stimulating the sural and index finger digital nerves,
respectively, while simultaneously recording EMG activity in the biceps femoris and biceps brachialis.
NWR pain-related perception was quantified on a 10-point pain scale. Bladder filling was evaluated with
suprapubic bladder sonography. Subjects were examined during empty bladder, medium and high level of
bladder filling sessions.
Results
NWR magnitude in both upper and lower limbs and perceived pain for the upper limb were significantly
decreased at higher levels of bladder filling compared to empty bladder sessions.
Discussion
The effect of bladder filling on the NWR may represent a useful tool to investigate interactions between
the neural pathways controlling the bladder and pain. The NWR was reduced in both upper and lower
limbs during bladder filling which strongly indicates that bladder control and nociception share common
modulatory descending pathways. The effect of bladder filling on the NWR may represent a useful tool to
investigate interactions between the neural pathways controlling the bladder and pain.
Conclusions
Reduced NWR magnitude in both upper and lower limbs during bladder filling strongly indicates that
bladder control and nociception share common modulatory descending pathways. Bladder afferents may
activate these pathways to suppress the micturition reflex, but they may also inhibit spinal reflexes to
maintain continence during pain stimuli.
Conclusioni
Risulta quindi opportuno considerare la presenza di DS nei pazienti affetti da sclerosi multipla come parte
della valutazione di base, in particolare nei soggetti con alterazione della CC.
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P 16
P 17
CONSISTENT LONG-TERM EFFICACY AND SAFETY OF ONABOTULINUMTOXINA
IN PATIENTS WITH NEUROGENIC DETRUSOR OVERACTIVITY: FINAL RESULTS OF
REPEATED TREATMENTS UP TO 4 YEARS
DESMOPRESSINA NEL TRATTAMENTO DELLA NICTURIA NEI PAZIENTI AFFETTI DA
VESCICA NEUROLOGICA
G. Del Popolo, G. Karsenty, H. Schulte-Baukloh, R. Dmochowski, K. Ethans, B. Jenkins, S. Guard, Y.
Zheng, M. Kennelly (Firenze)
Scopo del lavoro
OnabotulinumtoxinA (onabotA) has been shown to be well tolerated and effective in the treatment of
urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO) in patients who are not adequately
managed with at least 1 anticholinergic (ACH). Here we present final results from a large, multicentre study
of long-term onabotA for UI due to NDO, in which patients received up to 4 years’ treatment.
Materiali e metodi
Patients who completed a 52-week phase 3 study could receive multiple intradetrusor onabotA treatments
(200U or 300U) in a 3-year extension study. After regulatory approval of onabotA 200U for treatment of
UI due to NDO, the trial protocol was amended so that all patients subsequently received 200U. Treatment
schedules were individualised based upon patient request/need for retreatment and a predefined UI
threshold, and required at least 12 weeks since previous treatment. Data are presented by treatment cycle (ie,
the 1st, 2nd, 3rd, etc, onabotA treatment received; up to 8). Assessments included change in UI episodes/
day (primary efficacy measure) and volume/void, adverse events (AEs), and de novo clean intermittent
catheterisation (CIC).
Risultati
388 patients received at least 1 onabotA treatment over 4 years. Discontinuation rates due to AEs/lack of
efficacy were 3.1%/2.1%; overall discontinuation rate was 41.5%. The number of treatments each patient
received during the study varied because they were treated on an ‘as needed’ basis (based on patient request
and investigator assessment of prespecified retreatment criteria); most patients (77.8%) received 5 or fewer
treatments. OnabotA 200U consistently reduced UI episodes/day at week 6; reductions from baseline
were -3.2, -3.3, -3.5, -3.5, -3.6, -4.1, -3.8, and -3.8 (cycles 1-8, respectively). Volume/void increased after
onabotA; increases from baseline at week 6 ranged from 133.2-166.1mL. Efficacy results for onabotA 300U
(which some patients received before the protocol amendment) were similar. Median duration of effect for
onabotA 200U and 300U was similar (36.2 and 36.6 weeks, respectively). Most common AEs were urinary
tract infections and urinary retention. De novo CIC rates (onabotA 200U) were 29.5%, 3.4%, and 6.0% for
cycles 1-3, and 0% for cycles 4-8. CIC rates were higher with 300U than 200U.
M. Gubbiotti, J. Rossi de Vermandois, S. Proietti, M. Porena, A. Giannantoni (Perugia)
Scopo del lavoro
Attualmente è conosciuta l’efficacia e la tollerabilità della Desmopressina nel trattamento di pazienti
affetti da nicturia ma esitono poche informazioni riguardo il suo utilizzo nei pazienti affetti da Malattia
di Parkinson (PD) o Sclerosi Multipla (SM). Scopo dello studio è stato quello di valutare l’efficacia e la
sicurezza della Desmopressina in pazienti con PD o SM affetti da nicturia, in un follow-up a medio termine.
Materiali e metodi
Sono stati arruolati 32 pazienti affetti da PD ed 11 con SM. Criteri d’inclusione: presenza di nicturia,
nicturia index score >1 e sodiemia >135 mmol/l.Criteri d’esclusione: presenza di ritenzione urinaria, di
residuo post- minzionale >150 ml, ipertensione arteriosa sistemica non controllata. Dopo una valutazione
basale che includeva un diario minzionale di 7 giorni, valutazione della sodiemia ed il questionario Nocturia
Quality of Life (N-QoL), i pazienti sono stati sottoposti a trattamento con Desmopressina 60 µg sublinguale
assunta prima di coricarsi per 7 giorni. I pazienti con una riduzione delle minzioni notturne >\= al 50%,
hanno continuato con il farmaco allo stesso dosaggio per 24 settimane. Coloro che non hanno ottenuto lo
stesso risultato, dopo una settimana, hanno assunto Desmopressina 120 µg per 7 giorni. Il diario minzionale,
la valutazione della sodiemia ed il questionario N-QoL sono stati ripetuti dopo 1, 12 e 24 settimane dal
trattamento. Obiettivo primario: la riduzione di almeno il 50% del numero delle minzioni notturne. Obiettivo
secondario: la riduzione del volume urinario notturno, l’allungamento del tempo di sonno antecedente la
prima minzione notturna, il miglioramento della QoL.
Risultati
Ad una settimana dall’inizio della terapia si è osservata una riduzione significativa (>50%) del numero
medio delle minzioni notturne, del volume medio urinario notturno, un significativo incremento della
durata media del periodo di sonno antecedente la prima minzione notturna e dello score totale medio del
questionario N-QoL in 19 pazienti (44.1%), che hanno continuato ad assumere Desmopressina 60 µg per
24 settimane. 13 pazienti (30.2%) hanno interrotto il trattamento per vomito e diarrea. 11 pazienti hanno
necessitato di aumentare il dosaggio di Desmopressina a 120 µg; 9 di essi hanno continuato la terapia per
24 settimane mentre 2 pazienti hanno interrotto l’assunzione del farmaco per una riduzione del valore di
sodiemia. Pertanto, a 24 settimane di follow- up, 28 pazienti(65.12%)hanno riportato un miglioramento di
tutti i parametri considerati.(Tabella)
Discussione
To our knowledge, these data represent the longest longitudinal follow-up from a large, prospective,
multicentre, interventional trial of a UI treatment in an NDO population. Symptom improvement following
onabotA is sustained for up to 4 years with no new safety signals. These results further support the use of
onabotA 200U in patients with NDO and UI who are not adequately managed by at least 1 ACH.
Discussione
Nei pazienti affetti da PD o SM, la nicturia è uno dei sintomi che influisce maggiormente sulla QoL. Il
presente studio dimostra che la Desmopressina è in grado di ridurre significativamente la frequenza della
nicturia, di aumentare il tempo di sonno fino alla prima minzione e di migliorare la QoL in circa il 65% dei
pazienti, senza effetti avversi nella maggior parte dei casi.
Conclusioni
This large 4-year study of repeat onabotA treatment in patients with UI due to NDO demonstrated consistent
improvement in UI and volume/void through 8 cycles. OnabotA was well tolerated, with no new safety
signals identified over 4 years’ follow-up.
Conclusioni
La Desmopressina risulta efficace e tollerabile nella terapia della nicturia dei pazienti neurologici.
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P 18
P 19
ENDOSCOPIC CORRECTION OF VESICOURETERAL REFLUX IN NEUROGENIC BLADDER
INTRADURAL RELEASE OF FILUM TERMINALIS IN OCCULT TETHERED CORD
SYNDROME (OCTS): DOES IT WORK ?
E. ANDRETTA, O. RISI, G. ARTUSO, F. BATTAGLINO, M. PASTORELLO (DOLO)
Scopo del lavoro
Endoscopic treatment has become the gold standard therapy for vesicoureteral reflux (VUR). We assessed
the outcome of this therapy in adults patients (pts) with neurogenic bladder (NB)
Materiali e metodi
19 pts (16 males and 3 females, mean age 32±6.2 years) were recruited in 4 centres. NB was due to spinal
cord injury (SCI) in 74% of cases and spina bifida in 26% and the same mean grade of reflux of 2.8 was
present in the 2 groups. 15 pts (79%) had an overactive NB - 9 of them with dyssinergia -, 84% voided
by clean intermittent catheterization (CIC) and 79% were treated with anticholinergics and/or detrusorial
injections of botulinum toxin A. The VUR was diagnosed by videourodinamics in 53% of cases. The VUR,
detected in 23 ureteral units (UU), was mainly monolateral (79%) and passive (53%); the degree was 1-2^
in 31,6% UU, 3^ in 52,6% and 4^ in 15.8%.. In 2 pts a monolateral, passive and 3^ grade VUR was relapsed
to the surgical correction according to the Cohen technique; in another case the VUR concerned an ureteral
stump. 21 UU were injected with the sting technique; in 1 bilateral VUR the Hydrodistention Implantation
Tecnique was adopted. The bulking agents were Deflux (58.5% UU), Coaptite (26.5% UU), Durasphere
(10% UU) and Vantris (5% UU) at the mean dose of 1.03±0.36 ml. The median follow-up was 36±9.9
months.
Risultati
The success rate was 69.6% (16/23 refluxes eliminated); in 7 UU (30.4%) the VUR downgraded to 1^
degree. In 37% of pts were necessary additional therapies, especially detrusorial injections of botulinum
toxin A. No complications were observed. In 7 UU (30%) the endoscopic treatment was repeated within
1 year at a mean time of 8.6 months (range 6-12). A lower success rate was observed in high degree
VUR (reflux of 1^-2^ grade cured in 100% of UU, 3^ grade cured in 70% and 4^ grade cured in 33%), in
congenital NB (40% VUR cured in spina bifida against 78.6% in SCI) and in patients who didn’t void by
CIC (66% cured against 75% in pts in CIC).
Discussione
No exacerbation of hydronephrosis was observed postoperatively, and no complication was noted. This
procedure, which is minimally invasive and technically simple, may be regarded as the first choice for VUR
secondary to neurogenic bladder dysfunction.
M. Taverna, F. Pistolesi, L. Luca, A. Elia, F. Giordano, D. Danti (Firenze)
Scopo del lavoro
Occult Tethered Cord Syndrome (OTCS) is characterized by urological complaints (i.e. hyperactive bladder)
and sometimes leg and back pain without clearcut radiological signs of tethered cord. Intradural section of
filum terminalis is a surgical option though its real efficacy is still to be confirmed. Aim of this study is the
analysis of surgical outcomes in a series of eleven patients with OTCS.
Materiali e metodi
Since 2009 eleven patients fullfilling all diagnostic criteria underwent intradural release of filum terminalis.
There were 7 males and 4 males; mean age was 11 years (range 4 – 19 years). Average duration of symptoms
were 31.3 months (range 12-84 mos). Clinical findings were: urinary (8) and fecal incontince (1), recurrent
urinary tract infections (2). All patients received a complete urological work-up to rule out other etiology.
Medical treatment with oxybutinin was tried before surgery.
Risultati
After 10.8 months mean follow-up (range 6 – 30 mos) nine patients referred a subjective improvement of
urological complaints; two subjects did not feel any variation. None of the patients worsened after surgery.
Post-operative urodynamic testing showed objective improvement of bladder function in two patients. In one
child there was a complete normalization of bladder activity.
Discussione
Surgical morbidty occurred in one girl because of CSF leak with pseudomenyngocele that needed a surgical
repair.
Conclusioni
These results confirm intradural section of filum terminalis as a possible treatment for OCTS after failure
of conservative therapies. However, larger series and longer follow-up are needed to definitely validate this
surgical option.
Conclusioni
The endoscopic subureteral injection of bulking agents is simple and has a good success rate – about 70% also in adults with NB and it is inseparable from the contemporary management of the bladder dysfunction.
We observed a scarce use of non-biodegradable agents (5%) and reflux recurrences in 30% of cases.
Therefore we suggest a more extensive use of non-biodegradable agents, especially in case of passive VUR.
The absorbable materials could maintain a temporary role waiting the benefits of therapies for the bladder
dysfunction or in order to predict the outcome of the endoscopic subureteral injection.
18
19
P 20
P 21
L’INFLUENZA DELL’ IPERATTIVITà DETRUSORIALE E DELLA DISABILITà, SULLA
FUNZIONE SESSUALE DEI PAZIENTI AFFETTI DA SCLEROSI MULTIPLA
LA DEPRESSIONE E UN ALTO LIVELLO DI DISABILITA’ SONO FATTORI PREDITTIVI DI
DISFUNZIONE SESSUALE NEI PAZIENTI CON SCLEROSI MULTIPLA: ANALISI DA UNO
STUDIO TRASVERSALE
E. Fragalà, R. Giardina, A. Di Rosa, S. Cimino, G. Russo, A. Caramma, F. Patti, G. Morgia (Catania)
Scopo del lavoro
La Sclerosi Multipla (SM) è una patologia neurologica cronica con un impatto negativo sull’attività sessuale.
L’obiettivo di questo studio mira alla valutazione, nei pazienti con SM, della relazione esistente tra funzione
sessuale, parametri urodinamici , ansia, depressione e disabilità.
Materiali e metodi
Una serie di 135 pazienti con SM, sottoposti prima ad esame urodinamico, è stata reclutata tra gennaio 2011
e settembre 2013 dall’ambulatorio di SM. I criteri d’inclusione prevedevano: diagnosi di SM in accordo con
i McDonald Revised Criteria, e una vita sessuale stabile (definita come presenza di un partner sessuale fisso
da 6 o più mesi consecutivi). L’indicazione all’esame urodinamico è stata data se sussisteva: pollachiuria
(aumento della frequenza minzionale) ≥ 8 atti minzionali al giorno, nicturia >3 atti minzionali durante le
ore del coricamento, urgenza e incontinenza. Ansia e depressione sono state valutate tramite Hamilton
Depression Scale (HAM-D) e Hamilton Anxiety Scale (HAM-A). La funzione sessuale è stata valutata
tramite il Female Sexual Function Index (FSFI) o Internetional Index of Erectil Function ( IIEF-15) e il
Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ).
Risultati
I pazienti reclutati erano 60 (44,4%) donne e 75 (55,6%) uomini, con età media di 47,0 anni (IQR: 39,053,0). All’esame urodinamico 72 (53,3%) avevano iperattività detrusoriale(ID). E’ risultato che le pazienti
con più alto EDSS (4,5-8) avevano un basso FSFI-eccitazione (2,7 vs. 3,29: p
Discussione
Diversi studi hanno recentemente messo in evidenza l’importante compromissione della funzione sessuale e
della funzionalità vescicale nei pazienti con SM. Abbiamo dimostrato per la prima volta come la presenza di
ID rappresenti un fattore predittivo negativo di disfunzione sessuale.
E. Fragalà, A. Di Rosa, R. Giardina, S. Cimino, G. Russo, A. Caramma, F. Patti, G. Morgia (Catania)
Scopo del lavoro
La sclerosi multipla (SM ) è una malattia cronica che ha un impatto negativo sulla vita sessuale dell’adulto.
I disturbi della funzione sessuale possono insorgere in qualsiasi momento durante il corso della SM, la
sua prevalenza varia tra il 50% e il 90%. Lo scopo di questo studio è stato quello di valutare la relazione
tra funzione sessuale e pattern urodinamici nei pazienti con SM, tenendo conto anche del ruolo della
depressione e dell’ansia sulla funzione sessuale .
Materiali e metodi
UUna serie di 135 pazienti con sclerosi multipla , sottoposti a primo esame urodinamico, è stata reclutata
dal gennaio 2011 al settembre 2013 dall’ambulatorio di SM. I criteri di inclusione sono stati: diagnosi
di SM secondo i criteri di McDonald rivisti e una “vita sessuale stabile”, definita come la presenza degli
stessi partner per sei o più mesi consecutivi. L’Indicazioni per esame urodinamico sono state: frequenza ≥8
minzioni al giorno o ≥3 durante la notte, l’urgenza minzionale e/o incontinenza urinaria. Depressione e ansia
sono state valutate con l’ Hamilton Depression Scale (HAM-D) e l’ Hamilton Anxiety Scale (HAM-A). La
funzione sessuale è stata valutata con il Female Sexual Function Index (FSFI) o l’IIEF-5.
Risultati
Di tutti i soggetti, 50 ( 46,3 % ) erano di sesso femminile e 58 ( 53.7 %) erano di sesso maschile. L’età
media era di 46.50 anni (IQR: 40,0-53,0 ), la durata mediana della MS era di 156 mesi (IQR: 60,0-228,0),
la mediana dell’Expanded Disability Status Scale (EDSS) era di 4.25 (IQR: 2,0-6,0). Dopo l’esame
urodinamico, in 68 (63%) e’ stata dimostrata la presenza di Iperattività detrusoriale (ID). Abbiamo
riscontrato che i pazienti con elevata EDSS (4.5-8) avevano più basso IIEF-5 (9.0 vs 13.5, p < 0.01) ed FSFI
(9.9 vs 17.1, p < 0.01) rispetto a quelli con basso EDSS (0-4.5) e che i pazienti di sesso femminile con DO
avevano un FSFI più basso (11.7 vs 16.9, p
Conclusioni
Disabilità, depressione e iperattività detrusoriale, sono fattori associati alla presenza di disfunzione sessuale
nei pazienti con SM. A questo proposito, i farmaci anti- colinergici comunemente utilizzati per il sollievo dai
sintomi da ID potrebbero anche dare giovamento alla funzione sessuale. Ulteriori studi saranno necessari per
approfondire questa associazione.
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LE INFILTRAZIONI INTRADETRUSORIALI DI TOSSINA BOTULINICA A MIGLIORANO LA
FUNZIONE SESSUALE NELLE PAZIENTI AFFETTE DA IPERATTIVITà DETRUSORIALE
NEUROGENA
MIRABEGRON NEL TRATTAMENTO DELLA VESCICA IPERATTIVA NEUROLOGICA :
RISULTATI PRELIMINARI
M. Gubbiotti, J. Rossi d. Vermandois, S. Proietti, M. Porena, A. Giannantoni (Perugia)
Scopo del lavoro
Attualmente è ben conosciuto il ruolo delle infiltrazioni intradetrusoriali di onabotulino tossina A (onabot/A)
nel migliorare la sintomatologia urinaria, le disfunzioni urodinamiche e la Qualita’ di vita (QoL) nei pazienti
affetti da iperattività detrusoriale neurogena (NDO) ma non sappiamo se la neurotossina è anche in grado
di apportare miglioramenti nella vita sessuale di questi pazienti. Lo scopo dello studio è stato valutare
l’efficacia della terapia con onabot/A nel trattamento dei sintomi urinari e delle disfunzioni sessuali in
pazienti affetti da NDO.
Materiali e metodi
Sono state arruolate in questo studio prospettico 18 donne affette da NDO e urge incontinence, 15 con
Sclerosi Multipla(SM) e 3 con malattia di Parkinson (PD). L’età media±SD era di 51.33±15.4 anni e la
durata media di malattia era di 11.22±7.7 anni. Dopo una valutazione basale, che includeva un diario
minzionale di 3 giorni, l’esame urodinamico ed il questionario standardizzato “Female Index of Sexual
Function”(FSFI), le pazienti sono state sottoposte ad infiltrazione intradetrusoriale di onabot/A (100 U
diluite in 10 ml di soluzione fisiologica), eseguita mediante cistoscopia ed includente il trigono. Il diario
minzionale di 3 giorni, l’esame urodinamico ed il questionario FSFI sono stati ripetuti dopo tre mesi dal
trattamento e confrontati con i risultati della valutazione basale. L’analisi statistica è stata eseguita mediante
il test di Wilcoxon.
Risultati
Dopo tre mesi dal trattamento si è osservata una significativa riduzione della frequenza minzionale media
diurna (da 10.34±4.4 al basale a 6.7±2.9,p
Discussione
L’incontinenza urinaria da urgenza (IUU), comporta gravi problematiche in molti aspetti della vita
quotidiana, inclusa l’attività sessuale. I nostri risultati dimostrano che le infiltrazioni di onabot/A, nelle
pazienti affette da patologie neurologiche, apportano un significativo miglioramento nella sintomatologia
urinaria ed eliminano l’IUU conducendo a notevoli cambiamenti in molti aspetti della loro vita sessuale.
Questi risultati, peraltro mai dimostrati fino ad ora, apportano nuove notizie inerenti la neurotossina e sul suo
ruolo nel trattamento dei pazienti con vescica neurologica e con disfunzioni sessuali.
Conclusioni
Possiamo affermare che l’impiego di onabot/A intravescicale è in grado di migliorare non solo i disturbi
urinari ma anche la vita sessuale nelle pazienti con SM.
O. RISI, E. ANDRETTA, A. MANFREDI, L. CITO (TREVIGLIO)
Scopo del lavoro
La vescica iperattiva ( OAB ) è un disturbo della fase di riempimento della vescica , caratterizzata da sintomi
di urgenza,frequenza urinaria e nicturia con o senza incontinenza da urgenza. La Farmacoterapia attuale
dell’OAB è costituita principalmente da antimuscarinici, che possono produrre effetti collaterali come
secchezza delle fauci, costipazione e visione offuscata., con risposta insufficiente, in grado di produrre bassa
compliance con la terapia antimuscarinici. Mirabegron è un selettivo β3 - agonista, il sottotipo β3 è stato
identificato in vescica liscio tessuto muscolare (muscolo detrusore).
Materiali e metodi
E’ stato condotto uno studio aperto multicentrico .I pazienti ( n = 35 ) sono stati arruolati in 2 settimane
di run - in periodo seguito da 10 settimane di di trattamento . quando il paziente ha ricevuto mirabegron
50 mg al giorno . Abbiamo valutato 35 pazienti ( 10 uomini e 25 donne ≥ 18 anni di età) che sono stati
arruolati nello studio . I pazienti che avevano diagnosi di SM da piu’ di 3 anni sono stati 27 con un
precedente trattamento con farmaci antimuscarinici con scarsa efficacia .8 pazienti presentavano una vescica
neurologica iperattiva da lesione midollare incompleta; nessuno eseguiva cateterismo intermittente. Tutti
i pazienti avevano sintomi di OAB , una frequenza di minzione in media ≥ 8 volte /24 h; ≥ 3 episodi di
urgenza ( grado 3 o 4 ) , con o senza incontinenza , durante e il periodo diario minzione 3 giorni . L’endpoint
primario il cambiamento in numero medio di episodi di minzione ogni 24 ore. Gli endpoint secondari
comprendevano variazioni di volume per minzione ; gravità di urgenza , il numero di incontinenza urinaria.
Risultati
Mirabegron 50 mg al giorno ha determinato un miglioramento statisticamente significativo medio dal
basale alla fine del trattamento (l’endpoint primario) di frequenza della minzione ( 3.1 micturitions/24 hr )
. Mirabegron ha avuto un effetto statisticamente significativo rispetto al basale per gli endpoint secondari ,
riduzioni statisticamente significative rispetto al basale alla fine del trattamento in episodi di urgenza ( 2.7) e
un aumento statisticamente significativo del volume medio svuotato per minzione (50 ml ) . La percentuale
dei pazienti classificati come “ responders” al termine del trattamento definito come un miglioramento di
almeno una categoria per la valutazione dei pazienti del beneficio del trattamento è stata del 60 % . Nessun
cambiamento nella scala EDSS nei pazienti con SM Non ci sono stati gravi eventi avversi durante la terapia.
Discussione
Mirabegron si puo’ considerare anche nei pazienti con vescica iperattiva neurologica un valida alternativa
agli antimuscarinici avendo un risultato clinico simile senza effetti collaterali tipici di questa classe di
farmaco.
Conclusioni
Mirabegron è risultato efficace e ben tollerato nei pazienti neurologici con sintomi OAB . Un ampio placebo
- studio è necessario nei pazienti neurologici per ulteriori conclusioni definitive.
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NEW APPROACH FOR QUANTITATIVE ELECTROMYOGRAPHY OF EXTERNAL URETHRAL
SPHINCTER IN PATIENTS UNDERGOING PROSTATE BIOPSY – CORRELATION WITH
URINARY SYMPTOMS AND PROSTATE MORPHOLOGY
PENETRAZIONE DELLA TOSSINA BOTULINICA IN CELLULE UROTELIALI NORMALI E
MODULAZIONE DELL’ATTIVITà SENSORIALE DELL’UROTELIO VESCICALE
M. Ferrari , F. Bianchi, G. La Croce , M. Cursi, U. Capitanio, A. Salonia, U. Del Carro , H. Danuser , A.
Mattei (Lucerna, Svizzera)
Scopo del lavoro
To investigate external urethral sphincter (EUS) activity by quantitative electromyography (EMG) assessing
potential correlations with urinary symptoms and prostate-related magnetic resonance imaging (MRI)
parameters
Materiali e metodi
58 men submitted to transrectal ultrasound-guided (TRUS) prostate biopsy had a computer-assisted EMG
[Motor Unit Potential (MUP) and Interference Pattern (IP) analysis] of EUS by transperineal approach.
Clinical data including body mass index (BMI), Charlson Comorbidity Index (CCI), ICS-male SF, IPSS,
and I-QoL questionnaires were collected for each patient; prostate volume and membranous urethral length
were measured in prostate cancer patients submitted to MRI-staging (n = 17). Linear correlation test (test di
Spearman) was used to investigate correlations between clinical variables and EUS-EMG parameters. On
the other hand regression models tested the dependence of clinical parameters on repressors IPfreq Ipamp.
Risultati
The preliminary analysis of 20 consecutive signals for each MUP and IP parameters from the right and left
EUS-side, showed in all patients no significant differences or trends and comparable results supporting the
use of the mean value. Throughout the sample, the means for MUPs parameters were: duration 6.9±1 ms,
amplitude 411.2±164.2 μV, phases 3.6±0.7, turns 2.1±0.6. For IP: amplitude/turns 308.2±71.8 μV, number of
turns/s 232.5±154.1 Hz and amplitude/turn divided by turns/s 1.4±2.1. No significant correlation emerged at
univariate analysis between EUS-EMG parameters (MUP and IP) and age, BMI, CCI, ICS-male SF, IPSS,
and I-QoL scores, MRI-derived prostate volume and membranous urethral length.
Discussione
Using a new TRUS-guided transperineal technique, the largest consecutive series of baseline male
quantitative EUS-EMG is reported.
J. Rossi de Vermandois, M. Gubbiotti, C. Amantini, V. Farfariello, S. Proietti, A. Vianello, G. Santoni, A.
Giannantoni (Perugia)
Scopo del lavoro
Recenti studi sperimentali hanno dimostrato che onabotulino tossina A (onabot/A) è capace di inibire il
rilascio di neurotrasmettitori dall’urotelio vescicale. Fino ad oggi non è stata dimostrata la presenza dei tre
recettori SV2 per la onabot/A a livello di colture uroteliali cellulari primarie e se la neurotossina sia capace
di penetrare specificatamente in queste cellule.
Materiali e metodi
Colture uroteliali cellulari normali (CUCN) sono state isolate da frammenti di vescica urinaria. La presenza
e la distribuzione dei recettori SV2 nelle CUCN sono state valutate tramite qr-PCR e Western Blot. La
penetrazione della onabot/A è stata valutata mediante citometria a flusso e microscopia a fluorescenza.
Abbiamo poi valutato l’espressione di NGF mRNA con la qr-PCR e i livelli di ATP con la bioluminescenza,
allo scopo di verificare l’attività della neurotossina dentro le CUCN.
Risultati
Il Western Blot e la qr-PCR hanno indicato la presenza di SV2-A, B e C nelle CUCN. E’ interessante notare
che l’espressione del sottotipo recettoriale SV2-C è maggiore rispetto a quella degli altri due recettori.
(Fig.1)
Discussione
L’analisi citofluorimetrica e la microscopia a fluorescenza rilevano un forte aumento di fluorescenza (colore
rosso) nella maggior parte delle cellule trattate con onabot/A. Inoltre abbiamo evidenziato che il trattamento
con la onabot/A induce una significativa up-regolazione nell’espressione del NGF mRNA e riduce
notevolmente il rilascio ed il contenuto intracellulare di ATP, rispetto ai controlli non trattati.
Conclusioni
Nelle CUCN si riscontra la presenza di tutte e tre le isoforme dei recettori SV2. Onabot/A penetra
direttamente all’interno delle cellule uroteliali e modula in maniera diretta l’espressione del NFG e la
produzione ed il rilascio dell’ATP.
Conclusioni
EMG values did not correlate with age, BMI, CCI, ICS-male SF, IPSS and I-QoL scores, MRI-estimated
prostate volume and membranous urethra length.
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RASAGILINA NEL TRATTAMENTO DEI SINTOMI DEL BASSO APPARATO URINARIO IN
PAZIENTI CON MALATTIA DI PARKINSON
A RETROSPECTIVE ANALYSIS OF A LARGE SERIES OF LAPAROSCOPIC PYELOPLASTY
WITH CONCOMITANT LITHOTOMY IN THE TREATMENT OF RENAL STONE-ASSOCIATED
UPJO.
E. Finazzi Agrò, S. Musco, A. D’Amico, V. Iacovelli, C. Perugia, G. Vespasiani, L. Brusa (Roma)
Scopo del lavoro
I pazienti affetti da malattia di Parkinson (MP) riportano frequentemente (60%) sintomi del basso
tratto urinario (LUTS) della fase di riempimento come nicturia, urgenza, aumentata frequenza diurna e
incontinenza urinaria. La dopamina sembra giocare un ruolo centrale nella patogenesi di tali affezioni.
La Rasagilina, un inibitore delle monoamino-ossidasi (MAO) di nuova generazione, può migliorare la
disponibilità sinaptica di dopamina attraverso un aumento endogeno di tale neurotrasmettitore. Il nostro
studio è volto a determinare gli effetti della Rasagilina sui LUTS in un gruppo di pazienti con MP iniziale
affetti da LUTS di riempimento.
Materiali e metodi
Pazienti affetti da MP idiopatico sono stati arruolati nello studio. I criteri di inclusione erano: presenza di
LUTS della fase di riempimento; pazienti con MP iniziale e lieve con Hoehn e Yahr score
Risultati
Venti pazienti sono stati arruolati. La somministrazione di Rasagilina ha significativamente migliorato i
parametri volumetrici vescicali in confronto allo baseline. L’analisi dei risultati ha dimostrato un incremento
significativo (p
Discussione
Nel presente studio abbiamo osservato un miglioramento clinico e urodinamico dei LUTS dopo
somministrazione di Rasagilina (rispetto allo baseline e al placebo), oltre che un trend migliorativo sui
sintomi motori in pazienti con MP iniziale di lieve entità. Lo studio conferma precedenti dati riportati in
letteratura sia nell’animale che nell’uomo. È possibile ipotizzare che i miglioramenti osservati sulla funzione
vescicale in seguito ad assunzione di Rasagilina siano da correlare a un incremento dei livelli di dopamina a
livello della porzione anteriore della corteccia del giro del cingolo e a livello dell’insula laddove precedenti
studi di imaging hanno dimostrato un’elevata concentrazione di recettori D1 dopaminergici.
Conclusioni
I nostri dati dimostrano un miglioramento significativo della funzione vescicale in pazienti trattati con
Rasagilina. I dati sono allineati con il miglioramento sui LUTS nei pazienti con MP trattati adeguatamente
con L-Dopa.
26
L. Pucci, M. Fedelini, P. Verze, G. Battaglia, M. Rubino, F. Monaco, C. Maccariello, P. Fedelini, V. Mirone
(Napoli)
Scopo del lavoro
Ureteropelvic junction (UPJ) obstruction is the most common congenital abnormality of the ureter, with an
annual incidence of 5/100.000 population. The presence of a concomitant stone is observed in a percentage
of cases ranging 20-70%. We retrospectively reviewed our series of consecutive laparoscopic pyeloplasty
(LP) with simultaneous lithotomy over a 10 year period.
Materiali e metodi
A series of 275 consecutive cases of LP performed over a period of 10 years (May 2004/December 2013)
was retrospectively evaluated and final analysis included 26 patients with a concomitant renal stone.
The following methods were used for stone extraction: 1. Extraction with rigid forceps (grasper) directly
introduced into the trocar; 2. Extraction by continuous washing of the pelvis and calyces with saline solution
and suction; 3. Extraction using a flexible nephroscope inserted through a small pelvic incision.
Risultati
Mean operative time was 116.5 minutes (range 65-360 min). The mean blood loss was 20 mL (range
5-500 mL), and no blood transfusions were necessary. The mean postoperative hospital stay was 4.2 days
(range 3-14 days). Mean stone size of 3.4 cm (range 0.8 to 6.5); in 17 cases stones were removed at the same
time of LP (14 were localized in the renal pelvis, 3 were calyceal). In 2 cases of pelvic localization and 7
cases of calyceal position, stones
Discussione
The surgical treatment of UPJ obstruction associated with renal stones is still controversial and has
undergone significant changes in recent years. Previously published series showed that although LP is a
technically challenging procedure, concomitant pyelolithotomy can be performed safely. In our experience
a simultaneous LP with lithotomy appears feasible and effective when a single, large pelvic stone is present,
while it results more challenging in case of multiple calyceal stones.
Conclusioni
LP with concomitant lithotomy is a feasible and safe procedure in particular in presence of a single, large
pelvic stone. In case of multiple calyceal stones the procedure is more demanding and the use of a flexible
nephroscope is warranted.
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CALCOLOSI ASSOCIATA AD ANOMALIE DELLA VIA ESCRETRICE: TRATTAMENTO
ENDOUROLOGICO
CALCOLOSI DI CARBONATO DI CALCIO E URATICA: DIFFERENZIAZIONE IN BASE A
UN’ANALISI TC
L. Bettin, P. Beltrami, A. Guttilla, V. Palumbo, L. Meggiato, A. Iannetti, A. Morlacco, F. Zattoni (Padova)
M. Delor, F. Longo, P. Bernardini, A. Del Nero, E. Montanari (Milano)
Scopo del lavoro
Le anomalie di posizione e di fusione del rene sono dovute ad un’alterata embriogenesi delle vie urinarie
con conseguente particolare morfologia della via escretrice che può determinare stasi urinaria e formazione
di calcoli, spesso recidivanti. Diventa pertanto fondamentale scegliere il trattamento più efficace e meno
invasivo: in questo scenario la litotrissia ureterorenoscopica retrograda (RIRS) trova ampi spazi ed
indicazioni. Riportiamo la nostra esperienza di questi ultimi 2 anni nel trattamento endourologico della litiasi
in soggetti affetti da anomalie della via escretrice.
Scopo del lavoro
Scopo dello studio è stato valutare se alla Tomografia Computerizzata (TC) sia possibile distinguere la
calcolosi di carbonato di calcio (CC) da quella di acido urico (UA).
Materiali e metodi
Dal Maggio 2012 al Febbraio 2014 sono stati reclutati 9 pazienti: 7 maschi (una ectopia pelvica, 5 reni
a ferro di cavallo e un rene sigmoideo) e 2 femmine con anomalie di posizione (ectopia crociata con
malrotazione in un caso, ectopia pelvica nell’altro) di età media di 51 anni, sottoposti a trattamento
endourologico per calcolosi. Le dimensioni dei calcoli trattati variavano da 10 a 80 mm (media 27.6 mm).
In un caso si trattava di calcolosi renoureterale e 2 pazienti affetti da rene a ferro di cavallo presentavano
una litiasi bilaterale (11 assi trattati). Eccetto un caso di calcolosi a stampo, le formazioni litiasiche erano
localizzate in ampolla renale (4 casi), nei calici medi (2 casi), nei calici inferiori (1 caso) e multipli (3
casi). Tutti i pazienti sono stati valutati con imaging con mezzo di contrasto in quanto proprio in questi
casi riteniamo imperativa la visualizzazione della morfologia della via escretrice in modo da pianificare il
trattamento più opportuno. Sono state eseguite complessivamente 17 procedure, di cui 15 RIRS e 2 litotrissie
percutanee (PCNL).
Risultati
Considerando il trattamento per via retrograda abbiamo ottenuto la bonifica completa in 10/15 casi alla
prima seduta. Considerando i calcoli di dimensioni inferiori a 20 mm la RIRS è stata risolutiva con una
procedura nel 100% dei casi. Per quanto riguarda la PCNL, in un paziente si è ottenuta la bonifica completa
con una singola procedura mentre nel secondo caso è stata effettuata una RIRS di completamento. Non sono
state registrate complicanze maggiori intra o postoperatorie.
Discussione
Il trattamento endourologico della calcolosi in pazienti affetti da anomalie anatomiche della via escretrice
presenta problematiche diverse rispetto al trattamento della calcolosi in reni normali. Le dimensioni e la
localizzazione intrarenale dei calcoli non sempre rappresentano il fattore principale per porre l’indicazione
al tipo di procedura. Talvolta infatti la PCNL presenta difficoltà nella creazione dell’accesso o rischi di
complicanze maggiori. La RIRS è una procedura efficace, sicura e mini-invasiva, spesso di scelta in questi
soggetti anche per l’elevata probabilità di recidiva.
Conclusioni
Riteniamo che i pazienti con calcolosi associata ad anomalie della via escretrice possano più degli altri
beneficiare di un trattamento retrogrado in virtù degli alti tassi di successo con una relativamente ridotta
incidenza di complicanze.
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Materiali e metodi
Dal gennaio 2008 al gennaio 2014 abbiamo sottoposto a PCNL 176 pazienti e tutti i calcoli sono stati
esaminati tramite spettrometria ad infrarossi (Thermo Scientific Nicolet iS10). Nel gruppo considerato
i calcoli di carbonato di calcio e di acido urico (componente principale del calcolo > del 70%) erano
rappresentati nel 16% dei casi (28/176). Sono state esaminate le TC dei 28 pazienti registrando per ogni
calcolo larghezza (D), area (A), volume (V), valore Hounsfield del centro (HUC) e della periferia (HUP) del
calcolo, variazione del valore Hounsfield tra centro e periferia (HUV). E’ stata quindi calcolata la Hounsfield
density (HUD) definita come il rapporto tra valore HU al centro e larghezza massima (D) del calcolo.
All’esame spettrometrico 10 pazienti erano portatori di calcoli di AU e 18 di CC.
Risultati
In tabella sono riportate le medie generali della popolazione esaminata e le medie specifiche per AU e CC di
D, A, V, HUC, HUP, HUV ed HUD. Abbiamo quindi confrontato le medie generali e specifiche per valutare
se esistessero differenze statisticamente significative tra i calcoli di AU ed di CC per ciò che riguarda le
caratteristiche TC e l’analisi statistica è stata eseguita tramite test Chi-quadro e T-test. La differenza tra le
medie generali e la composizione del calcolo sono risultate essere statisticamente significative per tutte le
variabili con p rispettivamente
Discussione
I calcoli di AU e di CC risultano differenti per valutazione TC e distinguibili quando essi siano puri :
infatti i calcoli di CC appaiono avere alla TC valori HU più elevati sia al centro che alla periferia ed inoltre
presentano una maggiore variabilità di densità tra centro e periferia risultando meno omogenei rispetto alla
calcolosi di AU come confermato dalla differenza di HUV e HUD tra i due gruppi.
Conclusioni
La TC preoperatoria è considerata essenziale nella corretta indicazione e pianificazione degli interventi
di litotrissia extra ed intracorporea. L’attento esame di alcune caratteristiche radiologiche della litiasi
unitamente alla valutazione di dati anamnestici e di semplici esami di laboratorio può predire in modo
corretto la composizione del calcolo. Il nostro lavoro dimostra come sia possibile distinguere i calcoli di
carbonato di calcio da quelli di acido urico e quindi calcoli duri poco sensibili a terapia medica da calcoli
relativamente friabili più sensibili a terapia medica. Queste informazioni - limitatamente ai calcoli “puri”possono essere utili nella pianificazione dell’intervento, della scelta dell’energia da impiegare in litotrissia e
della strategia post operatoria.
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P 30
P 31
EFFICACY OF SILODOSIN VS. TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY FOR
LOWER URETERAL STONES: OUR EXPERIENCE
ENDOSCOPIC COMBINED INTRA RENAL SURGERY: ANALISI DELLA LEARNING CURVE
L. DELL’ATTI, C. Ippolito, S. Papa, G. Ughi, G. Capparelli, G. Daniele, L. Fornasari, G. Russo (Cona)
Scopo del lavoro
Medical expulsive therapy using α-adrenoceptor antagonists has recently emerged as an alternative strategy
for the initial management of small distal ureteral stones. The aim of this study was to compare the safety
and efficacy of tamsulosin (0.4mg) vs. silodosin (8mg) as a medical expulsive therapy for distal ureteral
stones.
Materiali e metodi
In this prospective randomized study, between May 2012 and December 2013, 136 consecutive patients
(pt) with only one single lower ureteral stone, (4-10mm size) arrived at our Department of Urology. For
a 3-weeks period, 68 pt per group were assigned to the following treatments: Group A(GA) received
tamsulosin 0.4mg once daily, and Group B(GB) received silodosin 8mg once daily. Exclusion criteria
included pt having severe hydronephrosis, urinary tract infection, fever, bilateral ureteral stones, a solitary
kidney, an extra stone in the upper urinary system, a previous surgical history on the ipsilateral ureter, or
diseases such as diabetes, hypertension, pregnancy and renal insufficiency.
Risultati
Among the 136 patients enrolled, one pt in GA and two pt in GB were unable to continue the study
because of orthostatic hypotension within a week from commencing treatment; consequently a total of 133
patients (GA:67;GB:66) were included in this study. The mean stone size was 5.37±1.33mm for GA and
5.82±1.66mm for GB. No statistically difference was shown in terms of age, sex, side of stone and stone size
between the two groups. A stone expulsion rate of 61.2% (41 out of 67 patients) was observed in GA and
80.3% (53 out of 66) was observed in GB. GB showed a statistically advantage in terms of stone expulsion
rate (p:0.003). GB showed also a statistically significant advantage in terms of expulsion time (weeks)
(p:0.002). Four pt (10.2%;4/39) in GA and ten pt (22.7%;10/44) in GB recorded retrograde ejaculation (
Discussione
Silodosin has a lower incidence of ureteral colic during treatment and a lower incidence of requiring
auxiliary procedures after treatment. Limitations of the present study include the absence of a placebo
control group and not evaluating the stone expulsion percentage between men and women. Since our
primary end-point was stone passage rates, which was an objective outcome based on imaging studies, the
bias due to the absence of a placebo control might be minimal.
Conclusioni
Silodosin 8mg vs. tamsulosin 0.4mg shows a significant increase in expulsion rate and a decrease in
expulsion time of lower ureteral stones in our study, but this needs to be studied further in adequately
powered clinical trials.
M. Cossu, M. Poggio, C. Fiori, M. Manfredi, N. Serra, R. Bertolo, D. Garrou, G. Cattaneo, D. Amparore, R.
Aimar, R. Scarpa, F. Porpiglia (Orbassano )
Scopo del lavoro
La nefrolitotomia percutanea (PCNL), è il trattamento di scelta per la calcolosi renale voluminosa e/o
complessa e la Endoscopic Combined Intra Renal Surgery (ECIRS) con il paziente in posizione supina
rappresenta una valida alternativa alla PCNL standard con il paziente prono. In letteratura, il raggiungimento
della learning curve per questo tipo di procedura, ovvero il numero di procedure che il chirurgo deve
effettuare per essere in grado di eseguirle in maniera completamente indipendente con outcomes
“ragionevoli”, si ottiene dopo 60 casi, mentre l’eccellenza dopo 1001. Scopo del lavoro è presentare la
nostra esperienza riguardo al completamento della learning curve per ECIRS di un unico operatore.
Materiali e metodi
Sono stati estratti dal nostro database (mantenuto prospetticamente) i dati relativi ai pazienti sottoposti a
ECIRS da gennaio 2011 a dicembre 2013. Le procedure sono state eseguite da un unico primo operatore
(M.C.), con una pregressa esperienza di 113 procedure eseguite come aiuto e 9 procedure (o tempi di
procedura) eseguite come primo operatore “tutorato” nel periodo compreso tra 1997-2010. I pazienti sono
stati suddivisi in tre gruppi sulla base del criterio cronologico: G1 (#1-35); G2 (#35-70); G3 (#70-107).
Per ciascun gruppo sono state analizzate e confrontate le variabili demografiche, relative ai calcoli e perioperatorie e la percentuale di stone-free definita come assenza di frammenti residui significativi (>3mm) ai
controlli (eco e radiologici) a tre mesi dal trattamento. Le complicanze postoperatorie sono state classificate
secondo il sistema di Clavien. L’ analisi statistica è stata eseguita mediante test chi quadro e test ANOVA di
Kruskal Wallis su STAT Soft 6©, con significatività statistica fissata per p<0.05.
Risultati
Sono stati analizzati i dati di 107 pazienti trattati consecutivamente presso la nostra Divisione e suddivisi
in 3 gruppi. I gruppi risultavano sovrapponibili per età, BMI, ASA score, numero, diametro e distribuzione
dei calcoli (p>0.05). I tempi operatori sono stati di 114(+54) min per il G1, 107.4(+46) min per il G2 e
84.3(+36) min per il G3, con una differenza significativa tra G1 e G3 (p=0.034) e tra G2 e G3 (p=0.04).
La stone-free rate dopo singolo trattamento è risultata pari a 83% per G1, 78% per G2 e 96% per G3,
registrando una differenza significativa per G1 vs G3 e G2 vs G3 (rispettivamente, p=0.024 e p=0.011). La
durata media del ricovero è stata rispettivamente di 5.8(+1.7), 5.9(+1.9) e 4.9(+0.9) giorni (p>0.05). Il tasso
di complicanze di grado > III è risultato pari allo 0% in tutti i gruppi.
Discussione
Grazie alla esperienza come aiuto e primo operatore “tutorato” i risultati della ECIRS sembrano essere
“ragionevoli” anche nella fase iniziale della curva di apprendimento. I risultati perioperatori e la stone-free
rate migliorano in modo significativo dopo circa 60 procedure.
Conclusioni
Nella nostra esperienza 60 procedure sembrano rappresentare un ragionevole cut-off per considerare
completata la curva di apprendimento della ECIRS.
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P 32
P 33
ENDOSCOPIC COMBINED INTRA RENAL SURGERY: QUAL è L’IMPATTO DEL TEMPO
RETROGRADO?
IMPACT OF SURGICAL EXPERIENCE ON SAFETY AND EFFICIENCY OF RIRS FOR KIDNEY
STONES
M. Cossu, M. Poggio, C. Fiori, M. Manfredi, R. Bertolo, N. Serra, S. Grande, F. Porpiglia (Orbassano)
F. Berardinelli, L. Cindolo, S. Proietti, O. Dalpiaz, D. Hennessey, F. Neri, F. Pellegrini, F. Tamburro, L.
Schips, G. Giusti (Vasto)
Scopo del lavoro
Combinando l’approccio anterogrado e retrogrado alle cavità renali, la endoscopic combined intrarenal
surgery (ECIRS) permette l’utilizzo di ureteroscopi rigidi e flessibili; la valutazione preliminare delle
caratteristiche del calcolo, il risparmio di molteplici accessi percutanei, il trattamento di concomitante
ureterolitiasi, il controllo finale dello stone-free status. Inoltre la tecnica di puntura endovision permette
l’accesso sotto visione diretta alle cavità renali, Scopo del lavoro è presentare i risultati della ECIRS nel
nostro centro con particolare attenzione ai dati relativi all’utilità dell’approccio retrogrado.
Materiali e metodi
Sono stati estratti dal nostro database i dati relativi ai pazienti sottoposti a ECIRS da febbraio 2011 a
dicembre 2013. I pazienti sono stati trattati in posizione di Valdivia modificata Galdakao, da un singolo
chirurgo. Quando possibile l’accesso alla via escretrice è stato condotto mediante tecnica endovision-. Sono
state valutate le caratteristiche demografiche dei pazienti, le caratteristiche dei calcoli, i dati perioperatori
e la percentuale di stone-free. Le complicanze postoperatorie sono state classificate secondo il sistema di
Clavien. Sono stati inoltre valutati i dati relativi all’accesso retrogrado ed alla puntura endovision.
Risultati
Sono stati analizzati i dati di 107 pazienti (eta media 52 aa) trattati presso la nostra Divisione. Le
caratteristiche dei calcoli erano le seguenti: diametro medio 22,6 mm, calcolosi multipla: 55.1%, litiasi
ureterale associata: 18.7%. La sede è risultava: calice superiore 33%, medio 28%, inferiore 63%, pelvi 72%.
L’approccio retrogrado è stato possibile in 94(89.5%) casi, impossibile in 13 casi per calcolosi a stampo
con impossibilità alla visione dei calici (8), anomalie anatomiche (2), kinking ureterali e stenosi del GPU
(3). L’utilità del tempo retrogrado ha riguardato; nel 47.3% la corretta localizzazione del calcolo renale e
la scelta del calice per l’accesso; nel 18.7% il trattamento di calcolo ureterale, nel 18.9% il controllo delle
cavità renali post-procedura. La puntura endovision è stata eseguita nel 70% dei casi, la mediana di tentativi
di puntura percutanea è stata di 2(1-5). Il tempo operatorio è stato di 101.6min. La percentuale di risultato
pazienti stone-free dopo il singolo trattamento è risultata pari all’85%. Non sono state registrate significative
complicanze intraoperatorie. Il tasso di complicanze post operatorie di grado>III è risultato pari all’1.9%,
nessuna complicanza intra o post operatoria è stata registrata in seguito all’utilizzo combinato della tecnica
retrograda.
Aim of the study
The management of kidney stones has improved dramatically over the years, with endoscopic techniques
such as retrograde intrarenal surgery (RIRS) constituting a large portion of the therapeutic procedures. The
aim of this study was to compare the safety and the results of this technique between stone centers with
urologists with different experience.
From March 2010 to August 2013, we conducted a prospective study including all RIRS performed for
kidney stones in 4 European centers. We divided the cases in two groups. Group 1: cases operated by one
surgeon at the top of his learning curve (>400 RIRS); Group 2: cases operated by three surgeons in the early
phase of learning curve (
Results
Three hundred and fifty-one patients underwent 367 RIRS with holmium laser lithotripsy for renal stones.
Group 1 included 216 procedures while Group 2 included 151. Both groups were similar for patient’s
demographics (age:54vs53yr, BMI: 26vs27 Kg/m2), stone length (12,6vs13mm). Technical aspects of
the procedures were similar in both groups (operative time: 54vs74min; use of ureteral access sheath:
74%vs86%). The operative time and the stone length represented a good predictors of favorable clinical
outcomes (SFR) independently of the groups at multivariate analysis (OR 0.989; 95% CI 0.981-0.998, p
Discussion
The RIRS is a minimally invasive procedure and it is very practiced by young surgeons, with good results
in terms of stone-free rate compared to ESWL and with low complications rate compared to PCNL.
Nevertheless, to obtain good results in terms of efficacy and safety a great deal of experience is required.
This study confirms that the most experience in RIRS is necessary in order to achieve a lower complications
rate. Also the young urologist could obtain optimal results in term of SFR.
Conclusions
Although the RIRS is a technique with a short learning curve, a long experience is necessary for optimal
results. Skilled surgeons have lower complications rate.
Discussione
A nostro avviso l’accesso retrogrado contribuisce significativamente al conseguimento dei positivi risultati.
La tecnica di puntura endovision rappresenta infine un “valore aggiunto” di questa procedura.
Conclusioni
I dati della nostra casistica confermano che la ECIRS è una tecnica fattibile, sicura ed efficace.
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P 34
P 35
L’ANATOMIA DEL CALICE INFLUENZA L’ESITO DELL’URETEROSCOPIA FLESSIBILE
INTRARENALE (RIRS) IN PAZIENTI CON CALCOLOSI PIELO-CALICEALE?
LA CLASSIFICAZIONE DI CLAVIEN NELLA SEGNALAZIONE DELLE COMPLICANZE
INFETTIVE POST-RIRS: STUDIO EUROPEO MULTICENTRICO PROSPETTICO
L. D’Arrigo, F. Savoca, A. Costa, A. Bonaccorsi, M. Pennisi, F. Aragona (Catania)
F. Berardinelli, L. Cindolo, S. Proietti, O. Dalpiaz, D. Hennessey, F. Neri, F. Pellegrini, F. Tamburro, G.
Giusti, L. Schips (Vasto)
Scopo del lavoro
Valutare quali parametri preoperatori influenzano l’esito della RIRS ai fini dello stone free (SF) ed analizzare
i fattori che favoriscono l’insorgenza di sepsi.
Materiali e metodi
Tra Giugno 2011 al Dicembre 2013 sono stati sottoposti a RIRS 132 pazienti con calcolosi renale, in 73
era presente una calcolosi caliceale singola o associata. Sono stati rilevati i dati anagrafici e mediante
URO-TC, il diametro, l’area, il volume, la densità del calcolo, il numero dei calcoli, il calibro e la
lunghezza dell’infundibulo, l’angolo infundibulo-pielico, lo stone free rate, i tempi operatori, la presenza di
nefrostomia o double J valutandone anche l’influenza sull’insorgenza di febbre persistente o sepsi. I pazienti
sono stati sottoposti a profilassi/terapia antibiotica preoperatoria e trattati con l’ausilio di camicia ureterale.
In presenza di più calcoli, il diametro, il volume e l’area sono stati calcolati come somma dei singoli valori.
Sono stati definiti stone free pazienti privi di calcoli a 3 mesi dal trattamento. L’analisi statistica è stata
condotta con software R.
Risultati
Lo stone free rate è stato del 77,7% dopo un primo trattamento e dell’86,9% dopo il secondo.
Dall’analisi statistica è emerso che il diametro (p=0,0006) e la superfice (p=0,050) del calcolo correlano
significativamente con l’esito del trattamento mentre la lunghezza (p= 0,1826) la larghezza (p=0,2169) e
l’angolazione del calice (p=0,5559) così come il volume (p=0,3573) e la densità (p=0,7784) sono ininfluenti
ai fini dello SF. Il tempo operatorio è stato inferiore nel gruppo di pazienti che erano SF (p=0,0003). La
calcolosi in più sedi (p=0,006) influenza significativamente l’esito del trattamento; il tempo operatorio è
correlato con le dimensioni del calcolo (p=0,0002). Dall’analisi delle complicanze è emerso che tempo
operatorio (p=0,1909), volume (p=0,9597), diametro (p=0,6789) e area (p=0,2126) non influenzano
l’insorgenza di stati settici diversamente dalla derivazione urinaria. La presenza di stent preoperatorio
favorirebbe la successiva comparsa di febbre (p=0,01548). Il 19,6% ha sviluppato febbre post-operatoria per
più di 48 ore. Abbiamo inoltre riscontrato 2 stenosi ureterali ed 1 ematoma perirenale.
Discussione
Il diametro e l’area del calcolo sono parametri in grado di predire l’esito del trattamento ma l’anatomia
del calice, a differenza da quanto riportato in letteratura, non influenza lo stone free rate del paziente. La
presenza di una calcolosi multipla influisce negativamente sullo SF. Le infezioni post-operatorie nonostante
la profilassi o la terapia antibiotica preoperatoria sembrano essere favorite, in modo significativo, dalla
presenza di stent preoperatorio e non dalla durata dell’intervento e dalle dimensioni del calcolo.
Conclusioni
Un’attenta valutazione preoperatoria di questi parametri può permette di pianificare meglio la strategia
chirurgica al fine di migliorare lo stone free rate e ridurre l’incidenza di complicanze.
34
Scopo del lavoro
L’ureterorenoscopia flessibile (RIRS) è ampiamente utilizzata per il trattamento dei calcoli renali.
Nonostante l’uso di antibiotici e della guaina di accesso ureterale (UAS), in grado di diminuire la probabilità
di reflusso pielolinfatico e pielovenoso, il rischio di infezione sistemiche, talvolta gravi, nel postoperatorio
non è trascurabile. Il tasso discordante di complicanze infettive riportato nelle varie serie di RIRS è dovuto
in parte ad errori di segnalazione, in parte a classificazioni non standardizzate. Scopo di questo lavoro è
descrivere il rischio di complicanze infettive delle RIRS per calcoli renali utilizzando la classificazione
standardizzata secondo Clavien.
Materiali e metodi
Tra Agosto 2010 a Marzo 2013, sono stati inclusi prospetticamente i pazienti di 4 centri urologici Europei
sottoposti a RIRS per calcoli renali. Informazioni demografiche, peri e post-peratorie e le complicanze
infettive sono state raccolte e classificate utilizzando la classificazione standardizzata secondo Clavien
riportata in Tabella 1.
Risultati
Sono stati arruolati 351 pazienti, per un totale di 367 RIRS. 14 pazienti hanno richiesto una seconda
procedure e 2 pazienti tre procedure per ottenere lo stato di stone-free. In tutti i pazienti è stata
somministrata una terapia antibiotica peri e postoperatoria. La UAS è stata posizionata in 293 procedure
(80%). In 30 pazienti (8%) si è verificata una complicanza post-operatoria tra queste 27 erano di tipo
infettivo: 22 pazienti (73%) hanno avuto febbre (Grado I) e 3 pts (10%) una pielonefrite non-ostruttiva (
Grado II) tutte trattate conservativamente. In 2 pts (7%) si è verificata una pielonefrite ostruttiva (Grado III)
che ha richiesto il posizionamento di un catetere ureterale JJ. Le complicanze si sono verificate in I, II e III
giornata post-operatoria rispettivamente in 18 pts (67%), in 3 pts (13%), e in 6 pts ( 20%).
Discussione
Anche se numerose serie di RIRS hanno riportato i tassi di complicanze infettive, nessun consenso è
stato ancora raggiunto su come definire e stratificare le complicanze in base alla loro gravità. Diverse
classificazioni sono state riportate, utilizzando terminologie diverse, rendendo difficile il confronto dei
risultati. L’utilizzo della classificazione di Clavien per le complicanze infettive post-RIRS ha reso l’analisi
dei risultati oggettiva e riproducibile anche in uno studio multicentrico.
Conclusioni
A nostro giudizio è un sistema facile da eseguire e il suo impiego dovrebbe entrare nella valutazione
quotidiana delle complicanze della RIRS.
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P 36
P 37
LA PCNL “TUBELESS” NON è UN AZZARDO
NEFROLITOTRISSIA PER VIA URETERORENOSCOPICA RETROGRADA (RIRS) PER IL
TRATTAMENTO DI CALCOLI RENALI TRA 2 E 3 CM DI DIAMETRO
R. Peschechera, S. Proietti, G. Sortino, G. Taverna, G. Giusti (Rozzano )
Scopo del lavoro
Recentemente, il CROES ha riclassificato le complicanze della PCNL secondo il sistema di Clavien-Dindo,
migliorando l’accuratezza nel riportare gli eventi avversi correlati a tale procedura. Molti studi hanno
dimostrato che non ci sono differenze in termini di efficacia e sicurezza fra la nefrolitotrissia percutanea
“tubeless” (t-PCNL) e la PCNL standard (s-PCNL), ma nessuno di essi ha mai utilizzato la sovracitata
classificazione per comparare le complicanze di tali procedure. Scopo dello studio è stato quello di
riclassificare e confrontare le complicanze della nostra serie di t-PCNL e s-PCNL in accordo con questa
nuova validazione del sistema di Clavien-Dindo.
Materiali e metodi
Retrospettivamente, sono state incluse nello studio 652 PCNL, 354 s-PCNL e 298 t-PCNL. Le complicanze
sono state riclassificate secondo la validazione CROES per la PCNL del Clavien score. Sono stati inoltre
valutati il dolore postoperatorio tramite la scala analogica visiva (VAS), la necessità di analgesia postoperatoria e i tempi di ospedalizzazione.
Risultati
Le caratteristiche demografiche dei pazienti e quelle relative alla calcolosi sono illustrate in tabella 1.Le
complicanze riclassificate secondo il sistema di Clavien modificato sec Dindo sono riportate nella Tabella
2.L’ospedalizzazione media è stata significativamente più breve nel gruppo della t-PCNL (2.2±0.5 vs
5.3±1.6; P < 0.01). La richiesta media di analgesici per il gruppo s-PCNL è stata significativamente più alta
rispetto a quella del gruppo t-PCNL (P < 0.01).
Discussione
I pazienti sottoposti a t-PCNL hanno riportato un tasso di complicanze di Grado I significativamente
più basso rispetto a quelli della s-PCNL. Nella maggior parte dei casi, il Grado I è dovuto alla richiesta
di analgesici. Questo dato concorda con le precedenti evidenze in letteratura in cui viene sottolineato il
ruolo della nefrostomia quale principale causa del dolore postoperatorio. La t-PCNL andrebbe quindi
considerata non un azzardo ma la naturale conclusione di una PCNL priva di complicanze intraoperatorie.
L’inquadramento delle complicanze secondo il Clavien score consente di standardizzare e migliorare
l’accuratezza nel riportare gli effetti avversi della PCNL. Riteniamo pertanto che tale sistema debba essere
universalmente adottato per migliorare l’affidabilità della letteratura scientifica urologica.
Conclusioni
La t-PCNL tubeless è una procedura sicura ed efficace, anche in confronto con la s-PCNL.
S. Proietti, R. Peschechera, G. Sortino, G. Taverna, G. Giusti (Milano)
Scopo del lavoro
La RIRS sembra essere una valida alternativa alla nefrolitotrissia percutanea(PCNL) nel trattamento della
calcolosi renale fino a 3cm di diametro. Al momento la maggior parte degli studi riguardanti tale argomento
sono retrospettivi. Nessuno di questi ha utilizzato come imaging pre e post-operatoria la TC addominale.
Inoltre, pochi studi hanno utilizzato il volume del calcolo come misura dello “stone burden”. Scopo di tale
studio è stato quello di valutare l’efficacia e la sicurezza della RIRS per il trattamento di calcoli renali fra 2 e
3cm di diametro.
Materiali e metodi
Da Settembre 2012 a Settembre 2013 sono stati arruolati prospettivamente tutti i pazienti sottoposti a RIRS
per litiasi renale di diametro tra 2 e 3cm. Il work-up preoperatorio e ad un mese dall’ intervento è stato
caratterizzato da: anamnesi, esame obiettivo, esame delle urine ed urinocoltura, ematocrito, creatininemia
e TC addome senza mdc. Nei pazienti con litiasi multipla, è stata effettuata la somma del diametro e del
volume dei singoli calcoli. Il volume dei calcoli è stato ricavato utilizzando la formula dell’ ellissoide
scaleno (se diametro massimo della litiasi superiore a 15mm), oblato (se diametro fra 9 e 15mm) e prolato
(diametro inferiore a 9mm). Le complicanze sono state riportate secondo la classificazione di ClavienDindo. In caso di calcolosi residua significativa post RIRS, è stato programmato un 2nd look o un 3rd look
endoscopico. L’endpoint primario è stato quello di valutare la percentuale di bonifica della litiasi urinaria;
gli endpoints secondari sono stati quelli di valutare la relazione fra volume e diametro del calcolo con la
percentuale di bonifica della litiasi urinaria,tempo operatorio,multiple procedure,tempi di ospedalizzazione e
complicanze.
Risultati
Le caratteristiche demografiche e quelle della litiasi sono riportate in tabella 1;i risultati intra e postoperatori
nella tabella 2.Correlazioni statisticamente significative sono state evidenziate tra il volume del calcolosi e la
percentuale della bonifica (p
Discussione
La RIRS è un’efficace alternativa alla PCNL per il trattamento di calcoli renali compresi fra 2 e 3cm di
diametro. Il tasso di complicanze è basso ed il tempo di ospedalizzazione breve.Inoltre è da sottolineare
come il volume del calcolo debba essere adottato come misura dello stone burden perché in tale studio
correla con il tasso di bonifica della litiasi urinaria. Questo può consentire una più accurata pianificazione
dell’intervento e una adeguata informazione del paziente riguardo la possibilità di sottoporsi a multiple
procedure per ottenere una completa bonifica della litiasi urinaria.
Conclusioni
La RIRS risulta essere una procedura efficace e sicura per il trattamento di calcoli urinari compresi tra 2 e 3
cm di diametro.
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P 38
P 39
RIRS VS PCNL NEL TRATTAMENTO DELLA CALCOLOSI RENALE >2 CM: NOSTRA
ESPERIENZA.
RUOLO DELLA PCR COME NUOVO INDICE PREDITTIVO DI ESPULSIONE SPONTANEA DI
CALCOLI. DATI PRELIMINARI.
P. Castellan, M. Marchioni, P. De Francesco, R. Castellucci, M. Ingrosso, R. Manco, M. Campanelli, M.
Nicolai, A. Zezza, R. Tenaglia (Chieti)
C. Micheli, G. Manasse, A. Pietropaolo, H. Nikaj, E. Salvini, V. Bini, P. Guiggi (perugia)
Scopo del lavoro
Recentemente le linee guida europee raccomandano la RIRS (Retrograde Intrarenal Surgery) come valida
alternativa alla PCNL (Percuteneous Nephrolithotomy) nel trattamento chirurgico della calcolosi renale
>2cm. Scopo dello studio è comparare le due procedure valutandone lo stone free rate (SFR) e la morbidità.
Materiali e metodi
Da Marzo 2013 a marzo 2014 abbiamo selezionato 45 pazienti affetti da calcolosi renale >2cm : 25
sottoposti a RIRS e 20 a PCNL. Nella calcolosi multipla si è calcolata la somma delle misure dei singoli
calcoli. E’ stato considerato stone free rate (SFR) il paziente con residui di calcoli <0,05.
Risultati
La percentuale di SFR dopo una procedura è del 60% e del 90 % per RIRS e PCNL, rispettivamente
(P=0.015). Lo SFR aumenta al 92% dopo la seconda procedura di RIRS. La durata media dell’intervento è
80(±) 20 min nel gruppo RIRS ma 140 (±) 30 min nel gruppo PCNL (P
Discussione
Grazie ai continui miglioramenti tecnologici, ad oggi la RIRS offre risultati soddisfacenti anche nel
trattamento di calcoli renali >2cm. Il tasso di complicanze tra le due procedure è sovrapponibile, ma i tempi
operatori e di degenza ospedaliera sono significativamente ridotti nella RIRS, che tuttavia richiede spesso la
necessità di sottoporre il paziente ad una seconda procedura chirurgica.
Conclusioni
D’accordo con le linee guida europee, anche se la PCNL rapprestenta ancora il gold standard, la RIRS può
essere considerata trattamento di prima scelta in casi selezionati di calcolosi renale >2cm.
Scopo del lavoro
Un calcolo, che non viene eliminato, tende a creare una flogosi maggiore nel lume ureterale rispetto ad uno
soggetto ad espulsione spontanea. Obiettivo del nostro studio è valutare l’utilità della PCR come indice
predittivo di espulsione spontanea
Materiali e metodi
Sono stati arruolati pazienti affetti da litiasi unica dell’uretere distale da 3 a 8 mm (media 5,38) affetti da
colica renale, sottoposti ad ecografia e/o URO-TC. All’arrivo (giorno 0) e alla 28° giornata veniva effettuato
il dosaggio della PCR. Tutti erano sottoposti a terapia espulsiva per 28 giorni. In caso di persistenza
del calcolo, il pz era sottoposto a trattamento ESWL o URS, con ripetizione del dosaggio della PCR 10
giorni dopo. Esclusi dallo studio pazienti affetti da patologie responsabili di un innalzamento della PCR.
L’indagine statistica è stata condotta con i test:Ҳ2, Mann-Whitney, Wilcoxon Rank test.
Risultati
Sono stati valutati 69 pazienti, di età tra 25-81 anni. Il 75,36% ha riscontrato espulsione spontanea entro
28 giorni (gruppo1), il 24,64% persistenza del calcolo (gruppo2). I pazienti del gruppo 1, con litiasi media
5,02 mm, al giorno 0 avevano valori medi di PCR di 0,554 mg/dl (0-4,5) che, in 28° giornata scendeva a
0,206 mg/dl (0-2,5). In 4 pz la PCR rimaneva al di sopra del range di normalità anche dopo l’espulsione del
calcolo. I pazienti del gruppo 2, con litiasi media 6,06 mm, al giorno 0 avevano valori medi di PCR di 2,329
mg/dl (1-6,2) che, dopo 28 giorni erano aumentati a 2,829 mg/dl (1-7,2). In questi pazienti, la PCR scendeva
a valori medi di 0,421 mg/dl in 10° giornata post trattamento. All’analisi statistica i 2 gruppi risultano
omogenei per dimensione dei calcoli. La PCR è un fattore predittivo indipendente per l’espulsione spontanea
di calcoli sia misurata al giorno 0 che al giorno 28 (p<0,002)
Discussione
Una delle cause della mancata espulsione può essere, a parità di diametro,la flogosi della parete a diretto
contatto con il calcolo, indicando un possibile “impattamento” dello stesso. I pazienti che al giorno 0 hanno
valori bassi di PCR (0,554mg/dl) infatti, espellono spontaneamente i calcoli indipendentemente dalle
dimensioni; mentre per valori medi superiori (2,329mg/dl) si è dovuto procedere a trattamento.
Conclusioni
l dati preliminari del nostro studio mostrano come il valore della PCR ci può aiutare a scegliere tra una
terapia conservativa o attiva grazie alla sua capacità di predire l’espulsione dei calcoli.
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TRATTAMENTO ENDOSCOPICO DELL’URETEROCELE ASSOCIATO A DOPPIO DISTRETTO
RENALE
UTILIZZO DELLA DIMETOSSI - DIIDROSSI - APORFINA COME TERAPIA ESPULSIVA
NELLA CALCOLOSI RENO-URETERALE DOPO TRATTAMENTO DI LITOTRISSIA
EXTRACORPOREA.
A. danti, A. danti, A. elia, L. landi, M. taverna, F. pistolesi (firenze)
Scopo del lavoro
Descrivere la nostra esperienza nel trattamento endoscopico dell’ureterocele associato a doppio distretto
renale.
Materiali e metodi
Un totale di 54 bambini affetti da ureterocele su doppio distretto renale sono stati trattati nel nostro centro
con incisione endoscopica primaria dell’ureterocele in un periodo compreso tra gennaio 2000 e dicembre
2010. la diagnosi è stata effettuata nel periodo prenatale in 48 pazienti. Follow up medio di circa 4.7 anni,
tutti i bambini inclusi sono al momento dello studio continenti. I pazienti sono stati studiati con ecografia ,
SSR, CUM.
Risultati
L’incisione endoscopica dell’ureterocele è stata eseguita nel 95% dei pazienti (51). Tre pazienti hanno
necessitato di ulteriori procedure chirurgiche (anastomosi uretero-ureterale o pielo pielica).
Discussione
L’efficacia di tale procedura endoscopica e la semplicità nella sua esecuzione permette di evitare interventi
chirurgici maggiori a carico della via urinaria.
Conclusioni
L’incisione endoscopia dell’ureterocele , trattamento di scelta del nostro centro , rappresenta una procedura
semplice , non invasiva, con scarsi rischi per il paziente, e definitiva in molti casi.
A. Zordani, M. Sighinolfi, S. Morselli, A. Mofferdin, E. Martorana, M. Rosa, S. Micali, G. Bianchi
(Modena)
Scopo del lavoro
Lo scopo del lavoro è quello di confrontare l’efficacia di Dimettosi-Diidrossi-Aporfina 250 mcg con quella
di Tamsulosina 0.4 mg e con un gruppo di controllo senza terapia medica. L’Aporfina, antagonista diretta
degli adrenorecettori di tipo 1a e 1b, svolge infatti un’azione alfa-litica; recentemente è stata combinata
con l’arbutina ad azione infiammatoria per l’inibizione dell’enzima fosfolipasi A2, l’asparagina ad azione
diuretica e l’herniaria con azione antiadesiva sulle cellule dell’urotelio.
Materiali e metodi
Da Gennaio 2013 a Marzo 2014 abbiamo considerato in maniera prospettica 100 pazienti candidati a
litotrissia extracorporea (ESWL) per urolitiasi a sede pielica ed ureterale. L’ESWL è stata condotta mediante
Dornier Lithotripter S XXP, utilizzando il puntamento sia ecografico che fluoroscopico. Al termine del
trattamento i pazienti sono stati sottoposti a terapia espulsiva mediante aporfina (Renalit Combi Colic®)
per 12 giorni (Gruppo A). Il follow up è stato condotto a circa 30/die dal trattamento ESWL mediante
ecografia renale e radiografia dell’addome. Le variabili considerate sono state: sede e dimensione dei calcoli;
espulsione di frammenti o evidente riduzione di dimensioni del calcolo. I risultati cosi ottenuti sono stati
confrontati con quelli di una serie retrospettiva di 129 pazienti sottoposti ad ESWL, di cui 60 randomizzati
a successiva terapia con tamsulosina 0,4 mg/die per 20/die (Gruppo B) e 69 considerati come gruppo di
controllo senza terapia espulsiva (Gruppo C). La localizzazione dei calcoli era anche a prevalente sede pieloureterale, ed in tutti i casi considerati (A+B+C) era stata evidenziata un’apparente frammentazione in corso
di trattamento.
Risultati
Le dimensioni medie dei calcoli erano pari a 9,3+/-3,5 nel gruppo A, 9,8+/-4,2 nel gruppo con Tamsulosina
e 9,1+/- 2,6 mm nel Gruppo di controllo (p=0,3). L’espulsione di frammenti o comunque un’evidente
riduzione delle dimensioni del calcolo al follow up è avvenuta in 80/100 paz. in terapia con aporfina ed
in 53/60 paz. in terapia con tamsulosina (p=0,17); l’espulsione in entrambi i gruppi sottoposti a terapia
espulsiva (sia A che B) è risultata superiore a quella registrata nel gruppo di controllo (56/69, p=0.0). Non si
sono documentati effetti collaterali (connessi ad ESWL o a terapia medica) in tutti i bracci di trattamento
Discussione
L’utilizzo di Renalit Combi Colic® in questa preliminare esperienza sembra mostrare un’efficacia
sovrapponibile a quella della tradizionale tamsulosina in termini di espulsione dei frammenti e nettamente
superiore al gruppo di controllo. Oltre ad un’analoga efficacia, questa formulazione ha consentito di superare
le difficoltà che si incontrano nella prescrizione di farmaci off label (alfa litico per urolitiasi) in determinate
categorie di pazienti come donne e bambini.
Conclusioni
La nostra esperienza conferma l’efficacia del Renalit Combi Colic come terapia espulsiva nella calcolosi
reno-ureterale, con risultati del tutto analoghi a quelli ottenuti con gli alfa-litici.
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VALUTAZIONE URODINAMICA IN PAZIENTI AFFETTI DA VALVOLE DELL’URETRA
POSTERIORE
CARDIOVASCULAR SAFETY OF DAPOXETINE IN PATIENTS TREATED FOR PREMATURE
EJACULATION: RESULTS FROM A LARGE OBSERVATIONAL POST-MARKETING
EUROPEAN STUDY.
M. Taverna, L. Landi, A. Elia, F. Pistolesi, D. Danti (Firenze)
Scopo del lavoro
Le valvole dell’uretra posteriori neonatali oltre al danno dell’alto apparato urinario e della funzione renale
determinano disfunzioni vescico-uretrali di varia entità. La prevalenza delle disfunzioni è del 75%-80% in
bambini studiati dal punto di vista urodinamico. Scopo di questo lavoro è quello di verificare l’efficacia del
trattamento uro-farmocologico dopo trattamento chirurgico endoscopico precoce.
Materiali e metodi
Sono stati valutati dal punto di vista urodinamico 28 pazienti con diagnosi prenatale dopo folgorazione
endoscopica precoce. La valutazione urodinamica è stata effettuata dopo 6 mesi dal trattamento endoscopico
in tutti i pazienti mediante cistomanometria e successiva uroflussimetria dopo acquisizione del controllo
sfinterico. La valutazione cistomanometrica si è basata sui seguenti parametri: massima capacità vescicale,
compliance vescicale ed attività detrusoriale. La uroflussimetria ha valutato il tipo di flusso e l’eventuale
residuo post-minzionale.
Risultati
L’età media dei pazienti trattati è di 2,5 mesi. Il follow-up medio urodinamico è stato di 5 anni. Alla prima
valutazione urodinamica 20 pazienti presentavano iperattività detrusoriale con contrazioni non inibite, e
7 di questi presentavano elevate pressioni detrusorialia piccolo riempimento; tutti e 20 sono stati trattati
con terapia anticolinergica; 8 pazienti presentavano una buona compliance vescicale senza iperattività
detrusoriale.
Discussione
Al controllo a distanza (5anni) 15 pazienti presentavano buona capacità vescicale e normale compliance
senza iperattività con flusso regolare per morfologia ed indici velocimetrici; 9 pazienti presentavano
un’iperattività detrusoriale con contrazioni non inibite, riduzione della compliance e massima pressione
detrusoriale media di 55+/-15 cm di H2O; di questi 2 presentavano incontinenza; 4 pz, inoltre, presentavano
una vescica ad elevata compliance con ipocontrattilità detrusoriale, flusso intermittente e RPM superiore ad
80 ml alla valutazione Bladder Scanner.
Conclusioni
Il trattamento endoscopico precoce associato allo studio urodinamico e farmacoterapia tendono a ridurre gli
effetti delle dsfunzioni vescicali. Dal nostro studio, inoltre, si evince che, nonostante il trattamento precoce,
la disfunzione vescicale migliora, pur persistendo iperattività detrusoriale, in quanto l’ostruzione, che agisce
già in epoca prenatale, esercita effetti negativi sulla disfunzione vescico-sfinterica.
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P. Verze, R. La Rocca, A. Palmieri, M. Franco, T. Cai, V. Cicalese, D. Arcaniolo, G. La Pera, V. Mirone
(Napoli)
Aim of the study
Dapoxetine hydrochloride is a SSRi and the first drug approved for the on-demand treatment of premature
ejaculation (PE). Its safety was established in a thorough clinical development program. The aim of this
study was to characterize the safety profile of dapoxetine in PE treatment and to report the incidence,
severity, and type of adverse events of special cardiovascular interest.
We conducted a 12-wk, open-label, observational, phase-4 study with a 4-wk, post-observational contact
(PAUSE Study). A total of 6.712 patients were treated with dapoxetine 30-60mg Orthostatic vital signs
(blood pressure and heart rate) were measured during the pre-observational period to assess if any patient
met the criteria for orthostatic hypotension according to the Seventh Report of the Joint National Committee
on Prevention, Evaluation, and Treatment of High Blood Pressure (JNC-7). Baseline information was
described using common statistical descriptors for continuous data, count, and percentages for categorical
data. All reported cardiovascular adverse events with onset during the observational period were included in
the analysis.
Results
The most frequent disorder at baseline was hypertension (511 patients, 8.3%). At total of 99 (1.61%) patients
reported CV TEAEs. Dizziness was the most commonly reported event (53 cases, 6.3%). No event of
syncope was reported in any patient treated with Dapoxetine. Evaluation for orthostatic reaction at baseline
revealed a rate of 1.0% of the patient population. Of these 70 patients, 54 (75.3%) completed the study and
17 (24.7%) were withdrawn from the study. It is worth to note that only 3 out of these 17 patients (4.1%)
dropped out because of adverse events.
Discussion
The data from this large post-marketing observational study demonstrates that Dapoxetine induces a
low prevalence of major neurocardiogenic events (CV TEAEs), especially if a correct assessment for
cardiovascular comorbidities and orthostatic reaction at baseline is provided. Major strength of this study is
the comprehensive collection of data concerning CV TEAEs in a real life setting.
Conclusions
Dapoxetine for the treatment of PE patients shows a good cardiovascular safety profile also when used in
routine clinical practice.
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EFFETTI ANTALGICI DELLA TECAR TERAPIA NEL TRATTAMENTO DELLA PATOLOGIA
DI LA PEYRONIE. STUDIO RANDOMIZZATO A SINGOLO CIECO CON GRUPPO SHAM SU
UN TOTALE DI 96 PAZIENTI.
EIACULAZIONE PRECOCE: TRATTAMENTI A CONFRONTO. TERAPIA MEDICA VS
TERAPIA MEDICA IN ASSOCIAZIONE CON PSICOTERAPIA DI GRUPPO VS PSICOTERAPIA
DI GRUPPO
C. PAVONE, S. romeo, F. d’amato, E. napoli, G. caruana (PALERMO)
M. Vella, D. Abbadessa, S. Gattuso, G. Gambino, C. Pavone (Palermo)
Scopo del lavoro
Abbiamo condotto uno studio randomizzato a singolo cieco con gruppo sham per valutare gli effetti
terapeutici della TECAR terapia su 96 pazienti affetti dalla malattia di La Peyronie (IPP) vista l’efficacia di
questo trattamento sulle patologie fibrose.
Scopo del lavoro
Scopo dello studio è valutare in pz affetti da Eiaculazione Precoce (EP) il trattamento associato
Farmaco+Psicoterapia di gruppo, vs Farmaco, vs Psicoterapia di gruppo in termini di aumento del Tempo di
latenza eiaculatoria intravaginale (IELT) e migliore Qualità di vita (QoL).
Materiali e metodi
Novantasei pazienti affetti da IPP randomizzati con rapporto 2:1 sono stati suddivisi in 2 gruppi: gruppo
trattato e gruppo sham. Abbiamo valutato l’efficacia TECAR sul dolore, sul grado di incurvamento penieno
e sul deficit erettile (DE) al termine del trattamento ed a 1 (FU1) e 3 (FU3) mesi dal termine del trattamento
mediante l’utilizzo della scala VAS per il dolore e di questionari specifici per l’IPP e per il DE (IIEF-5).
Materiali e metodi
Tra gennaio e dicembre 2012 sono stati osservati tra la popolazione maschile afferita all’U.O.C. di Urologia
del Policlinico P. Giaccone di Palermo 540 pz affetti da EP. Da questa popolazione selezionata è stato
arruolato un campione di 270 pz secondo i criteri di inclusione: IELT ≤ a 2 minuti, Premature Ejaculation
Diagnostic Tool (PEDT) ≥ 9, età 18-70 anni. Criteri di esclusione: disturbi psichici, malattie croniche
gravi, uso di sostanze stupefacenti e abuso di alcool. I 270 pz sono stati randomizzati secondo ordine di
arruolamento consecutivo in tre gruppi di 90 pz come segue: Gruppo A-Farmaco, età media 49,8 anni
(range 20-68) Gruppo B-Farmaco+Psicoterapia di Gruppo, età media 49,2 anni (range 20-68) Gruppo
C-Psicoterapia di Gruppo, età media 36,9 anni (range 20-56) Nel Gruppo A e nel Gruppo B è stata impiegata
la Dapoxetina. I pz sono stati seguiti per 20 settimane con 4 visite ambulatoriali. Per il Gruppo B e il Gruppo
C lo strumento psicoterapeutico utilizzato è stato il Gruppo Omogeneo Aperto a cadenza per 20 sedute totali.
Pre e post trattamento è stato somministrato il PEDT, questionario sull’eiaculazione e sulla QoL del pz.
Risultati
Si è registrata una riduzione statisticamente significativa del dolore nel gruppo già al termine del trattamento
in 48 (75%) dei pazienti (p
Discussione
Il nostro è il primo studio randomizzato singolo cieco con gruppo sham che mostra l’efficacia della TECAR
nel ridurre rapidamente il dolore in pazienti con IPP.
Conclusioni
La semplicità di esecuzione e l’elevata tollerabilità del trattamento da parte del paziente rendono tale
metodica una valida ed innovativa opzione terapeutica per i pazienti affetti da IPP
Risultati
Centoventi (44,4%) dei 270 pz arruolati non sono stati complianti alla terapia e non vi sono dati al riguardo.
GRUPPO A Sessanta dei 90 pz arruolati hanno terminato il protocollo, IELT medio pre-trattamento di 79,75
sec (range 15 sec–120 sec) e punteggio medio al PEDT 15,95 (EP grave). Nel post trattamento lo IELT
medio è stato di 203 sec e punteggio medio al PEDT è 8,26 (moderata EP).In 13 (21,6%) pz si è evidenziato
un miglioramento del quadro clinico con punteggi medi PEDT a termine di terapia ≤ 8, e IELT riferito
≥ 2 . GRUPPO B Sessanta dei 90 pz arruolati hanno concluso il protocollo, IELT medio pre-trattamento
di 74,25 sec (range 15 sec–120 sec) e punteggio medio PEDT di 16 (EP grave). Nel post trattamento lo
IELT medio è stato di 200 sec e punteggio medio al PEDT di 3,3 (assenza/basso livello di EP). In tutti i
pazienti del Gruppo (100%) si è riscontrato miglioramento dell’EP GRUPPO C Trenta dei 90 pz arruolati
hanno concluso il protocollo, IELT medio pre-trattamento di 75 sec (range 15 sec–120 sec) e punteggio
medio PEDT di 15,7. Nel post trattamento lo IELT medio è stato di 186 sec e punteggio medio al PEDT di
4,03(assenza/basso livello di EP).Quindici pz (50%) hanno riportato miglioramento della EP.
Discussione
Il Gruppo A ha riportato miglioramenti nello IELT e nel PEDT nel 21,6% dei casi; il Gruppo B in tutti i pz
(100%), mentre il Gruppo C nel 50% dei casi.
Conclusioni
La terapia associata si è dimostrata efficace nel trattamento dell’EP con aumento significativo dello IELT e
punteggi al PEDT rientranti nel range di “normalità” al post trattamento.
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HEALTHCARE PROVIDERS ADHERENCE TO THE RISK MINIMIZATION MEASURES
FOR PRESCRIBING DAPOXETINE SIGNIFICANTLY REDUCES THE TEAES INCIDENCE:
RESULTS FROM A LARGE EUROPEAN OBSEREVATIONAL STUDY
MINIMAL CLINICALL IMPORTANT DIFFERENCES (MCIDS) IMPROVEMENT OF THE IIEFERECTILE FUNCTION DOMAIN IS A PROXY OF PATIENT WEANING FROM TADALAFIL
OAD IN MEN WITH PSYCHOGENIC ERECTILE DYSFUNCTION – REALISTIC PICTURE
FROM THE EVERYDAY CLINICAL PRACTICE
M. Franco, P. Verze, R. La Rocca, A. Palmieri, T. Cai, V. Cicalese, D. Arcaniolo, G. La Pera, V. Mirone
(Napoli)
Scopo del lavoro
Dapoxetine hydrochloride is a selective serotonin reuptake inhibitor and the first drug approved for the
on-demand treatment of premature ejaculation (PE). Its safety was established in a thorough clinical
development program.This study characterize the safety profile of Dapoxetine in PE treatment and
investigate the role of Healthcare providers’ (HCP) adherence to the risk minimization measures for
prescribing dapoxetine in order to reduce the TEAEs incidence.
Materiali e metodi
We conducted a 12-week, open-label, observational study with a 4-week post-observational contact. A total
of 10,028 patients were enrolled, with 6,712 patients (67.6%) treated with Dapoxetine (Group A) 30-60 mg
and 3,316 (32.4%) treated with alternative-care/non Dapoxetine (Group B). Healthcare providers were asked
to follow scheduled posology and method of administration recommendations.
Risultati
Orthostatic reaction testing was conducted for the large majority of group A patients (97.8%). Most of
the group A patients were 99.9%, respectively). The frequency of alcohol use was similar between groups
A and B. The overall prevalence of psychiatric disorder diagnoses at baseline was 6.9% in group A and
11.0% in group B. A total of 58 patients (0.9%) treated with Dapoxetine were prescribed a contraindicated
concomitant therapy during the course of the study. Antidepressants were the most frequently used class of
drugs. A total of 540 patients (8.8%) treated with Dapoxetine used a concomitant medication with special
warnings and precautions for use: phosphodiesterase type 5 inhibitors (PDE5-Is) (5.5%) and α-blockers
(3.3%). 93.0% of group A patients were initially prescribed Dapoxetine 30 mg.
Discussione
results of the present study suggest the high adherence of HCP to the contraindications, special warnings,
and precautions for the use of Dapoxetine. These include a medical history with the presence of orthostatic
reaction and/or the use of concomitant therapies that are contraindicated (antidepressants, potent CYP3A4
inhibitor, triptans) or have precautions and warnings when used with dapoxetine (α-blockers, moderate
CYP3A4 inhibitor, nitrates, PDE5 inhibitors, potent CYP2D6 inhibitor). This was confirmed by the adequate
identification of patients at risk for orthostatic reaction due to medical history evaluation and orthostatic
testing, the prescription of a 30-mg starting dose in >90% of PE patients, and the concomitant use of drugs
with special warnings and vasodilatory properties in
P. Capogrosso, M. Colicchia, L. Boeri, A. Serino, E. Ventimiglia, A. Pecoraro, A. Russo, G. Castagna, F.
Castiglione, G. La Croce, A. Briganti, F. Cantiello, R. Damiano, F. Montorsi, A. Salonia (Milan)
Aim of the study
Assess efficacy, treatment satisfaction and erectile function (EF) confidence in a cohort of patients with pure
psychogenic erectile dysfunction (ED) treated with tadalafil 5mg once daily (OaD).
Data from 100 consecutive patients seeking first medical help for pure psychogenic ED throughout the last
24 months were analysed. Health-significant comorbidities were scored with the Charlson Comorbidity
Index (CCI). Tadalafil 5mg OaD was prescribed to all patients for not less than 6 months. Patients
completed a baseline IIEF before therapy and at survey. Patients were requested to complete a non-validated
questionnaire assessing compliance to and subjective satisfaction over the prescribed therapy. Descriptive
statistics and logistic regression models tested patients compliance to and efficacy of long-term treatment
with tadalafil OaD [also considering MCIDs criteria].
Results
Patients mean (SD) age was 45.3 (11.9) yrs (range: 21-54). Of all, 30 (30%) patients refused to answer at
the survey. Of the remaining 70 patients, 57 (57%) did use the treatment as prescribed, while 13 (13%)
patients did not even start the therapy. Thirty (52.6%) of the total amount of patients taking tadalafil OaD
discontinued the therapy at the end of the first 6 months course; conversely, 27 (47.4%) kept taking the drug
over the prescribed course. Mean IIEF-EF significantly improved for both groups at FU evaluation (p
Discussion
Several studies showed high drop-out rates from PDE5is therapy ranging between 45% and 78% after 6–24
months. The only positive reason for discontinuing PDE5is is considered EF recovery. In this context our
findings showed that tadalafil OaD significantly improved EF of patients with psychogenic ED. Of all, 63%
of patients were confident of having full erections after drug discontinuation. Conversely, almost half of
them did not discontinue the therapy after the first prescription of 6 months. MCID improvements of EF
domain was the only independent factor associated with patient’s confidence in discontinuing therapy.
Conclusions
MCIDs improvement of IIEF-EF was a proxy of patient weaning from tadalafil OaD continuous treatment.
Conclusioni
The high adherence of HCP to the contraindications, special warnings, and precautions for the use of
Dapoxetine minimizes the risk for its use.
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P 48
P 49
PELVIC FLOOR MUSCLE REHABILITATION FOR PATIENTS WITH LIFELONG
PREMATURE EJACULATION: A NOVEL THERAPEUTIC APPROACH
PREDICTORS OF TEAES CAUSED BY DAPOXETINE IN PATIENTS TREATED FOR PE:
RESULTS FROM A LARGE EUROPEAN OBSERVATIONAL STUDY
A. Pastore, G. Palleschi, D. Autieri , L. Silvestri, A. Leto, A. Ripoli, Y. Al Salhi, C. Maggioni, A. Fuschi, A.
Carbone (Latina)
M. Franco, P. Verze, R. La Rocca, A. Palmieri, T. Cai, V. Cicalese, D. Arcaniolo, G. La Pera, V. Mirone
(Napoli)
Scopo del lavoro
Premature ejaculation(PE)is the most common male sexual disorder.Intravaginal ejaculatory latency
time(IELT)is defined as the time from vaginal intromission to intravaginal ejaculation.In the present
study,men with lifelong PE underwent pelvic floor muscle(PFM) rehabilitation by using modifications of the
techniques used in the treatment of urinary incontinence,including physiokinesitherapy, electro-stimulation
and biofeedback. The primary objective of our study was to evaluate the effectiveness of PFM rehabilitation
by measuring changes in IELT after 12 weeks of therapy.
Aim of the study
on-demand treatment of premature ejaculation (PE). Its safety was established in a thorough clinical
development program. Aim of the study is to determine independent predictors of any grade TEAE in PE
patients treated with Dapoxetine.
Materiali e metodi
Between July 2010 and August 2012,40 male patients with lifelong PE and a baseline IELT≤60
seconds(mean: 31.7 s, range: 16.6–57.4 s).The patients were all treated with PFM rehabilitation.To evaluate
the effectiveness of PFM rehabilitation,we compared the mean IELT values of the patients after 12 weeks of
treatment.The rehabilitation treatment group comprised 40 patients aged 19–46 years (mean age: 30 years)
with a mean baseline IELT of 31.7 ± 14.8 s(range: 16.6–57.4 s).The PFM rehabilitation protocol consisted
of (1) physiokinesitherapy;(2)electro-stimulation; and(3) biofeedback. The patients had three 60-min therapy
sessions each week, during which the 3 techniques were applied for 20 min each. The results were measured
after the first 20 sessions (6 weeks) and then again at the end of therapy (12 weeks).
Risultati
At the end of 12 weeks,33 (82.5%)of the 40 patients gained control of their ejaculation reflex.Five patients
were non-responsive to the treatment,whereas 2 improved their ejaculation after the first 20 sessions and
opted to drop out of the study. None of the patients reported adverse effects .At the first evaluation after
6 weeks of rehabilitation,the patients achieved a mean IELT of 124.6 ± 18.4 sec(range: 122.7–143.1 sec).
At the end of week 12 of the PFM rehabilitation, the mean IELT was 146.2 ± 38.3 sec(range: 129.6–184.5
sec).13/33(39%)patients reached 6 months follow-up and the mean reported IELT was 112.6 ± 16.4
seconds(range:108.7–121.1 sec),which resulted significant when compared to their initial IELT(mean 39.8
sec;range: 24-6 – 56.3 sec).
Discussione
In the present study, the pelvic floor exercises led to an improvement in body and, especially, pelvic floor
awareness in all of the enrolled subjects, which helped them improve their self-confidence and sense of
control of their ejaculatory reflex.In addition, we demonstrated that active perineal muscle control inhibits
the ejaculation reflex through intentional relaxation of the bulbo and ischio-cavernous muscles, which are
active during arousal and should be intentionally relaxed during this phase of sexual intercourse.
Conclusioni
Results obtained in our patients with lifelong PE suggest that PFM rehabilitation may be considered as a
therapeutic option for patients with PE.The results of the subgroup,which reached the 6 months evaluation
after the end of PFM rehabilitation, confirm the good efficacy of this treatment even at a longer follow-up.
48
and 3,316 (32.4%) treated with alternative-care/non Dapoxetine (Group B). Treatment-emergent adverse
events (TEAEs) and concomitant therapy use during the 12-week observational and the post-observational
period were reported. We performed a multivariate logistic regression analysis for predicting the outcome of
dichotomous dependent variables for group A patients, with a statistically significant p value set at <0.05.
Results
The mean age for all patients was 40.5 years. 93.0% of the patients in Group A were initially prescribed
dapoxetine 30 mg. Treatment options for Group B patients included clomipramine, paroxetine, fluoxetine,
sertraline, topical drugs, condoms and behavioral counseling. Both treatment regimens were well-tolerated.
TEAEs were reported by 12.0% and 8.9% of group A and B respectively, with the highest incidence
observed in patients aged > 65 years for group A (21.4%) and 30-39 years (9.8%) for group B. Independent
predictor of any grade TEAEs were identified: presence of cardiovascular disorders at baseline (OR = 0.619,
p
Discussion
The data from this post-marketing observational study demonstrates that Dapoxetine for treatment of PE has
a good safety profile, with low prevalence of TEAE also in routine clinical practice. Multivariate logistic
regression analysis assessed the variables predicting incidence of any grade TEAEs. It is interesting to note
that among predictors, cardiovascular disorders (the absence of CV disorders at baseline decreased TEAE
hazard by 38%), metabolic disorders (the absence of metabolic disorders at baseline decreased TEAE
hazard by 29%), alcohol assumption (more than 15 drinks/week increased TEAE hazard 1.5 times), PE
diagnosis (lifelong diagnosis increased TEAE hazard by 32% related to acquired diagnosis) were found to be
statistically significant.
Conclusions
the results of this post-marketing observational study demonstrates that Dapoxetine for treatment of PE has
a good safety profile, with low prevalence of TEAE, and the identification of independent predictors of any
grade TEAEs can support the management of PE patients treated with dapoxetine.
49
P 50
P 51
RESULTS FROM A PROSPECTIVE OBSERVATIONAL STUDY OF MEN WITH PREMATURE
EJACULATION TREATED WITH DAPOXETINE OR ALTERNATIVE CARE: THE PAUSE
STUDY
RIABILITAZIONE ANDROLOGICA POST-PROSTATECTOMIA RADICALE CON TECNICA
NERVE-SPARING: MODELLO TOSCANO
R. La Rocca, P. Verze, A. Palmieri, M. Franco, T. Cai, V. Cicalese, D. Arcaniolo, G. La Pera, V. Mirone
(Napoli)
Scopo del lavoro
on-demand treatment of premature ejaculation (PE). This study aims to characterize the safety profile of
Dapoxetine in PE treatment and to report the incidence, severity and type of adverse events.
Materiali e metodi
and 3,316 (32.4%) treated with alternative-care/non Dapoxetine (Group B). Treatment-emergent adverse
events (TEAEs) and concomitant therapy use during the 12-week observational and the post-observational
period were reported.
Risultati
The mean age for all patients was 40.5 years. 93.0% of the patients in Group A were initially prescribed
dapoxetine 30 mg. Treatment options for Group B patients included clomipramine, paroxetine, fluoxetine,
sertraline, topical drugs, condoms and behavioral counseling. Both treatment regimens were well-tolerated.
TEAEs were reported by 12.0% and 8.9% of group A and B respectively, with the highest incidence
observed in patients aged > 65 years for group A (21.4%) and 30-39 years (9.8%) for group B.
Discussione
Most adverse events were mild to moderate and related to the gastrointestinal or nervous system. The most
commonly reported TEAEs were nausea, headache, and vertigo with a higher incidence in group A (3.1%,
2.6%, and 1.0%, respectively) than in group B (oral drugs 2.3%, 1.3%, and 0.9%, respectively). There were
no cases of syncope in Group A and one single case in Group B. The high adherence of health care providers
to the contraindications, special warnings, and precautions for Dapoxetine minimizes the risk for its use in
routine clinical practice.
Conclusioni
The results of this post-marketing observational study demonstrates that Dapoxetine for treatment of PE has
a good safety profile, with low prevalence of TEAE.
A. Tuccio, G. Siena, A. Minervini, A. Sebastianelli, M. Salvi, A. Chindemi, C. Giannessi, J. Frizzi, O. Saleh,
N. Mondaini, D. Villari, A. Canale, R. Bartoletti, S. Serni, G. Nicita, M. Carini (Firenze)
Scopo del lavoro
Valutare se la somministrazione gratuita degli inibitori delle fosfodiesterasi (PDE5I)aumenti il tasso di
adesione al trattamento e incida sul recupero della potenza sessuale nei pazienti sottoposti a prostatectomia
radicale nerve-sparing (RPNS)
Materiali e metodi
Da Dicembre/2006 la Regione Toscana ha autorizzato la fornitura gratuita di PDE5I a pazienti sottoposti
a RPNS con residenza in Toscana.Abbiamo condotto un’analisi multicentrica,in una coorte di pazienti
con residenza in Toscana e quindi con acccesso gratuito al farmaco(FREE-P)versus una coorte di
pazienti con residenza extra-regione con il farmaco a proprie spese(PAY-P). Sono stati registrati i
seguenti dati preoperatori:residenza,età,BMI,familiarità per tumore di prostata,abuso di alcolici o
sostanze stupefacenti,fumo di sigaretta, scolarità,stato civile,numero di rapporti a settimana prima
dell’intervento,Charlson Comorbidity Index(CCI),comorbidità,pregressi interventi chirurgici,International
Index of Erectile Function(IIEF-5)Questionnaire preoperatorio,PSA e stadio clinico.Sono stati registrati
inoltre:il tipo di procedura chirurgica,stadio patologico,score di Gleason,recidiva biochimica,trattamenti
adiuvanti,re-interventi nei 24 mesi successivi all’intervento di prostatectomia radicale. I criteri di inclusione
sono stati:pazienti sottoposti a RPNS, 22,non in terapia adiunvante,privi di rischi cardiovascolari, con CCI
< 1.Alla visita di controllo sono stati somministrati i questionari EDITS(Erectile Dysfunction Inventory of
Treatment Satisfaction)per la valutazione della soddisfazione con il trattamento per la disfunzione erettile
ed UCLA-PCI-funzione sessuale(University of California,Los Angeles-Prostate Cancer Index)per valutare
lo score di funzionalità erettile postoperatorio.Le differenze statisticamente significative sono state valutate
mediante l’analisi multivariata di regressione logistica.
Risultati
Da gennaio 2008 a Dicembre 2012, 2168 pazienti sono stati sottoposti a RP in 4 centri Toscani.826 pazienti
sono stati inclusi nell’analisi finale,648 di questi con residenza in Toscana(FREE-P group) e 182 con
residenza extra-regione(PAY-P group). All’analisi multivariata la residenza in Toscana è risultata essere un
fattore predittivo indipendente di uno score UCLA-PCI-funzione sessuale>500(RR 3.18;CI95%; p=0.02).
Non è stata registrata nessuna differenza statisticamente significativa tra i gruppi FREE-P vs PAY-P per
quanto riguarda lo score al questionario EDITS.
Discussione
L’inizio precoce della riabilitazione, la maggiore adesione al protocollo terapeutico e il minor dropout farmacologico possono essere fattori determinanti nella ripresa della funzionalità erettile postprostatectomia.
Conclusioni
In una coorte di pazienti sottoposti a RPNS, 22 e con minime comorbidità,la somministrazione gratuita di
farmaci PDE5I ha prodotto uno score di funzionalità erettile 3 volte superiore rispetto ad uno stesso gruppo
di pazienti con il farmaco a suo carico.
50
51
P 52
P 53
SEVERE OBSTRUCTIVE SLEEP APNEA SYNDROME AND ERECTILE DYSFUNCTION:
A PROSPECTIVE RANDOMISED STUDY TO COMPARE SILDENAFIL VERSUS NASAL
CONTINUOUS POSITIVE AIRWAY PRESSURE
TADALAFIL OAD IMPROVES SYMPTOMS ASSOCIATED WITH PEYRONIE’S DISEASE
THROUGHOUT THE ACUTE INFLAMMATORY PHASE - RESULTS OF A PROOF OF
CONCEPT PSYCHOMETRIC STUDY
A. Pastore, G. Palleschi, L. Silvestri, A. Ripoli, Y. Al Salhi, D. Autieri, A. Leto, A. Fuschi, C. Maggioni, A.
Carbone (Latina)
L. Boeri, L. Rocchini, P. Capogrosso, M. Colicchia, A. Serino, E. Ventimiglia, G. Castagna, C. Regina, F.
Castiglione, A. Pecoraro, A. Russo, A. Briganti, R. Damiano, F. Montorsi, A. Salonia (Milan)
Aim of the study
A high incidence of erectile dysfunction (ED) among patients with obstructive sleep apnea syndrome
(OSAS) has been reported, with a strong correlation between obstructive sleep apnea, ED, and quality
of life (QOL), and it has been estimated that 10–60% of patients with OSAS suffer from ED. In this
prospective randomised controlled trial, we investigated 82 men with ED consecutively who were referred
to the outpatient clinic for sleep disorders and had severe OSAS (AHI>30 events/h) without any other
comorbidities as a possible cause of ED. The aim of this study was to evaluate and compare the efficacy of
sildenafil versus continuous positive airway pressure (CPAP) in men with ED and severe OSAS.
Aim of the study
Assess the efficacy of tadalafil OaD in relieving symptoms associated with acute inflammatory phase of
Peyronie’s Disease (PD).
Eighty-two patients were randomised to 2 main treatment groups: group 1 patients (n=41) were treated with
100-mg sildenafil 1 h before sexual intercourse without CPAP, and group 2 patients (n=41 men) were treated
with only nasal CPAP during night time sleep. Both groups were evaluated with the same questionnaires
(International Index of Erectile Function-EF domain; Sex Encounter Profile; Erectile Dysfunction Inventory
Treatment Satisfaction) 12 weeks after treatment.
Results
In patients receiving sildenafil treatment, 58.2% of those who attempted sexual intercourses were successful
compared to 30.4% in the CPAP group. The mean number of successful attempts per week was significantly
higher in the sildenafil group compared to the CPAP group (2.9 vs 1.7, respectively; p
Discussion
Our study is, to date, the only trial that has investigated PDE5i in patients with severe OSAS.We reported
a high overall response rate to 100-mg sildenafil treatment compared with those reported in the previous
studies in the literature. The encouraging results obtained in our study are correlated to the selection of
enrolled patients, which provided strict exclusion criteria. The high response rate to sildenafil may be due
to the exclusion of major diseases responsible for ED, such as hypertension, diabetes, prostate cancer,
current alcohol or drug abuse, and medications, which could affect erectile function. The direct smooth
muscle relaxation in the penile arteries and corpora cavernosa achieved by sildenafil may explain the higher
effectiveness of this treatment compared to CPAP, and this efficacy may therefore explain the greater
number of intercourse attempts, reflecting the patients strengthened self- confidence.
Conclusions
In the present study sildenafil was more effective than CPAP in treating ED associated with OSAS, as
indicated by a significantly higher rate of successful attempts at intercourse and higher IIEF-EF domain
scores. Our study is, to date, is the only trial that has investigated sildenafil in patients with severe OSAS.
52
Sociodemographic and clinical data from 91 consecutive patients presenting with acute inflammatory phase
PD and treated with tadalafil OaD for not less than 6 consecutive months were analyzed. Health-significant
comorbidities were scored with the Charlson Comorbidity Index (CCI) (0 vs 1 vs ≥2). All patients completed
the IIEF-erectile function (IIEF-EF) domain at baseline and at survey. Moreover, all patients completed a
remembered Peyronie’s Disease Questionnaire (PDQ) (http://www.auxilium.com/PDQ), which targeted
the impact and severity of PD symptoms in 3 domains, including 1) psychological and physical symptoms
(=PDQ1), 2) penile pain (=PDQ2), and 3) symptom bother (=PDQ3) regarding a period preceding the
treatment with tadalafil OaD, and a real-time PDQ, targeting the 4 weeks prior to the survey. Descriptive
statistics and logistic regression models tested the association between tadalafil OaD treatment and potential
predictors of PDQ improvements.
Results
Descriptive statistics: mean (SD) age: 54.4 (11.8) yrs; BMI: 26.4 (3.8) kg/m2; CCI: 0.4 (0.7). After a mean
period of treatment of 8.9 (1.2) mos, tadalafil OaD significantly improved all PDQ domains (pre vs post
PDQ1: 3.3 (4.5) vs 2.3 (3.5); PDQ2: 2.3 (3.3) vs 0.9 (1.9); and, PDQ3: 2.4 (2.8) vs 1.5 (2.1), respectively
(all p≤0.01). Likewise, IIEF-EF was significantly improved (p
Discussion
The lack of a ‘gold standard’ treatment for PD makes difficult to provide recommendations in everyday
practice. The role of PDE5Is as conservative treatment for PD is controversial. This study includes patients
with acute inflammatory phase PD, in which the anti-inflammatory and anti-fibrotic effects of PDE5Is can
be more effective. Physicians are used to undervalue the psychological impact of PD on their patients. We
performed the first real life, observational, cross-sectional study evaluating the role of tadalafil OaD on
patients’s physical and psychological symptoms using a new validated questionnaire.
Conclusions
The results of this proof of concept psychometric study showed that tadalafil OaD, taken for not less than 6
consecutive mos, significantly improved all psychometric domains of PDQ in patients presenting for acute
inflammatory phase PD.
53
P 54
P 55
TADALAFIL ONCE DAILY AND INTRALESIONAL VERAPAMIL INJECTION: A NEW
THERAPEUTIC DIRECTION IN PEYRONIE’S DISEASE.
TERAPIA FARMACO-RIABILITATIVA DINAMICA E COMPORTAMENTALE
DELL’EIACULAZIONE PRECOCE : RISULTATI DI UNO STUDIO PROSPETTICO
RANDOMIZZATO
L. DELL’ATTI, G. Ughi, C. Ippolito, G. Capparelli, S. Papa, L. Fornasari, G. Daniele, G. Russo (Cona)
Scopo del lavoro
The aim of this study was to evaluate the combination of intralesional Verapamil injection (IVI) therapy with
and Tadalafil in men affected by Peyronie’s disease (PD).
Materiali e metodi
In this prospective, randomized study between April 2010 and May 2013, 59 consecutive patients diagnosed
with PD, were divided: Group A (GA) 23 patients (pt) treated with IVI 10mg, one injection per week for
12 weeks; Group B (GB) 19 pt with Tadalafil 5mg once daily for 3 months; Group C (GC) 17 pt with
both therapeutic agents for 3 months. The inclusion criteria of the pt were: disease not > 12 months, a
single penile plaque demonstrated by dynamic sonography, plaque’s maximum size of 3,75cm2 and penis
recurvatum < 0,05 was considered to indicate statistical significance.
Risultati
Three months after the therapy in GA pain resolved completely or partially in 57% (13/23) of the pt, while
in 61%(11/18) and in 76%(13/17) cases of GB and GC respectively. GA pt had a reduction from a mean
of 21.4 degrees at baseline to a mean of 19.8 degrees after the 12 week protocol (P=0.284). Pt in GB had
a reduction from a mean of 22.03 degrees at baseline to a mean of 20.05 degrees after treatment (P=0.34),
while in GC a mean of 21.80 degrees vs 19.6 degrees after treatment respectively (P=0.87). Mean plaque
size remained stable in GA: 1.57 vs 1.59 at baseline (P=0.364) and GB: 1.51 vs 1.52 at baseline (P=0,265),
while a further decrease was evident in GC: 1.46 vs 1.58 at baseline (P= 0.03).(Figure1) Mean IIEF-5 score
further improved significantly in the group treated with IVI plus Tadalafil: 23.1 vs 14.4 of GA and 18.2 of
GB (P=
Discussione
In our study curvature degree decreased in all groups without statistically differences from baseline values,
while a further decrease of plaque size was evident in the group treated with the association of the two
therapeutic agents (P=0.03). This lower rate of deterioration in penile curvature could be explained by the
short-term follow-up. Certainly the limit of our study, in addition to a non-high number of patients treated
in draw each group, was to have had a short period of follow-up. This prevents information on the natural
course of the plaque or the possible long-term efficacy of Tadalafil.
Conclusioni
This study demonstrates an interesting therapeutic signal in which Tadalafil used daily has a role on
antifibrotic activity in PD and in its treatment. This action is valid when combined strategically to the
synergistic action of IVI directly into the plaque.
F. Mantovani, E. Patelli, C. Antolini (Milano)
Scopo del lavoro
L’eiaculazione precoce (EP) è un disturbo della sessualità caratterizzato da eccessiva rapidità orgasmica.
In media, da casistiche internazionali, la prevalenza coinvolge il 25% della popolazione maschile fra i 25 e
55 anni. Si distingue in primaria (60%) ovvero presente sin dall’esordio dell’attività sessuale, e secondaria
(40%) manifesta successivamente. In comune hanno una ridotta latenza eiaculatoria, una mancanza di
controllo e/o di percezione soggettiva del tempo all’eiaculazione. Dapoxetina rappresenta, oggi,l’unico
preparato approvato per la terapia on demand dell’EP. La terapia riabilitativo-comportamentale dinamica
può rappresentare una valida opportunità terapeutica d’affiancare a quella farmacologica purchè sia
ottimale il coinvolgimento partecipativo del singolo e della coppia con spiegazioni, esemplificazioni ed
addestramento semplici, precisi e controllati.
Materiali e metodi
Sono stati arruolati 18 pazienti d’età compresa fra 25 e 55 anni, tutti con EP primaria, esenti da
comorbidità e coinvolgendo la partner. A 6 pazienti è stata prescritta dapoxetina 30 mg. due ore prima
dei rapporti per 3 mesi. N. 6 pazienti sono stati introdotti al trattamento riabilitativo dinamico consistente
nella tonificazione del pubo-coccigeo, muscolo perineale fondamentale nel controllo dell’eiaculazione,
mediante Fisiokinesiterapia (FKT) giornaliera domiciliare previa dimostrazione ambulatoriale ed 1
applicazione settimanale per 3 mesi d’innervazione magnetica extracorporea (ExMI-Neocontrol) seguita da
elettrostimolazione funzionale (ESF) e da biofeedback (BFB) con sonda rettale (MyoPlus 40Hz) in assetto
dinamico mediante erezione indotta e mantenuta con vacuum (Rapport-Medis) tutto in sede ambulatoriale.
Nei 3 mesi la coppia veniva inoltre addestrata alla terapia comportamentale domiciliare ( Sensate - Squeeze
- Stop and Start ). Ad altre 6 coppie infine veniva assegnato il trattamento integrale farmaco-riabilitativo
dinamico e comportamentale associando i due precedenti approcci sempre per mesi 3.
Risultati
Sono stati acquisiti mediante colloquio di coppia e ricompilazione del questionario PEDT al termine
dei 3 mesi di trattamento e dopo altrettanti mesi di stopterapia con fortunata assenza di dropout o
defezioni al followup. Terapia farmacologica = 75% ok a 3 mesi / 25% a 6 mesi.Terpia riabilitativa
dinamica e comportamenale = 25% ok a 3 mesi / 25% a 6 mesi.Terapia farmaco-riabilitativa dinamica e
comportamentale = 75% ok a 3 mesi / 50% a 6 mesi. Nell’ambito dei risultati positivi il punteggio PEDT si
riduceva da una media di 12 ad una di 6.
Discussione
L’integrazione della terapia farmacologica con la riabilitazione dinamica e comportamentale ha il preciso
intento d’ottimizzare i risultati.
Conclusioni
Salvo evidenza di comorbidità da risolversi in primis, la somministrazione di dapoxetina per l’immediato
ci trova favorevoli. L’associazione con la riabilitazione dinamica e comportamentale sembra offrire più
apprezzabile stabilità di risutati.
54
55
P 56
P 57
UROTENSIN-II RECEPTOR HIGH AFFINITY AGONIST LIGANDS: A NEW THERAPEUTIC
APPROACH TO ERECTILE DYSFUNCTION
A MORE EXTENSIVE PELVIC LYMPH NODE DISSECTION IS ASSOCIATED WITH
IMPROVED SURVIVAL OF PATIENTS WITH NODE POSITIVE PROSTATE CANCER.
M. Capece, M. Franco, R. La Rocca, M. Acquaviva, R. D’Emmanuele di VIlla Bianca, F. Fusco, G. Cirino,
R. Sorrentino, V. Mirone (Napoli)
M. Bianchi, V. Cucchiara, E. Zaffuto, V. Scattoni, A. Mistretta, A. Nini, E. Di Trapani, F. Abollah, N. Suardi,
V. Mirone, A. Salonia, F. Montorsi, A. Briganti (Milano)
Aim of the study
Urotensin II (U-II) is a cyclic peptide that acts through a G protein-coupled receptor (UTR) mainly involved
in cardiovascular function in humans. The urotensinergic system is also implicated in the urogenital tract.
Indeed, U-II relaxes human corpus cavernosum strips and causes an increase in intracavernous pressure
(ICP) in rats. In light of this, the U-II/UTR pathway can be considered a new target for the treatment of
erectile dysfunction. On this hypothesis, herein we tested new UTR high affinity-agonists, P5U (H-Aspc[Pen-Phe-Trp-Lys-Tyr-Cys]-Val-OH) and UPG84(H-Asp-c[Pen-Phe-DTrp-Orn-(pNH2)Phe-Cys]-Val-OH).
Aim of the study
The association between the extent of pelvic lymph node dissection (PLND) and patient survival is currently
a controversial topic in prostate cancer. Only a few retrospective reports found an association between
the extent of PLND and patient outcome. However, these studies are limited by the lack of standardized
anatomical template of nodal dissection. We therefore tested the association between the extent of nodal
dissection and patient survival in a large, single center cohort of node positive patients treated with extensive
nodal dissection.
The effects of P5U and UPG84 were each compared with U-II by monitoring the ICP in anesthetized rats.
Intracavernous injection of U-II (0.03-1 nmoles), P5U (0.03-1 nmoles) or UPG84 (0.03-1 nmoles) was made
and ICP was measured. ICP caused by P5U and UPG84 was then noted and compared each other.
The study included 540 consecutive node-positive patients treated with radical prostatectomy (RP) and
anatomically defined extended pelvic lymph node dissection (ePLND) at a single European tertiary referral
centre between January 1992 and June 2010. ePLND consisted of removal of obturator, external iliac,
hypogastric +/- pre-sacral and common iliac lymph nodes. Kaplan-Meier curves assessed time to cancer
specific and overall survival. Moreover, univariable and multivariable Cox regression analyses were
performed to address predictors of cancer specific and overall mortality. Covariates consisted of patient age
and PSA at surgery, pathological Gleason sum, pathological stage, number of positive lymph nodes, number
of lymph nodes removed and adjuvant radiation and hormonal therapy.
Results
Intracavernous injection of U-II (0.03-1 nmoles), P5U (0.03-1 nmoles) or UPG84 (0.03-1 nmoles) caused an
increase in ICP. P5U, in particular, elicited a significant increase in ICP as compared to U-II. The observed
effect by using P5U at a dose of 0.1 nmol/rat was comparable to the effect elicited by U-II at a dose of 0.3
nmoles. Moreover, UPG84 at the lowest dose (0.03 nmoles) showed an effect similar to the highest dose of
U-II (1nmoles).
Discussion
UPG84 was found to be more effective than P5U. Indeed, while the lowest dose of P5U (0.03 nmoles) did
not affect the ICP UPG84, at the same dose, induced a prominent penile erection in rat. These compounds
did not modify the blood pressure which indicates a good safety profile.
Conclusions
In conclusion, in this era of PDE5i therapy, the development of UTR ligands may represent a new
therapeutical approach for the management of erectile dysfunction and requires further investigation in this
direction.
Results
Mean follow-up was 65 months (median: 63). Mean age at surgery was 65.5 yrs (median 66). Mean and
median PSA at surgery was 26.6 and 11.5 ng/ml, respectively. Pathological stage was pT2, pT3a, pT3b and
pT4 in 9.1%, 20%, 64.3% and 6.5% respectively. Pathological Gleason score 8-10 was present in 50.7%
of patients. Mean and median number of lymph nodes removed were 21 and 19, respectively. Mean and
median number of positive lymph nodes were 3.7 and 2, respectively. Adjuvant radiotherapy and hormonal
therapy were given to 39.8 and 84.4%, respectively. The 8 and 10-year cancer specific and overall survival
rates were 85 and 80%, and 73.4% and 70% . At multivariable analyses, after adjusting for all confounders,
the number of lymph nodes removed was significantly inversely associated with both cancer specific and
overall mortality (p= 0.02; HR: 0.92 and p=0.01; 0.93, respectively). The number of positive lymph nodes,
pathological Gleason score 8-10 and adjuvant RT were also significantly associated with patient survival (all
p≤0.02)
Discussion
In node positive patients more extensive PLND is significantly associated with improved cancer specific and
overall survival rates.
Conclusions
In conclusion, a meticulous PLND is advocated in these patients.
56
57
P 58
P 59
ASSESSING THE OPTIMAL EXTENT OF SALVAGE LYMPH NODE DISSECTION IN
PATIENTS WITH SINGLE PELVIC NODAL UPTAKE AT [11C]-CHOLINE PET/CT SCAN FROM
RECURRING PROSTATE CANCER
ASSESSING THE OPTIMAL POST-OPERATIVE MANAGEMENT OF NODE POSITIVE
PROSTATE CANCER PATIENTS: RESULTS FROM A LARGE, MULTI-INSTITUTIONAL
SERIES.
F. Castiglione, V. Cucchiara, G. Gandaglia, N. Di Muzio, F. Cantiello, A. Nini, A. Larcher, M. Moschini, N.
Passoni, R. Damiano, A. Gallina, F. Montorsi, A. Briganti (Milano)
A. Briganti, K. Toujer, J. Karnes, P. Scardino, J. Eastham, N. Fossati, N. Passoni, F. Montorsi (Milano)
Aim of the study
Salvage lymph node dissection (sLND) may represent a possible therapeutic approach for patients with
limited nodal recurrence and absence of distant metastases. However, there is no consensus about the
optimal anatomical extent of sLND. This is mainly based on the heterogenous pathway of nodal metastatic
spread and on the low sensitivity of PET/CT for micrometastatic nodal recurrence. The aim of our study was
to assess the anatomical extent of sLND in men with single nodal pelvic [11C]-choline uptake in order to
correctly plan sLND.
We retrospectively reviewed data from 70 patients who underwent sLND after a positive PET/CT
examination reporting a single nodal uptake suggestive of nodal recurrence after radical prostatectomy (RP).
Seventeen patients who underwent only retroperitoneal sLND were excluded from analysis. In the remaining
population of men who received both pelvic and retroperitoneal sLND, we excluded 22 patients who had
tracer uptake in the retroperitoneum, leaving 31 men with tracer uptake only in a single spot in the pelvis
eligible for analysis. Frequencies were used as descriptive statistics. Chi-square and independent t test were
used for comparisons.
Results
Median Time from RP to sLND was 49.7 months (IQR: 31.5- 75.9 months). Overall, the median number of
removed LNs at sLND was 26 (IQR 17-37) and the median number of positive LNs was 2 (IQR 1-9). Out
of 31 men, 27 had positive LNs (87%). Of these, 14 (45%) had nodal disease only in the pelvis, 1 (3%) only
in the retroperitoneum, and 12 (39%) in both locations. Among the 13 men with histologically confirmed
retroperitoneal LN metastases, 3 (23%) had uptake in the common iliac nodes, 9 (69%) in the external iliac
stations and 1 (8%) had uptake in the external iliac, internal iliac and obturator stations. Men with positive
retroperitoneal LNs at sLND had significantly higher rates of positive LNs at radical prostatectomy (50% vs
17%, p=0.01). There were no other significant differences in clinical and pathological features between the
two groups of patients (all p>0.06).
Discussion
Retroperitoneal LN involvement among patients with [11C]-choline uptake in the pelvis is seen in a
common finding, seen in 40% of the patients. Extending the dissection up to the retroperitoneum despite
the presence of single positive spot in the pelvis at imaging may have rationale in men with positive pelvic
lymph nodes at previous radical prostatectomy.
Aim of the study
Controversy exists about the optimal post-operative management of lymph node (LN) positive prostate
cancer patients. The only level 1 evidence data support the role of adjuvant hormonal therapy for all men
with positive LNs. However, controversy exists regarding the validity of these findings in contemporary
patients with micrometastatic LN disease. The aim of our study was to assess the optimal post-operative
management of LN positive prostate cancer patients recruited from a large, multi-institutional series.
We retrospectively reviewed 1,338 LN positive patients treated with patients RP and extended pelvic lymph
node dissection from 3 tertiary referral centers between 1988 and 2010. Patients were divided into three
groups according to post-operative treatment status, namely observation (n=387; 27.9%), adjuvant androgen
deprivation therapy (ADT) (n=676;48.7%) or a combination of adjuvant radiation therapy (aRT) and
ADT (n=325;23.4%). Multivariable Cox competing risk models assessing the impact of different adjuvant
therapies on both cancer-specific mortality (CSM) and other-cause mortality (OCM) were fitted adjusting for
age at surgery, pathological Gleason score and stage, number of positive LNs and surgical margin status.
Results
Median follow-up time was 72 months (IQR 49-128 months). Median number of removed LNs was 14 (IQR
10-20), while the median number of positive LNs was 1 (IQR 1-2). Patients managed with observation were
younger (median age 62.1 vs 66 vs 64.5), had lower PSA at surgery (8.5 vs 14.1 vs 14.8 ng/mL), had higher
rates of pT2/pT3a disease (56% vs 37% vs 22%) and lower rates of positive surgical margins (33% vs 55%
vs 72%), compared to men treated with ADT or RT-ADT combination, respectively (all p<0.0001).
Discussion
Multimodal treatment seems to confer the best cancer control with the least impact on OCM in patients with
positive LNs after RP and ePLND. However, whether this is true for all men with node positive disease still
needs to be demonstrated.
Conclusions
Further prospective studies are needed for risk-stratification and to corroborate these findings.
Conclusions
In these patients nodal tumor load may be significantly higher than what detected at [11C]-choline PET/CT
scan.
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59
P 60
P 61
CLINICAL RECURRENCE OF SURGICALLY TREATED PATIENTS WITH NODE POSITIVE
PROSTATE IS NOT INVARIABLY SYSTEMIC: IMPORTANCE OF OPTIMAL PELVIC DISEASE
CONTROL
EXTENSION AND RATE OF LYMPH NODE INVASION OF PELVIC LYMPH NODE
DISSECTION DURING ROBOT-ASSISTED RADICAL PROSTATECTOMY ACCORDING TO
D’AMICO CLASSIFICATION. AN ANALYSIS OF A SINGLE-CENTER EXPERIENCE.
M. Bianchi, F. Abdollah, N. Suardi, M. Freschi, R. Lucianò, A. Nini, F. Castiglione, N. Fossati, P.
Dell’Oglio, A. Abrate, E. Zaffuto, F. Montorsi, A. Briganti (Milano)
E. DE LORENZIS, B. ROCCO, G. ALBO, D. BUNIATO, M. SPINELLI, P. DELL’ORTO, F. GADDA, P.
ACQUATI, M. ROSSO, F. ROCCO (MILANO)
Aim of the study
Node positive prostate cancer (PCa) is not invariably a systemic disease. Certain sub-groups of this patient
category may benefit from maximal local disease control. We assessed the sites of clinical recurrence (CR)
in surgically treated node positive patients.
Aim of the study
Pelvic lymph node dissection (PLND) is the most accurate staging procedure for patients diagnosed with
organ-confined prostate cancer who undergo radical prostatectomy. Several studies showed that an extended
PLND is feasible during robotic assisted radical prostatectomy (RARP). To evaluate extension of PLND
and lymph nodes metastasis rates, according to D’Amico’s classification, in patient underwent to RARP and
PLND in our Institution.
We evaluated data from 540 patients with lymph node positive PCa treated with radical prostatectomy and
extended pelvic lymph node dissection (ePLND) between 1990 and 2008 at a single tertiary referral center.
Of these, 92 (17%) developed CR. Patients were stratified into two groups, based on their CR status: local
vs. distant. Local CR was defined as recurrence in the prostate bed and/or pelvic lymph nodes (LN) up to the
common iliac lymph nodes. Distant CR was defined as any LN recurrence beyond the common iliac nodes,
in the bone, and/or in other solid organs. Tumor characteristics were compared between the two groups
using T student and chi-square test. Moreover, Kaplan-Meier analysis was used to estimate cancer-specific
survival rates according to site of clinical recurrence. This association was also tested using Cox regression
models predicting cancer specific mortality (CSM) after adjusting for confounders.
Results
Mean numbers of nodes removed at ePLND was 22.5 (median: 20), and mean number of positive nodes was
4.9 (median: 2.0). Most patients had a pathological Gleason score 8-10 (54.3%), and a pathological stage
of pT3b/pT4 (83.7%). Surgical margins were positive in 68.5% of patients. Clinical relapse was local in
48.9% and distant in 51.1% of patients respectively. Patients with distant CR had a non-statistically higher
mean PSA value (31.7 vs. 27.8 ng/mL, p=0.6), higher mean number of nodes removed (23.2 vs. 21.8 nodes,
p=0.6), and higher number of positive nodes (6.1 vs. 3.7 nodes, p=0.1) as compared to patients with local
CR. Likewise, patients with distant CR had significantly higher rates of poorly differentiated tumor (Gleason
score 8-10: 78.6% vs. 45.9%, p=0.005), as compared to patients with local CR. Mean time from surgery to
CR was 31.2 and 25.7 months in patients with local and systemic CR, respectively (p=0.4). Mean time from
CR to CSM was 30 months, being 38.4 and 22.5 months in patients with local and systemic CR, respectively
(p=0.04). Overall, cancer specific survival (CSS) 5 years after CR was 63.5%, being 71.7% in patients with
local CR vs. 51.8% in patients with distant CR (p=0.6). At multivariable analysis, independent predictors of
CSM consisted of total number of nodes removed (hazard ratio [HR]: 0.93, p=0.03), and number of positive
nodes (HR: 1.2, p=0.002), while CR site was not associated with CSM ( HR: 0.64; p=0.4).
Discussion
In patients with node positive PCa, CR was not invariably systemic. Roughly 50% of patients had indeed
pelvic, rather than systemic recurrence.
Conclusions
These data support the importance of improving local and pelvic control in node positive patients who are
not invariably affected by systemic progression of the disease.
60
Between January 2011 to March 2013, 286 patients underwent RARP in our Institution. Of these, 173 were
evaluable for the analysis. We retrospectively reviewed our prospectively collected database and stratified
patients into 3 groups according to D’Amico classification. Then we performed a comparison between
standard (sPLND) versus extended PLND (ePLND).
Results
The preoperative characteristics of the patients are shown in table 1. According to d’Amico classification,
45 patients (26%) were classified as high risk, 60 patients (35%) as intermediate risk while the remaining 68
patients (39%) were low risk. Overall, PLND was performed in 72 patients (41.6%). Of these, 37 were high
risk (51.4%), 34 intermediate risk (47.2%) and one patient was low risk (1.4%). In the high risk group, 37/45
patients (82.2%) underwent PLND, 34/60 (56.7%) in the intermediate group and 1/68 (1.5%) in the low risk
group. The mean number of nodes removed was overall 17.25+/-11.1; 17.05+/- 7.7 in the high risk group,
17.27+/-14.1 in the intermediate risk group and 24 in the low risk group. Among patients who performed
PLND, lymph node invasion (LNI) was found in 15 patients (20.8%). LNI was found in zero, 5 (14.5%),
and 10 (27%) of the low, intermediate, and high risk patients who underwent PLND, respectively ( table 2)
ePLND was performed in 22/72 patients (30.5%). The mean number of nodes removed was 14.06 +/-7.3 for
the sPLND and 24.36 +/-14.6 for the ePLND. LNI was observed in the 16.3% of sPLND and in the 27.3%
of ePLND. The lymph nodes density was 2.3% for sPLND and 2.0% for ePLND.
Discussion
In our cohort we observed a higher rate of LNI to those reported in literature, especially in high risk patients.
As expected, ePLND is associated with high number of lymph nodes removed. The strengths of this
study are the stratification into risk groups and the comparison between standard and extended PLND; all
specimens were analysed by expert pathologists. Limitations of this study are its retrospective design and the
limited number of patients included.
Conclusions
In our experience, the lymph node yeld in the robotic setting is satisfactory. The extended template of PLND
improves staging and increases detection rate of LNI. D’Amico risk classification can be considered a good
predictor of LNI in patients undergoing PLND during RARP.
61
P 62
P 63
Robotic-Assisted Extended Pelvic Lymph-Adenectomy for high-risk
prostate cancer: technical feasibility and results after 153 cases.
HYPOGONADISM IS AN INDEPENDENT PREDICTOR OF NODAL METASTASES IN
PROSTATE CANCER PATIENTS UNDERGOING EXTENDED PELVIC LYMPH NODE
DISSECTION
Porpiglia F., De Luca S., Morra I., Bertolo R. Grande S., Mele F., Amparore D., Cattaneo G., Garrou D.,
Scarpa R.M.,Bollito E., Fiori C.
Department of Urology; Department of Pathology - University of Turin, San Luigi Hospital, Orbassano
(Turin)
Introduction and objectives
The aim of the study was to describe the technical feasibility of robotic-assisted extended pelvic lymphadenectomy (RAEPLA) in patients with high-risk PCa.
From April 2010 to September 2013, we performed RAEPLA in 153 patients prior to robotic-assisted
radical prostatectomy. Demographic data of the patients are shown in Table 1. Indication for RAEPLA was
defined according to Briganti nomogram (based on pre-treatment prostate-specific antigen (PSA), clinical
stage, primary and secondary biopsy Gleason score, and percentage of positive cores). The transperitoneal
approach was used in all cases by placing six ports. The lymphatics covering the distal tract of the common
iliac artery, the medial portion of the external iliac artery, the external iliac vein and the internal iliac vessels,
the obturator and the presacral lymphatic packets were removed on both sides. The total lymph node yield,
the frequency of lymph node metastases, and the complication rate were evaluated retrospectively.
Results
The median number of lymph nodes removed was 25 for each patient (IQR: 19.25-30). On the left side the
mean number of lymph nodes removed was 11 (IQR: 8-15), while to the right side was 13 (IQR: 11-16). In
19 patients (12:41%) were detected lymph node metastases, with mean PSA of 8.2 (IQR 5.5-16.5) ng / ml.
The mean number of positive nodes was 1 for each patient (IQR: 1-4.6). The location and the number of
metastases for each anatomical region are shown in Table 2. The mean hospital stay was 5 days (IQR 4-7).
In 11 patients complications were recorded (7.3%): one case of neurapraxia (sciatic nerve and obturator) and
postoperative lymphocele in 10 cases (6.6%), all managed conservatively.
Discussion
RAEPLA is a feasible procedure,the lymph node yield is comparable to open series, and the procedurerelated morbidity seems to be acceptable.
E. Ventimiglia, P. Capogrosso, M. Colicchia, L. Boeri, A. Serino, G. Castagna, F. Castiglione, G. La Croce,
A. Gallina, N. Suardi, A. Briganti, R. Damiano, F. Montorsi, A. Salonia (Milano)
Aim of the study
To assess the association between preoperative hypogonadism (defined as total testosterone (tT)
Preoperative serum tT was measured in a cohort of 1009 consecutive Caucasian-European patients (mean
age 64.8 years, range 41-84) submitted to RP with ePLND. None of the patients had taken any hormonal
neoadjuvant treatment or other hormonal preparations during the previous 12 mo. Serum tT was measured
the day before surgery (8–10 AM) in all cases. Logistic regression models tested the associations among
predictors (eg, prostate specific antigen [PSA], clinical stage, biopsy Gleason score, and tT) and LNI.
Results
Median tT was 4.5 ng/ml [mean: 4.5; range: 0.02–13.6]. Hypogonadism was observed in 208 (20.6%)
patients. LNI was found in 113 (11.2%) patients, with a mean number of lymph nodes removed of 19.2.
Mean serum tT level did not vary in patients with LNI as compared with those without LNI; conversely,
hypogonadism was found in a significantly greater rate in pN+ patients (Chi2: 6.98; 30.1% vs 19.4%,
p=0.008). At UVA hypogonadism was a LNI predictor (OR 1.79, p 0.009). At multivariable logistic
regression analysis hypogonadism emerged as an independent predictor of LNI (OR 1.81; p=0.03), after
accounting for clinical stage, biopsy Gleason score and PSA levels.
Discussion
Sex hormones have been implicated in prostate carcinogenesis, through their several roles in modulating cell
proliferation, cell differentiation, cell growth. In our study we show how hypogonadic patients might have a
higher rate of LNI; beside this, hypogonadism emerges as independent predictor of LNI.
Conclusions
The results of this study provide evidence that hypogonadism might serve as an independent predictor of
LNI in patients with PCa undergoing ePLND.
Conclusions
The robotic-assisted approach doesn’t seem to limit surgeon’s ability to perform a complete EPLA.
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63
P 64
P 65
INDIVIDUAL SURGEON COMMITMENT TO PELVIC LYMPH NODE DISSECTION RATHER
THAN SURGICAL VOLUME IS A MAJOR DETERMINANT OF THE EXTENT OF NODAL
DISSECTION DURING ROBOT-ASSISTED RADICAL PROSTATECTOMY
LONG TERM OUTCOMES OF SALVAGE LYMPH NODE DISSECTION FOR CLINICALLY
RECURRENT PROSTATE CANCER: RESULTS OF A SINGLE INSTITUTION SERIES WITH A
MINIMUM FOLLOW-UP OF 5 YEARS.
E. Zaffuto, G. Gandaglia, N. Fossati, D. Vizziello, M. Bianchi, A. Gallina, R. Damiano, F. Cantiello, R.
Colombo, V. Mirone, G. Guazzoni, F. Montorsi, A. Briganti (Milano)
E. Di Trapani, N. Suardi, M. Tutolo, D. Di Trapani, M. Freschi, R. Luciano’, C. Cozzarini, N. Di Muzio, R.
Damiano, F. Cantiello, A. Salonia, F. Montorsi, A. Briganti (Milano)
Aim of the study
Previous studies showed substantial variability in the number of lymph nodes removed during pelvic
lymph node dissection (PLND) in patients treated with robot-assisted radical prostatectomy (RARP) for
prostate cancer (PCa). The aim of our investigation was to evaluate the impact of the surgeon experience
and individual surgeon commitment on the number of nodes removed during PLND in patients treated with
RARP.
Aim of the study
The management of patients with clinical recurrence of prostate cancer after radical prostatectomy (RP)
remains challenging. Despite the absence of prospective, randomized studies, salvage lymph node dissection
(sLND) for patients with lymph node recurrent disease is gaining attention. However, data on long term
outcomes of this surgical approach are still lacking. We tested the outcome of sLND in a single institution
series of patients with a minimum follow-up of 5 years.
Overall, 1,173 patients with PCa treated with RARP between February 2006 and August 2013 by four
experienced surgeons at a single center were identified. Surgical volume was coded as the number of robotic
cases done by the surgeon before the index patient’s operation. The surgeon ID was numerically classified
as follows: surgeon 1, 2, 3, and 4. The Kruskal-Wallis test was used to compare median number of nodes
removed stratified according to the surgeon ID. Multivariate linear regression analyses were fitted to identify
the predictors of the extent of PLND (namely, the number of lymph nodes removed). Covariates consisted
of clinical stage, biopsy Gleason score, preoperative PSA, surgeon ID, and surgical volume. We repeated our
analyses after stratifying patients according to NCCN risk group (lowvs. intermediate/high-risk).
The study focused on 59 patients affected by BCR after RP associated with a nodal pathologic [11C] choline
PET/CT scan. Patients underwent imaging guided salvage lymph node dissection (LND) between 2002 and
2008 at a single tertiary referral center. Biochemical response (BR) to treatment was defined as prostatespecific antigen (PSA)
Results
Mean patient age was 62.5 years (median: 63). Mean surgical volume was 194 (median: 190; interquartile
range [IQR]: 86-298). Overall, 825 patients (70.3%) received PLND. The median number of lymph node
removed was 8 (mean: 10). The median number of nodes removed significantly varied according to the
surgeon performing the operation (from 6 to 12 for surgeon 1 and surgeon 4, respectively; p
Results
Mean PSA at sLND was 3.95 ng/ml (median 2 ng/ml; IQR: 0.81-5.35). Mean age at sLND was 66.6 years
(median 66.4 years). [11C] choline PET/CT scan showed nodal uptake in the pelvis only in 36 patients
(61%), in the retroperitoneum only in 10 patients (16.9%) and in both in 13 patients (22%). Overall, 59.3%
of patients achieved BR. Median follow-up after LND were 75.9 (IQR: 61.6-98.3). The 8-yr BCR-free
survival rate in patients with complete BR to surgery was 23%. Overall, 8-yr CR-free and cancer-specific
survival were 28% and 81%, respectively. At UVA, PSA at sLND (HR:1.12, p
Discussion
We found that surgical experience is not a significant predictor of the number of nodes removed.
Discussion
Salvage LND may represent a therapeutic option for patients with BCR after RP and nodal pathologic
uptake at [11C]choline PET/CT scan. Biochemical response after surgery can be achieved in a consistent
proportion of patients.
Conclusions
In patients treated with RARP undergoing PLND, individual surgeon commitment rather then the surgical
experience has a major impact on extent of nodal dissection.
Conclusions
Although most patients invariably progressed to BCR after surgery at longer follow-up, one third of patients
showed the absence of CR 8 yr after surgery.
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65
P 66
NODAL OCCULT METASTASES IN INTERMEDIATE AND HIGH RISK PROSTATE CANCER
PATIENTS DETECTED BY SERIAL SECTION, IMMUNOHISTOCHEMISTRY AND REAL-TIME
REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION: PERSPECTIVE EVALUATION
WITH MATCHED PAIR ANALYSIS.
Cristian Vincenzo Pultrone, Elisa Capizzi*, Marco Borghesi, Valerio Vagnoni, Daniele Romagnoli, Giorgio
Gentile, Lorenzo Bianchi, Hussam Dababneh, Francesca Giunchi*, Antonietta D’Errico*, Michelangelo
Conclusion. The current pathological techniques are inaccurate. SS, IHC and RT-PCR can detect a not
negligible percentage of OCM missed at RPE. RT-PCR contributes the most. Cost-effective analysis and
follow-up studies are needed.
Table 1: Results of SPE, SS, IHC and real time RT-PCR assay in the 108 patients of the matched-pair
population and of the 54 patients of the study population (patient analysis).
Fiorentino*, Simona Rizzi, Eugenio Brunocilla, Giuseppe Martorana, Riccardo Schiavina.
Introduction. Lymph node metastases (LNM) are the strongest predictor of a poor prognosis in patients with
Serial section
Matched-pair
Study population
population
Patients
Patients
(overall: 108)
(overall: 54)
18 (16.6%)
11 (20.3%)
14 (25.9%)
prostate cancer (PCa) after radical prostatectomy (RP). Preoperative nomograms that consider established
Immunohystochemistry
-
15 (27.7%)
4 (7.4%)
RT-PCR
-
17 (31.4%)
6 (11.1%)
SS + IHC + RT-PCR
-
18 (33.3%)
7 (13.%)
Clinica Urologica, Alma Mater Studiorum Università di Bologna, Bologna, Italia.
* UO Anatomia Patologica, Policlinico S. Orsola-Malpighi, Alma Mater Studiorum Università di Bologna,
Bologna, Italia.
Histological technique
Standard pathological examination
markers such as prostate-specific antigen (PSA), stage, number of positive cores and Gleason score (Gs) can
provide an estimate of the risk of LNM, but are still imperfect in individual patients. Standard pathological
evaluation (SPE) is usually limited to few cross-sections per LN, and therefore might not identify LNM with
a small diameter, thus understaging a substantial number of patients. To overcome these limitations, several
methods have been utilized over time, such as serial sections (SS), immunohistochemistry (IHC), and realtime PCR (RT-PCR). Aim of our study was to prospectively evaluate the incidence of nodal occult metastases
(OCM) assessed separately by SS, IHC and RT-PCR in PCa patients compared to the SPE.
Material and Methods. Fifty-four consecutive patients at intermediate or high-risk prostate cancer treated
with radical prostatectomy and extended pelvic lymph-node dissection (PLND) composed the study population
(StP). The central sections with the largest diameter of each LN of the StP and a matched-pair population
(MpP) with identical characteristics as StP were used to assess the improved detection rate of OCM.
Results. 1064 LNs were processed in the 54 patients of the StP, with 11 (20.4%) patients with evident metastases
at SPE and 7 with OCM (13.0% additional patients); RT-PCR detected 6/7 patients. When considering the 108
patients of the MpP, the percentage of positive patients improved from 16.6% (18/108) of the MpP to 33.3%
(18/54) of the StP (16% additional patients). On a LN based analysis, 28/1064 (2.6%) LNs were metastatic
at SPE in the StP, with 44 (4.1%) additional LNs affected by OCM. RT-PCR detected 38/44 (86.3%) of
these additional LNs. The mean diameter of the 10 additional LNs with OCM found at SS only and of the 6
additional LNs found at IHC only was significantly lower than the mean diameter of the 28 metastases fond
at RPE (P<0.0001).
66
67
reference
3 (5.5%)
P 67
P 68
MORE EXTENSIVE PELVIC LYMPH NODE DISSECTIONS DURING ROBOTIC ASSISTED
RADICAL PROSTATECTOMY ARE ASSOCIATED WITH HIGHER RATES OF PERIOPERATIVE COMPLICATIONS. RESULTS OF A SINGLE INSTITUTION SERIES.
PELVIC LYMPH NODE DISSECTION CAN BE SAFELY OMITTED IN MEN WITH A RISK OF
NODAL METASTASES ≤5% BASED ON THE BRIGANTI NOMOGRAM: VALIDATION OF THE
EAU GUIDELINS RECCOMENDATIONS FOR NODAL DISSECTION BASED ON PATIENT
OUTCOME.
D. Vizziello, M. Moschini, N. Buffi, M. Tutolo, M. Bianchi, F. Abdollah, A. Gallina, F. Cantiello, R.
Damiano, R. Colombo, G. Guazzoni, F. Montorsi, A. Briganti (Milan)
Aim of the study
Extended pelvic lymph node dissection (ePLND) represents the most accurate method to assess the presence
of lymph node metastases in prostate cancer (PCa). However, previous studies have reported higher rates of
complication associated with ePLND in men treated with open retropubic radical prostatectomy. Only few
data are available on ePLND related complications during robotic assisted radical prostatectomy (RARP).
We therefore tested the associations between ePLND and complications in a large series of patients treated
with RARP at a single center.
The study included 1,466 patients with complete clinical and pathological data treated with RARP at a
single institution between 2006 and 2013. Patients were divided according to the rate and extent of PLND
performed during RARP into three groups: no PLND (n= 454;31%; Group 1), PLND with
Results
Mean and median age was 62.7 and 63 years, respectively. Overall, a Grade I or more complication occurred
in 201 patients (13.7%). Of these, 61 (30.3%), 83 (41.3%), 53 (26.4%), 4 (2%) and 0 had a Grade I, II,
III, IV and V complication, respectively. The most common complication was anaemia requiring blood
transfusion in 90 patients (6.1%) followed by lymphorrea/lymphocele in 32 (2.2%), pelvic hematoma in 19
(1.3%) of which 9 required surgical intervention) and urine leak in 14 (1%). Patients with >10 lymph nodes
removed had significantly higher rates of overall complication (17.8%) as compared to patients with 10
lymph nodes removed had a 1.7 higher risk of peri-operative complications as compared to patients with no
or limited PLND, after adjusting for confounders (p=0.03). However, such increased complication rate did
not translate into longer hospital stay or increased blood loss (all p>0.1)
Discussion
Only more extensive PLNDs during RARP are associated with higher rates of intra- and peri-operative
complications. In patients treated with PLND, the number of lymph nodes removed represents indeed an
independent predictor of Grade I or more complications.
Conclusions
These results should be taken into account in the risk-benefit assessment of ePLND during RARP.
N. Suardi, F. Abdollah, A. Gallina, U. Capitanio, M. Bianchi, E. Di Trapani, P. Dell’Oglio, A. Nini, A.
Abrate, N. Buffi, F. Montorsi, A. Briganti (Milano)
Aim of the study
The updated EAU guidelines recommendations on the need for pelvic lymph node dissection (PLND) in
prostate cancer indicate to omit PLND in all men with a risk of lymph node invasion (LNI) ≤5% based on
the updated Briganti nomogram. Such recommendations have been given based on previous staging studies.
However, whether PLND and its extent have no impact on cancer control in these patients with limited LNI
risk has not been proven yet.
This study included 1406 patients treated with radical prostatectomy with or without anatomically extended
pelvic lymph node dissection (PLND), between 1999 and 2012. All patients had a lymph node invasion
(LNI) predicted probability ≤5% according to the Briganti nomogram. All had complete clinical and followup data. Kaplan-Meier curves assessed the time to BCR, defined as two subsequent prostate-specific antigen
values of 0.2 ng/ml or higher. Cox regression tested the relationship between PLND status and biochemical
recurrence (BCR) in the overall population. Likewise, Cox regression tested the relationship between the
number of removed nodes and BCR in patients treated with PLND. Multivariable analyses were adjusted for
all confounders, such as PSA, clinical stage, biopsy Gleason sum and percentage of positive cores.
Results
Mean patients age was 65.1 years (median: 66.0, range: 44.0-80.0). Mean and median follow-up times were
46.6 and 39.0 months, respectively. Most patients (87.7%) received PLND. Among these, the mean number
of removed nodes was 15.1 (median: 14.0, range: 8-52). Overall, the 5- and 7-years BCR rates were 93.2%
and 87.1%, respectively. These rates were respectively 90.6% and 90.6% in patients treated without PLND
vs. 93.3% and 86.9% in patients treated with PLND (p=0.9). At multivariable analysis, PLND status was
not a significant predictor of BCR risk (hazard ratio [HR]: 0.69, p=0.4). In patients treated with PLND, the
number of removed nodes was not an independent predictor of BCR risk at univariable (HR: 1.00, p=0.9)
and multivariable analyses (HR: 1.00, p=0.7).
Discussion
We report the first validation of the EAU guidelines recommendation on the need for PLND in prostate
cancer based on post-operative patient outcome. Neither PLND nor its extent was significantly associated
with improved cancer control in men with a LNI risk ≤5% according to the Briganti nomogram. Therefore, a
PLND can be safely omitted in these patients.
Conclusions
Pelvic lymph node dissection can be safely omitted in patients with a risk of lymph node metastases lower
than 5% according to the Briganti nomogram.
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69
P 69
SENTINEL LYMPH NODE SURGERY IN PROSTATE CANCER: RESULTS AFTER 10 YEARS
FOLLOW UP
Giansilvio Marchioro, Paolo Mondino, Alessandro Volpe, Matteo Vidali, Roberto Tarabuzzi, Stefano
Zaramella, Gianmarco Bondonno, Marco Rudoni, Paolo Gontero, Bruno Frea, Carlo Terrone
Aims:
Rationale for performing sentinel lymph node surgery in prostate cancer is to restrict the extension of pelvic
lymphadenectomy in order to reduce morbidity. A few studies have reported this technique, supporting high
sensitivity but no long term follow-up data are currently available. To evaluate the detection rate and outcomes
of patients undergoing sentinel lymph node surgery (SLNs) with 10 years follow up.
Material and Methods:
From February 2000 to October 2005, one hundred and twenty three patients with histological proven PC
underwent SLNs at the time of a radical retropubic prostatectomy (RRP). 99mTc- nanocolloid was injected
under trans rectal ultrasound guidance in each lobe 24 hours before surgery and scintigrafic images were
taken. Surgery was usually performed after 22-24 hours from the injection of the radiotracer. Intraoperatively,
a hand-held gamma probe (ScintiProbe MR100 – Pol hi tech) was used to scan the lymphatic areas previously
identified by scintigraphy as SLN for selective surgical excision. Hot spots detected in possible sites of pelvic
LN out of those revealed by scintigraphy were also dissected. A bilateral PLND was then performed.
Patients with LNS and found negative (LNS-pN +) Were compared with with patients with LNS and found
positive (LNS + pN +) and with patients with LNS not found (LNS-). Kaplan-Meier curves and Cox regression
analysis were used to assess cancer specific survival (CSS), overall survival (OS) and biochemical recurrence
free survival (BCR) rates.
Table 1
N.
Age (median,
IQR)
PSA (median,
IQR)
pT3 – pT4
pT3
pT4
OS (10 aa)
CCS (10 aa)
BCR (10 aa)
All
LNS+pN+
LNS+pN0
LNS-
p
123
69 (64-71)
13
69 (60-70)
87
68 (65-71)
23
69 (64-74)
p=0,2
9,8 (6
9-16,4)
48 (39%)
41
(85,4%)
7 (14,6%)
14,2 (8,427,5)
11 (84,6%)
7 (63,6%)
9,8 (6,414,9)
28 (32,2%)
26 (92,6%)
9,2 (7,0p=0,2
14,3)
9 (39,1%) p=0,001
8 (89,9%)
75%
96%
83%
4 (36,4%)
29%
68%
0%
Results:
In up to 20% of cases no SLN could be detected. The scanning in vivo ScintiProbe showed the presence of 173
LNS. In 62% of cases the LNS was outside the obturator fossa. In 13 patients it was found 1 metastatic LN
and these have had a biochemical recurrence. No additional pathological disease (pN+) was detected through
PLND in all patients found to have a negative SLN. Patients with LNS-and LN + pN- demonstrated a BCR
survival rate greater than 80% at 10 years. Table 1 compares the results and survival in the three groups with
a mean follow-up of 115 months (median 120, IQR 102-142, min-max 12-162).
Conclusions:
This study shows highly sensitive in detecting nodal disease extension in PC patients for SLNs and confirms
high variability of lymphatic drainage prostate. With a median follow-up of 10 years, our data demonstrate
that absence of LNS or negative LNS can be considered indicators of low-risk lymph node metastatic disease
and good prognosis.
70
71
2 (7,4%)
83%
100%
95%
1 (1,1%)
71%
95%
82%
p=0,001
p<0,001
p<0,001
P 70
P 71
ANALISI DELLA CURVA DI APPRENDIMENTO DOPO 300 PROSTATECTOMIE ROBOTICHE
F. Gallo, M. Schenone, P. Cortese, G. Ninotta, G. Vigliercio, C. Giberti (Savona)
ANASTOMOSI VESCICO-URETRALE CON IMPIEGO DEL DISPOSITIVO FILBLOC® IN
CORSO DI PROSTATECTOMIA RADICALE LAPAROSCOPICA: RISULTATI DI UNO STUDIO
RETROSPETTIVO DI CONFRONTO CON ANASTOMOSI MEDIANTE TECNICA VAN
VELTHOVEN E SUTURA VYCRIL®.
Scopo del lavoro
L’obiettivo di questo lavoro è confrontare cronologicamente i dati relativi alle prime 300 prostatectomie
robotiche eseguite da un’equipe chirurgica senza alcun precedente training laparoscopico tradizionale.
V. Imperatore, S. Di Meo, R. Buonopane, M. Creta (Naples)
Materiali e metodi
Nel periodo compreso tra marzo 2005 e marzo 2013, 324 pazienti sono stati pazienti a prostatectomia
robotica (RALP). Tali pazienti sono stati divisi in 3 gruppi cronologicamente consecutivi da 108 pazienti
ciascuno. Le caratteristiche preoperatorie (età, valori di PSA, stadiazione oncologica), perioperatorie (tempi
operativi, giorni di degenza, giorno di rimozione del catetere, tasso di trasfusioni, complicanze, margini
chirurgici positivi) e postoperatorie (risultati oncologici e funzionali) sono state analizzate nei tre gruppi.
Risultati
Per quanto concerne i dati operatori, i tempi chirurgici sono risultati significativamente ridotti tra il primo
(4.0 ore) e il secondo gruppo (2.49 ore) di pazienti (2.34 ore nel terzo gruppo). La degenza media si è
significativamente ridotta tra il primo (7 giorni) e il terzo gruppo (5 giorni) di pazienti. Il tasso di trasfusioni
è risultato significativamente ridotto tra il primo (16.7%), il secondo (9.3%) e il terzo gruppo (0%). Il
tasso di complicanze si è significativamente ridotto tra il secondo (32.4%) e il terzo (14%) gruppo. Non si
è osservata alcuna riduzione significativa nel tasso di margini positivi nei tre gruppi di pazienti. Riguardo
ai dati postoperatori, un lieve ma non significativo miglioramento della sopravvivenza libera da recidiva
biochimica si è osservata nei tre gruppi con una percentuale pari a 97.2% nel terzo gruppo di pazienti in
cui, tuttavia, il minor follow-up tende ad influenzare negativamente l’analisi statistica. Nessuna differenza
significativa è stata riscontrata nei tre gruppi in termini di percentuale di conservazione della continenza (>
85% in tutti e tre i gruppi) e della potenza sessuale (> 71.5% nel secondo e terzo gruppo).
Discussione
Pur ammettendo la mancanza di una precedente esperienza laparoscopica tradizionale, i nostri dati
parrebbero confermare come la curva di apprendimento in chirurgia robotica sia effettivamente più lunga di
quanto comunemente si creda.
Conclusioni
In base alla nostra esperienza, circa 200 RALP sono risultate sufficienti per constatare un significativo
miglioramento dei parametri chirurgici (tempi operativi, degenza, tasso di trasfusioni e complicanze).
Per quel che riguarda i dati oncologici (percentuali di margini positivi, sopravvivenza libera da malattia
biochimica) e funzionali (ripresa della continenza e della potenza), pur registrando risultati molto
confortanti, circa 300 RALP non sono risultate sufficienti per constatare un significativo miglioramento di
questi parametri.
Scopo del lavoro
Lo scopo del presente studio è confrontare i risultati intra-operatori e post-operatori relativi all’impiego della
sutura Filbloc ® per il confezionamento dell’ anastomosi uretro-vescicale (AUV) in corso di prostatectomia
radicale laparoscopica (LRP) con quelli ottenuti mediante impiego di sutura tradizionale.
Materiali e metodi
Da Gennaio 2012 a Marzo 2014 sono stati eseguiti 40 interventi di LRP con confezionamento di AUV
mediante impiego della sutura Filbloc®. La tecnica ha previsto l’impiego di una singola sutura Filbloc®
(2-0, 5/8). Il primo passaggio auto ancorante viene effettuato ad ore 4, si procede quindi al confezionamento
del piatto posteriore, al posizionamento del catetere vescicale 20 Ch e successivamente al completamento
del piatto anteriore. Le seguenti variabili intra-operatorie e post-operatorie sono state valutate: durata
dell’intervento, durata del confezionamento dell’AUV, complicanze intra-operatorie, risultati della
cistografia post-operatoria eseguita in settima giornata post-operatoria, durata della cateterizzazione,
complicanze post-operatorie, continenza urinaria. Tali variabili sono state confrontate con quelle ottenute
in una popolazione di 40 pazienti sottoposti a confezionamento di AUV mediante impiego della tecnica
tradizionale Van Velthoven con sutura Vycril 2/0 dallo stesso operatore nello stesso arco di tempo. Il
confronto è stato eseguito mediante analisi per dati appaiati. L’appaiamento è stato eseguito per le seguenti
variabili: età, Antigene Prostatico Specifico (PSA),grado istologico,volume prostatico, indice di massa
corporeo (BMI).
Risultati
Tutti gli interventi sono stati eseguiti mediante tecnica extraperitoneale. Le caratteristiche pre-operatorie,
intra-operatorie e post-operatorie relative alle due popolazioni oggetto di studio sono riportate nella Tabella
1.
Discussione
Il confezionamento dell’ AUV costituisce un tempo chirurgico cruciale in corso di prostatectomia radicale. I
presupposti di una corretta guarigione includono: una corretta approssimazione dei margini, una omogenea
distribuzione delle tensioni e la tenuta stagna dell’anastomosi stessa. L’evenienza di leakages urinosi perianastomotici richiede prolungati tempi di cateterizzazione e può talora esitare in ascessi pelvici e stenosi
anastomotiche. Il dispositivo Filbloc® è una sutura sintetica monofilamento dentellata autobloccante a
lungo riassorbimento (180-210 giorni) caratterizzata da dentellature che si estendono fino all’estremità del
filo. Essa consente di agevolare l’esecuzione dell’anastomosi garantendo una omogenea distribuzione della
tensione lungo l’intera lunghezza dell’anastomosi ed una migliore approssimazione dei margini. Riportiamo
per la prima volta i risultati dell’impiego della sutura Filbloc® per il confezionamento dell’ AUV in corso di
LRP.
Conclusioni
L’impiego della sutura Filbloc® per il confezionamento dell’AVU offre vantaggi in termini di durata del
confezionamento della sutura, minore incidenza di leakage anastomotici e ridotti tempi di cateterizzazione.
72
73
P 72
P 73
COST-EFFECTIVENESS ANALYSIS OF MONEY-SAVING PROCEDURES IN ROBOT-ASSISTED
UROLOGIC SURGERY
CURVA DI APPRENDIMENTO “MODULARE” NELLA PROSTATECTOMIA RADICALE
ROBOTICA VALUTAZIONE E CONSIDERAZIONI SULLA NOSTRA ESPERIENZA
F. Scipioni, F. Lanzi, N. Tosi, F. Gentile, F. Cecconi, G. Pizzirusso, A. Canale, G. De Rubertis, G. Barbanti
(Siena)
C. Ambruosi, M. Mediago, G. Chiapello, F. Sommatino, E. Galletto, O. Maugeri, F. Venzano, D. Bernardi,
C. Dadone, G. Oppezzi, G. Arena (Cuneo)
Scopo del lavoro
The aim of this study is to evaluate the financial implications of minimally invasive surgery such as robotic
radical prostatectomy (RRP) and renal robotic tumoral enucleation (RTE) performed as standard techniques
or as a money-saving procedures and to compare functional and oncological results
Scopo del lavoro
Stiamo assistendo ad una crescente diffusione della prostatectomia radicale robotica (RARP). La maggior
parte degli studi valutano la curva di apprendimento per il singolo operatore. Il training di tipo modulare è
ritenuto da alcuni autori vantaggioso nell’abbattimento della curva di apprendimento. Nel presente studio
abbiamo valutato la nostra esperienza di equipè nella curva di crescita della RARP applicando un metodo di
apprendimento modulare.
Materiali e metodi
From April 2011 to January 2014 149 patients underwent robotic surgery for prostate (84 patients) and
renal cancer (65 patients). We identified the first set of patients treated after the initial learning curve(Group
A) and the latest ones (Group B) of each procedure. The first 8 prostatectomies and the first 5 tumoral
enucleations were performed following the standard procedures and adopting the prescribed instrumentation.
During our experience we redefine the procedures excluding from operating kits some tools to minimize
costs. In the present study we compared costs and surgical outcome of the first set of patients to the latest
one. Technical features of prostatic and renal surgery are summarized in table 1 and 2 respectively
Risultati
Instrumentation costs of both, radical prostatectomy and tumoral enucleation, resulted significantly lower
in the last 20 procedures: 2577€ Vs 4961€ for RRP and 2457€ Vs 4836€ for RTE, saving the48% and the
49.2% respectively (Tab 1-2). Mean (range) operating time for RRP in Group A was 208.4(160-265) minutes
Vs 168.3 (142-170) minutes of Group B (p=0.0041). Both groups of RRPs resulted similar in intraoperative
blood loss (p=0.482), histopatologically-confirmed positive surgical margins (p=0.089) and hospitalization
(p=0.195). Regarding RTE mean (range) operating time for RTE in Group A was 110.6 (70-165) minutes
Vs 98 (80-140) minutes of Group B (p=0.5151); intraoperative blood loss and hospitalization resulted
comparable (p=0.487 and p=0.379 respectively). In both groups there were not found positive surgical
margins, while in Group B it was discovered a peritumoral pseudocapsule incision
Discussione
This study should be considered a step in driving down costs of Da Vinci-assisted surgery by reducing
the number of laparoscopic and robotic surgical instruments and adjusting the relative passages of each
procedures. Technical difficulties in using less tools are resulted limited to the very first interventions. Our
instrumentation expedients determined a saving up to 49.1% for each single procedure. In our experience
intraoperative blood loss, operative time, intra and postoperative complications, hospitalization and the
finding of histopatologically positive surgical margins resulted comparable to the standard procedures
Materiali e metodi
Da giugno 2013 a febbraio 2014 sono state eseguite 40 RARP secondo la tecnica di Patel utilizzando
un sistema Da Vinci a quattro bracci. I pazienti selezionati erano tutti a basso rischio con un rischio di
coinvolgimento linfonodale
Risultati
Tutti gli interventi sono stati completati per via robotica. Nel 37% (15 pz) è stata eseguita una tecnica
nerve sparing bilaterale, nel 32% (13 pz) monolaterale. La durata media dell’ intervento è stata di 230 min,
tempo di console medio 190 min. Abbiamo avuto un caso di Clavien 3 e uno Clavien 2. Tempo medio di
cateterizzazione 4.5 gg (4-8). Alla rimozione del CV il 47% (19 pz) era continente (0 pad). A 1 mese dalla
rimozione del catetere il 79% era continente. Dei 31 pazienti potenti preoperatoriamente (IIEF 5 >21),
il 22% (7 pz) ha avuto erezioni spontanee a 1 mese. Il tasso di margini positivi è stato del 25% (10 pz).
Abbiamo avuto 15% di T3a (6 pz).
Discussione
Lo svolgimento di una curva di apprendimento di tipo modulare ha consentito di formare
contemporaneamente due equipè in un numero contenuto di interventi.
Conclusioni
Questo tipo di apprendimento consente di standardizzare meglio la tecnica e accellerare la crescita
dell’intera equipè.
Conclusioni
Our money-saving procedures, compared with conventional robotic radical prostatectomy and robotic
nephron sparing surgery, determined a saving up to 49.1% for each single intervention with intraoperative
blood loss, operative time, intra and postoperative complications, hospitalization and the finding of
histopatologically positive surgical margins resulted comparable to the standard procedures.
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75
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P 75
IMPACT OF SURGICAL VOLUME ON SURGICAL MARGIN STATUS IN PATIENTS TREATED
WITH ROBOT-ASSISTED RADICAL PROSTATECTOMY
Multi-institutional validation of the ERUS Robotic Surgery Training Curriculum
E. Di Trapani, G. Gandaglia, N. Fossati, M. Bianchi, R. Lucianò, M. Freschi, R. Bertini, A. Salonia, V.
Mirone, F. Montorsi, A. Briganti (milano)
Aim of the study
Previous studies showed a role of surgical experience on the surgical margin status in patients treated with
open radical prostatectomy (ORP), where individuals treated by less experienced surgeons were at higher
risk of having positive surgical margins (PSM) at final pathology. However, evidence is scarce regarding the
role of surgeon experience on the surgical margin status in prostate cancer (PCa) patients receiving robotassisted radical prostatectomy (RARP).
Overall, 1,156 patients with PCa treated with RARP between February 2006 and August 2013 by four
most experienced surgeons at a single tertiary referral center were identified. All patients had available
preoperative and pathological data. Surgical volume was coded as the number of robotic cases done by
the surgeon before the index patient’s operation. Two multivariable logistic regression models were fitted
to assess the impact of surgical volume on the risk of positive surgical margins. The first model included
preoperative covariates, namely clinical stage, biopsy Gleason score, and PSA at surgery. The second model
included pathological data, such as pathological stage, pathological Gleason score, and nerve-sparing status.
Results
Mean patient age was 62.5 years (median: 63). Mean surgical volume was 194 (median: 190). Overall, 178
patients (15.4%) had PSM at final pathology. When patients were categorized according to pathological
stage, the rate of PSM was 9.0, 38.3, and 45.2% in patients with pT2, pT3a, and pT3b/pT4 disease,
respectively (P
Discussion
In patients treated with RARP, surgeon experience is an independent predictor of the surgical margin status.
Particularly, patients treated by more experienced surgeons are at lower risk of PSM at final pathology.
Conclusions
These findings highlight the role of the learning curve phenomenon typical of early adopters in the context
of robotic surgery.
76
Alessandro Volpe1-2, Kamran Ahmed3, Prokar Dasgupta3, Vincenzo Ficarra1-4, Henk van der Poel5, Alexandre
Mottrie1 and the ERUS board members
BACKGROUND: The criteria set for surgeon’s competence before starting robotic surgery are neither
structured nor evidence based. The development of structured and validated training curricula represents one
of the current priorities in the robotic urologic field.
METHODS: A structured training program/curriculum was developed based on a focused group expert panel
discussion (ERUS 2012/13; EAU 2013) and used to train 10 fellows from major teaching institutions across
Europe. The overall study duration was 12 weeks. The key components of the curriculum included e-learning,
an intensive week of structured simulation laboratory training, including virtual reality simulator and dry/
wet lab simulation platforms (synthetic, animal and cadavers) and modular training in robot-assisted radical
prostatectomy (RARP) at each institution under supervision of the mentors. The basic robotic skills of the
fellows were assessed with in-built, validated objective assessment tools at the daVinci surgical simulator
system (daVss) at baseline, at the beginning and at the end of the intensive week of laboratory training (week
4 of the training period) and at the end of the program. The performance scores at each time point were
compared. The technical and non- technical skills of the fellows were assessed by the mentors at the end of
the program using previously validated GEARS (score 1- 5) and NOTTS (score 1-4) scales. Following the
completion of the simulation based curriculum-training, a full RARP performed by the fellows was videorecorded and blindly assessed by two independent expert robotic surgeons using a dedicated assessment scale.
The scores of the fellows were compared with those of two expert robotic surgeons. The educational impact
was evaluated with a questionnaire the fellows had to complete at the end of the training.
RESULTS: The fellows had limited previous console exposure (4 mos, IQR 0-6.5). The scores achieved by
the fellows at the daVss at the end of the 12-weeks training program were significantly higher than the baseline
scores for all simulation exercises (p<0.0001 for Ring walk 3, Match board 2, Energy switch 2, Dots and
needles 1 and Tubes; p=0.006 for Suture sponge 2; p=0.031 for Thread the rings). At the end of the training,
the fellows received an average score >4 (4.1-4.7) from their mentors for all the technical skills domains of the
GEARS scale, with no negative scores (≤2). An average score ≥3.5 was also achieved for the 4 non-technical
skills domains of the NOTTS scale, with no negative scores (≤2). Eight fellows were deemed able to perform
a RARP alone by their mentors. At the assessment of the video-recorded RARP, 6 fellows received a sufficient
score by the reviewers for all steps of the surgical procedure and 8 reached an average overall sufficient score.
The robotic experts significantly outperformed the fellows for all surgical steps. At the final questionnaire, all
fellows considered the program effective in improving their robotic skills and ability to perform the surgical
steps of RARP with a mean score 4.7 on a Likert-type scale (1=strongly disagree to 5=strongly agree).
CONCLUSIONS: This 12-weeks structured training program was successful to improve the robotic skills of
fellows and their ability to perform the surgical steps of RARP. Further studies are needed to define the ideal
length and schedule of these programs. This pilot study represents a step towards the definition of validated
curricula for RARP and other robotic procedures.
77
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PERIOPERATIVE, PATHOLOGICAL AND FUNCTIONAL OUTCOMES OF ROBOTIC RADICAL
PROSTATECTOMY: 500 CONSECUTIVE CASES WITH A MINIMUM 12 MONTH FOLLOW-UP
PREDICTORS OF EARLY COMPLICATIONS IN PATEINTS SUBMITTED TO ROBOTICASSISTED RADICAL PROSTATECTOMY. A SINGLE-INSTITUTION ANALYSIS.
G. D’Elia, P. Emiliozzi, A. Iannello, A. Cardi, A. De Vico, B. Tassi, T. Riga, A. Scapellato (Roma)
G. Lista, G. Lughezzani, A. Gallina, N. Fossati, P. Dell’Oglio, N. Buffi, A. Abrate, A. Larcher, G. Gadda , N.
Suardi, G. Guazzoni (Milano, Specializzando)
Aim of the study
This study examines perioperative, pathological and functional outcomes as well as complications of robotic
radical prostatectomy at a large community-setting center with a quality assurance program.
Perioperative data and functional and pathological results of 500 consecutive patients who underwent
robotic radical prostatectomy were prospectively collected. Perioperative outcome measures included:
operative time, estimated blood loss, transfusion rate, complication rate according to modified Clavien
system, median hospital stay, mean catheterization time. Pathologic outcome measures encompassed
positive surgical margin rate and biochemical recurrence free survival (PSA < 0.2). Return of continence
was evaluated at 1, 3, 6 and 12 months (continent 0 pads; incontinent 1 or more pads). Return of potency
was evaluated at 1, 3, 6 and 12 months with IIEF-5 scores in 402 patients who underwent a nerve-sparing
procedure (mean age 61 years; range 36 - 70).
Results
Mean age was 64.1 years (36-73). Mean body mass index (BMI) was 26.6. Median preoperative PSA
level was 6.9 ng/ml. Mean operative time was 146 minutes. Mean estimated blood loss was 160 cc. Blood
transfusion was needed in 8 patients. Median hospital stay was 3 days, mean catheterization time was 8.1
days. According to the modified Clavien system, grade III complication rate was 2.6 %, whereas minor
complication rate was 17 %. Positive surgical margin rate was 12.8 % for pT2 disease and 29 % for pT3
disease. Overall biochemical recurrence free survival is 95%. Complete continence at 1, 3, 6, and 12 months
was 57%, 88%, 94% and 98%, respectively. Mean age of the 402 patients who underwent a nerve-sparing
procedure was 61 years (range 36-69). At 1, 3, 6 and 12 months return of potency (IIEF-5 > 21) with or
without the use of oral medications was achieved in 6%, 22%, 51% and 68%, respectively.
Discussion
Robotic radical prostatectomy has a low perioperative complication rate and acceptable outcomes in terms
of positive surgical margins and maintenance of urinary continence and erectile function.
Conclusions
Robotic radical prostatectomy has a low perioperative complication rate and acceptable outcomes in terms
of positive surgical margins and maintenance of urinary continence and erectile function.
Scopo del lavoro
Robotic assisted radical prostatectomy (RARP) represents a widely adopted treatment for patients with
clinically localized prostate cancer (PCa). However, only few series have shown the detailed complication
rates of such surgical approach. We analysed the prevalence and risk factors of early post-operative
complications in a large population of consecutive patients treated with RARP in a single institution.
Materiali e metodi
Between 2006 and 2013 three surgeons performed RARP in 1200 consecutive patients with localised
PCa. Early (30 day) post-operative complications were recorded and classified according to the ClavienDindo classification system. Patients overall health status was evaluated through the American Society of
Anesthesiology (ASA) score system. Preoperative oncological characteristics such as total PSA, biopsy
Gleason score and clinical stage were stratified according to D’Amico risk categories. Surgical expertise
was coded as the progressive number of cases performed by each surgeon. Univariable and multivariable
logistic regression analyses were performed to predict risk factors of early post-operative complications.
Covariates consisted of age, BMI, ASA score, D’Amico risk group, surgical expertise, the occurrence of
pelvic lymphadenectomy and the adoption of a nerve-sparing (NS) technique.
Risultati
Mean age was 62.5 years (median:63, IQR:58-68). Mean BMI was 25,7 (median:25,3; IQR:23,7-27,6) .
392 (32,7%), 751 (62,6%) and 57 (4,8%) patients had low, intermediate and high risk disease, respectively.
ASA score distribution was 1 in 392 (32,7%), 2 in 751 (62,6%), 3 in 56 (4,7%) and 4 (0,1%) in 1 patient,
respectively. Nerve-sparing technique and pelvic lymphadenectomy were performed in 1049 (87%) and
847 (71%) patients, respectively. Early postoperative complications were reported in 149 patients (12%).
Clavien grade I, II, IIIa, IIIb and IV complications were 2.9 (n=35) , 7 (n=85), 0.5 (n=6), 1.6 (n=19)
and 0.3% (n=4) respectively. Most common early complications were anemization (n=57; 4.8%), pelvic
hematoma (n=23; 1,9%) lymphorrea (n=15; p=1,3%), hyperpyrexia (n=17; 1,4%) and urinary leakage
(n=6; 0,5%), respectively. Laparotomy for bleeding and hematoma drainage was necessary in 14 cases
(1%) while 5 patients (0,3%) were re-operated for bowel occlusion or perforation. At multivariable
analysis, after adjusting for age, severity of disease, BMI and nerve-sparing technique, patient ASA score
(OR:1.4; p=0.02), and surgical expertise (OR: 0.99; p=0.02) represented independent predictors of early
complications.
Discussione
RARP represents a safe surgical approach for clinically localized PCa, despite early post-operative
complications can be expected in 12% of patients in high volume centers. Patients with more comorbidities
are more exposed to the risk of early complications. There is a reduction in the complication rate with
increasing surgical expertise.
Conclusioni
RARP represents a safe surgical approach for clinically localized PCa
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79
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RICOSTRUZIONE MUSCOLO FASCIALE ANATOMICA COMPLETA E CONTINENZA
PRECOCE DOPO PROSTATECTOMIA RADICALE: RISULTATI DI UNA TECNICA
PERSONALE
SIMULAZIONE IN LAPAROSCOPIA 3D VS 2D, ANALISI DEI TEMPI E
DELL’APPROPRIATEZZA DI ESECUZIONE IN UN’AMPIA COORTE DI SENIOR
RESIDENTS DEL PROGRAMMA EUREP (EUROPEAN UROLOGY RESIDENCY EDUCATION
PROGRAMME)
C. Fiori, I. Morra, S. Grande, M. Poggio, F. Ragni, M. Manfredi, R. Bertolo, F. Mele, D. Garrou, D.
Amparore, G. Cattaneo, R. Aimar, F. Porpiglia (Orbassano)
Scopo del lavoro
L’incontinenza urinaria è uno dei principali effetti indesiderati della prostatectomia radicale (RP).
Sebbene la percentuale di incontinenza ad un anno sia notevolmente diminuita nelle casistiche più recenti,
l’incontinenza precoce rappresenta ancora un problema significativo per il paziente. Allo scopo di favorire
un più precoce ritorno alla continenza Rocco e coll. hanno descritto una tecnica di ricostruzione del piatto
muscolo-fasciale posteriore dopo prostatectomia radicale. Successivamente numerose modifiche sono state
apportate a tale tecnica. Scopo di questo studio è quello di presentare una tecnica personale di ricostruzione
muscolo fasciale anatomica “completa” (-total anatomical reconstruction TAR-) in corso di RP robot
assistita (RARP) e valutarne l’impatto sulla continenza precoce.
Materiali e metodi
Sono stati rivisti retrospettivamente i dati del nostro “RARP database” mantenuto prospetticamente. Sono
stati estratti i dati relativi a 112 pazienti consecutivi (gruppo A) trattati nel 2013 in cui è stata eseguita
la TAR ed i dati di 112 pazienti consecutivi (gruppo B) trattati nello stesso periodo del 2012 in cui è
stata eseguita la sola ricostruzione posteriore secondo tecnica tradizionale descritta da Rocco. Sono stati
confrontati i dati demografici, perioperatori, il tempo di cateterizzazione e le complicanze. Infine sono state
confrontate le percentuali di continenza alla rimozione del catetere vescicale, dopo 48 ore, a 1 e 3 mesi
dalla rimozione del catetere. Tecnica operatoria, gruppo A. Dopo aver completato la fase demolitiva della
procedura, si procede a ricostruzione del piatto posteriore in triplice strato mediante la medesima sutura
continua in V lok 3/0: 1) sutura fra il tessuto rafe mediano ed la fascia di Denonviller 2) sutura fra il rafe
mediano e la fascia retrotrigonale 3) sutura (extramucosa) fra l’uretra e il collo vescicale, piatto posteriore.
Al termine dell’anastomosi uretro – vescicale, ricostruzione anteriore in sutura continua Vlok 3/0: 4) fra
l’uretra e il collo vescicale (extramucosa, piatto anteriore) e 5) ricostruzione dell’apron.
Risultati
I due gruppi sono risultati sovrapponibili in termini di variabili demografiche e perioperatorie. Le percentuali
di continenza nel gruppo A vs B sono risultate 66% vs 62,5 %(p=0.5) alla rimozione del catetere, 77,6% vs
57,1% (p
Discussione
Recentemente, gli sforzi dei chirurghi durante la RARP sono rivolti al miglioramento dei risultati funzionali,
in particolare al miglioramento della continenza, anche precoce. In questo scenario numerose tecniche sono
state proposte. Nell’ambito di queste tecniche riteniamo che la TAR consenta un significativo miglioramento
funzionale.
Conclusioni
I risultati della nostra esperienza dimostrano, pur con i limiti imposti dalla limitata numerosità campionaria,
che la TAR migliora significativamente la continenza immediata e precoce senza inficiare la sicurezza della
procedura.
80
G. Siena, A. Minervini, D. Veneziano, A. Tuccio, G. Vittori, B. Van Cleynenbreugel, A. Gözen, J. Beatty, .
Langenhuijsen, D. Bochove-Overgaauw, S. Serni, M. Carini (Firenze)
Scopo del lavoro
Valutare la correttezza e i tempi di esecuzione (TE) di un esercizio standardizzato di coordinazione e
destrezza bimanuale eseguito al pelvi trainer laparoscopico mediante videocamera 2D vs 3D in una coorte di
senior residents (SRs).
Materiali e metodi
Dal 2010 al 2013, nell’ambito del corso EUREP (European Urology Residency Educativo Programme),
patrocinato dall’EAU (European Association of Urology), abbiamo registrato la correttezza ed i TE di
un esercizio di simulazione al pelvi-trainer laparoscopico mediante l’utilizzo della visione 2D e 3D, in
un’ampia coorte di SRs. Con l’ausilio di pinze Johan laparoscopiche il SR deve far passare una barra
metallica di circa 8x4 cm, composta da 3 quadrati saldati su piani sfalsati di 90°, attraverso una sottile
fenditura fissata in posizione verticale (figura 1). La riuscita dell’esercizio prevede il completo passaggio
della barra da sinistra verso destra, attraverso la fenditura. L’esercizio combina destrezza bimanuale,
coordinazione mano-occhio e finezza dei movimenti. I SRs che hanno superato correttamente la prova sono
stati suddivisi in 3 sottogruppi in base al livello di esperienza in laparoscopia e al TE: novices, intermediates
e skilled. L’analisi con Chi-quadrato è stata utilizzata per valutare differenze statisticamente significative tra
i gruppi 2D vs 3D suddivisi nei vari sottogruppi.
Risultati
49 SRs e 57 SRs hanno superato correttamente l’esercizio con l’utilizzo della visione 2D e 3D,
rispettivamente. Complessivamente, la mediana dei TE nel gruppo 3D vs 2D è risultata significativamente
più veloce: 29 (6-109) vs 52 (10-305) secondi (CI 90%; p=0.01). Andando a valutare i TE nei 3 sottogruppi,
l’utilizzo della visione 3D ha portato ad una significativa riduzione dei TE dell’esercizio. Nel sottogruppo
skilled la mediana dei TE è stata 14 vs 15.7 (p=0.04) secondi; nel sottogruppo intermediates di 38 vs
60.4 (p=0.08) secondi; nel sottogruppo novices 52 vs 84.7 (p=0.04) secondi, per il gruppo 3D vs 2D
rispettivamente.
Discussione
Il limite principale per chi si accinge alla laparoscopia tradizionale è rappresentato dalla visione
bidimensionale e dall’angolo di incidenza obbligato degli strumenti laparoscopici. Il superamento di tali
limitazioni avviene con l’esperienza ed il training continuo sia ai simulatori e successivamente in sala
operatoria. L’utilizzo della visione 3D facilita la coordinazione mano-occhio e la finezza dei movimenti.
Questo può risultare necessario sia nelle fasi iniziali della curva di apprendimento che a livelli più avanzati.
Conclusioni
L’utilizzo della visione 3D in video laparoscopia in una coorte di senoir residents ha portato ad una
significativa riduzione dei tempi di esecuzione di esercizi di simulazione al pelvi-trainer che prevedono
destrezza bimanuale, coordinazione mano occhio e finezza dei movimenti, sia in chirurghi naives che ad un
livello più avanzato, con possibili concreti effetti in un campo operatorio reale.
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P 80
P 81
THE IMPACT OF PREVIOUS PROSTATIC SURGERY ON LAPAROSCOPIC RADICAL
PROSTATECTOMY: EFFECTS ON SURGICAL, ONCOLOGIC AND FUNCTIONAL
OUTCOMES.
THE USE OF BIDIRECTIONAL BARBED SUTURE DURING ROBOTIC ASSISTED RADICAL
PROSTATECTOMY: IMPACT ON THE PERIOPERATIVE AND FUNCTIONAL OUTCOMES.
P. Verze, S. Scuzzarella, F. Bottone, F. Greco, C. Sciorio, C. Imbimbo, V. Mirone (Napoli)
Aim of the study
to assess the effects of previous prostatic surgery (PPS) on the surgical, oncologic and functional outcomes
of a large series of LRP.
946 consecutive men underwent LRP for localized prostate cancer by the same surgical team. Included
in this group were 98 patients (10.3%) with a history of prostatic surgery for BPH treatment, including
monopolar TURP, laser TURP and simple prostatectomy. The preoperative, intraoperative, postoperative
and oncologic follow-up data were collected in a prospectively-maintained database, while a retrospective
comparison between patients with a history of prostatic surgery (group A) and those without (group B) was
made.
Results
TURP was the most frequently performed prostatic surgery before LRP in 81 cases, followed by laser TURP
(HoLEP) in 11 cases and simple prostatectomy in 6 cases. Longer operative time, greater blood loss, longer
catheterization time and higher incidence of lymphocele, rectal injury and anastomotic stricture were found
in group A patients. The positive surgical margin rate was slightly increased, although not in a statistically
significant way, in group A patients with pT3a and pT3b stages. No statistically significant difference was
noted between the two groups in terms of BCRFS. Complete urinary continence rate resulted significantly
higher in group B patients at both 1-year and 2-year follow-up. Similarly, potency rate resulted better in
group B patients with a significant difference for both unilateral and bilateral nerve sparing technique at 2
year follow-up but not at 1-year follow-up.
Discussion
The effect of previous TURP on open radical prostatectomy and LRP is still much debated. Compared
to previously published articles that considered only TURP operations, our study also includes cases of
laser TURP (HoLEP) and simple prostatectomies. Based upon our experience, the type of PPS did not
have any impact on LRP, with the exception of making it more difficult to access the Retzius space in PPS
patients who had undergone simple prostatectomy, due to the adhesions induced by the sutures of bladder
and abdominal walls. With regards to intra-operative data, based upon our experience, worse results were
observed in PPS patients with a statistically significant difference in terms of operative time and mean blood
loss. A significantly longer catheterization time in patients with previous prostatic surgery was observed in
the post-operative data, while no difference between the two groups for mean hospital stay was found
B. Rocco, E. De Lorenzis, K. Palmer, S. Pigilam, S. Samavedi, H. Abdul Mushin, V. Patel (Milano)
Scopo del lavoro
Bidirectional barbed self-retaining sutures represent a new advancement in the application of suture
materials used in reconstructive urology. This analysis represents our preliminary effort to examine the
intraoperative, postoperative and intermediate functional outcome of bidirectional sutures during robot
assisted radical prostatectomy (RARP).
Materiali e metodi
Between January 2008 and December 2010, 2168 RARP procedures were performed at our institution by a
single surgeon (VP). In this cohort there were 97 patients in whom a bidirectional-barbed suture (AngiotechQuill™) was used for bladder neck reconstruction, posterior reconstruction and urethrovesical anastomosis
(Group 1). These 97 patients were then computer-matched using multivariable analysis to those who did
not undergo bidirectional-barbed suture during the procedure (Group 2). Retrospective analysis of the
perioperative and functional outcomes was conducted.
Risultati
There were no differences between the preoperative clinical and demographic variables between the two
matched groups. The anastomosis subjectively evaluated by the surgeon was easier in the group 1 (
Discussione
barbed suture have been recently introduced with the aim of make it easier for the surgeons to perform
sutures, particularly anastomosis. Also in the hands of an experienced and skilled operator, barbed suture
make sutures faster.
Conclusioni
Usage of bidirectional barbed suture during RARP results in easier and quicker urethrovesical anastomosis
and in a lower incidence of radiologic urinary leakage. These preliminary results are encouraging and
provide the impetus to conduct further studies with an increased sample size to more clearly define the
outcomes in the use of Quill bidirectional barbed suture.
Conclusions
LRP procedure can be safely performed on patients who have undergone previous prostatic surgery without
compromising oncologic safety whereas a negative impact on functional outcome in terms of complete
urinary continence rate and sexual potency is likely. Longer operative time, greater blood loss, longer
catheterization time and higher incidence of lymphocele, rectal injury and anastomotic stricture can be
expected.
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P 83
A PROSPECTIVE, MULTICENTER EVALUATION OF PREDICTIVE FACTORS FOR
POSITIVE SURGICAL MARGINS AFTER NEPHRON SPARING SURGERY FOR RENAL CELL
CARCINOMA: THE RECORD1 ITALIAN PROJECT.
CARATTERISTICHE ANATOMO-PATOLOGICHE E PROGNOSTICHE DELLE NEOPLASIE
RENALI CANDIDABILI A SORVEGLIANZA ATTIVA: STUDIO RETROSPETTIVO SU 650
PAZIENTI SOTTOPOSTI AD INTERVENTO CHIRURGICO
R. Schiavina, S. Serni, A. Mari, A. Antonelli, R. Bertolo, G. Bianchi, E. Brunocilla, M. Borghesi, M. Carini,
N. Longo, G. Martorana, V. Mirone, G. Morgia, F. Porpiglia, B. Rocco, B. Rovereto, C. Simeone, M.
Sodano, C. Terrone, V. Ficarra, A. Minervini (Bologna)
M. Furlan, A. Antonelli, M. Sodano, G. Galvagni, T. Zanotelli, A. Cozzoli, C. Simeone (Brescia)
Aim of the study
Nephron-sparing surgery (NSS) has become the standard of care for the conservative management of
clinically localized renal cell carcinoma (RCC) whenever technically feasible. The excision of the tumor
with a minimal margin of healthy parenchyma surrounding the neoplasm is currently considered the standard
technique for NSS, in order to minimize the risk of positive surgical margins (PSMs) and achieve optimal
local cancer control. We aimed to evaluate the predictors of PSMs after NSS for RCC in one of the largest
available prospective multi-institutional study.
The Italian Registry of Conservative Renal Surgery (RECORd Project) includes all patients who underwent
conservative surgical treatment for radiologically diagnosed kidney cancers between January 2009
and December 2012 at 19 urological Italian centers. All preoperative anthropometric characteristics,
intraoperative and pathological data were collected. Postoperative complications (within 30 days from
surgery) were recorded. Standard partial nephrectomy (PN) has been defined as the excision of the tumor
comprising a minimal margin of healthy peritumoral renal parenchyma. Simple tumor enucleation (SE) has
been defined as the blunt tumor excision without removing a visible rim of parenchymal tissue around the
pseudocapsule. Multivariable logistic regression models considering factors that were significantly related to
SM status at univariable analysis were applied to analyse predictors of PSM.
Results
Eight hundred consecutive patients were evaluated. 761 (95.1%) and 39 patients (4.9%) achieved negative
and positive surgical margins, respectively. Patients with PSMs were significantly older compared to those
with negative margins (median age: 66.6 vs. 61.8 years, respectively, p=0.001). No statistically significant
differences were found among patients with positive and negative margins in terms of gender, BMI,
indication to NSS (elective/relative vs. imperative), symptoms at the time of diagnosis, ECOG performance
status, number of lesions, clinical stage and tumor side. A higher incidence of PSMs was observed when
NSS was performed for renal masses located in the upper pole (p=0.001). A lower rate of PSM was found
in those patients treated with simple enucleation rather than standard partial nephrectomy (1.6% vs. 7.4%
respectively, p
Discussion
.
Conclusions
The early oncological goal of PN is to achieve negative margins. In our multi-institutional report of open and
minimally invasive NSS, the overall rate of PSM is 4.9%. Young age, SE, middle or lower tumor location
and low grade tumor are all independent predictors of NSMs.
84
Scopo del lavoro
La sorveglianza attiva trova indicazione nel management delle piccole masse renali (SRM), in pazienti
anziani o con gravi comorbidità. Questo studio analizza le caratteristiche patologiche, gli esiti chirurgici e la
prognosi di un’ampia coorte di casi operati, ma candidabili a sorveglianza.
Materiali e metodi
Analisi retrospettiva di un database istituzionale compilato prospetticamente dal 1983 ad oggi, che archivia i
dati di 2300 pazienti trattati per neoplasia renale. Le comorbidità sono espresse con il Charlson comorbidity
score. Due uropatologi esperti hanno valutato i preparati istologici. La stadiazione ha seguito il TNM 2002.
Il grading secondo Fuhrman è stato assegnato solo ai carcinomi a cellule chiare. Le complicanze postoperatorie sono classificate secondo il sistema di Clavien. Per il presente studio sono stati analizzate SRM in
stadio cT1a N0 M0, asintomatiche. E’ stata compiuta un’analisi separata della mortalità legata al carcinoma
renale e di quella legata a cause indipendenti da esso, applicando un modello di regressione di Cox.
Risultati
Sono stati inclusi 645 pazienti (415 M, 230 F, età media 62.9+/-11.2 anni); il Charlson score era 0 in 312
casi, 1 in 99, 2 in 82 e 3 o superiore in 30. 179 pazienti sono stati sottoposti a nefrectomia radicale, 466 a
nefrectomia parziale, di cui 59 con indicazione di necessità; nel decorso post-operatorio non vi sono state
complicanze per 487 casi, complicanze Clavien 1 in 46, 2 in 82 3 o superiori in 30. Nella tabella vi sono i
dati della valutazione patologica. Il follow up medio è stato di 5.6 anni (range interquartile 2.3-10.0 anni).
Una progressione si è verificata in 37 casi (6.7% dei maligni); Deceduti per neoplasia renale 19 pazienti
(3.4% dei maligni), per altre cause 76 pazienti (11.8% del campione). L’unico fattore che all’analisi
multivariata ha dimostrato una correlazione indipendente con il rischio di progressione è stato il grado 3-4
(RR 2.543, 95% CI 1.227-5.272, p=0.012). I fattori correlati con il rischio di morte per altre cause sono stati
l’età (RR 1.077, 95% CI 1.047-1.107, p
Discussione
Nei pazienti con SRM candidabili a sorveglianza attiva: 1) il trattamento può essere conservativo 2) il
rischio di complicanze è del 25%, spesso di grado minore 2) la maggioranza delle SRM sono maligne 3) il
25% di questi casi ha un grading elevato ed è più esposto ad un basso rischio di mortalità causa specifica
4) la mortalità non cancro correlata è 4 volte superiore a quella causa specifica e dipende dall’età e dalle
comorbilità.
Conclusioni
La conoscenza preliminare del grading nei pazienti di età superiore a 65 anni e con Charlson score pari a 2
permetterebbe di valutare meglio rischi e benefici della chirurgia delle SRM.
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P 85
DECREASING RATES OF LYMPH NODE DISSECTION AND LYMPH NODE YIELD DURING
RADICAL NEPHRECTOMY FOR RENAL CELL CARCINOMA OVER THE LAST 30 YEARS IN
A LARGE MULTICENTRE EUROPEAN EXPERIENCE
FINO A QUANDO E’ GIUSTIFICATO IL FOLLOW UP DEI PAZIENTI CON CARCINOMA
RENALE? ANALISI DI UNA COORTE DI 550 PAZIENTI CON ALMENO 10 ANNI DI
CONTROLLI.
L. Zegna, C. Terrone (Novara)
A. Antonelli, M. Furlan, M. Sodano, G. Galvagni, T. Zanotelli, A. Cozzoli, C. Simeone (Brescia)
Aim of the study
The value of lymph node dissection (LND) in patients with renal cell carcinoma (RCC) still remains
controversial. The lack of a proven benefit has led many urologists to reduce the indications for LND in
the clinical setting. When LND is performed, there is evidence that a minimum of 12-15 nodes should be
removed to achieve an adequate staging. Aim of this study was to assess the changes in LND rate and nodal
yield during radical nephrectomy (RN) during the last 3 decades in a large, multicentre European dataset.
Scopo del lavoro
E’ opinione diffusa che dopo 5-10 anni di controlli senza evidenza di recidive possa essere interrotto
il follow up dei pazienti operati per carcinoma renale, anche se in letteratura vi sono pochissimi i dati
in merito. Presentiamo la nostra esperienza nei pazienti che hanno superato 10 anni di follow up per
descriverne l’evoluzione clinica e suggerire come condurre i controlli.
We retrospectively evaluated the clinical information of a prospectively maintained database including 2884
patients treated with RN at three European tertiary care centres between 1983 and 2012. We assessed the
change of LND rate over time by dividing patients in 6 groups according to the year of surgery (1983-7 vs.
1988-92 vs. 1993-7 vs. 1998-2002 vs. 2003-7 vs. 2008-12). We evaluated the temporal trend of the overall
LND rate and that of the rate of LNDs performed with different nodal yields (≥4 nodes and ≥12 nodes). The
association between the number of lymph nodes (LNs) removed and the year of surgery was also assessed.
Results
Among 2884 patients treated with RN in the study period, 1550 (53.7%) underwent a LND with removal of
a median of 7 LNs (IQR 4-12). 1207 (41.9%) and 429 (14.9%) patients had ≥4 LNs and ≥12 LNs removed,
respectively. There was a significant progressive reduction of the overall LND rate over time (80% in 198387 vs. 36% in 2008-12; p<0.001).
Discussion
Conclusions
The number of LNDs performed during RN has been significantly decreasing in the last 30 years, with a
stable rate in the last decade. The number of LNDs performed with an adequate LN yield for staging has
also been significantly decreasing, representing a potential quality of care concern.
Materiali e metodi
Consultazione retrospettiva di un database istituzionale compilato prospetticamente dal 1983 ad oggi, che
archivia i dati di oltre 2300 pazienti sottoposti ad intervento per neoplasia renale. Tutti i pazienti nel follow
up sono seguiti presso un ambulatorio dedicato, con scadenze ed accertamenti modulati in base allo stadio
patologico della malattia, in ogni caso per un periodo di tempo indefinito. Per il presente studio sono stati
rivalutati i dati dei pazienti con carcinoma renale, non metastatico alla diagnosi e seguiti per un periodo
minimo di follow up pari a 10 anni.
Risultati
Sono stati analizzati i dati di 554 pazienti (231 femmine, 323 maschi, età media 59.3+/-11.6 anni) operati tra
il Gennaio 1983 ed il Dicembre 2003 e seguiti per un periodo mediano di follow up pari a 15.1 anni (range
interquartile 11.2-18.1 anni). 131 casi erano stati sottoposti nefrectomia parziale, 423 a nefrectomia radicale;
il diametro mediano della neoplasia era di 5.1 cm (range interquartile 3.0-6.5 cm, con stadio patologico 1 in
386 casi (70.3%), 2 in 53 (9.7%), 3 in 104 (18.9%) e 4 in 6 (1.1%), grado 1 in 85 (16.1%), 2 in 301 (56.9%),
3 in 113 (21.4%) e 4 in 30 (5.7%) e istotipo a cellule chiare in 477 casi (86.1%), papillare in 40 (7.2%),
cromofobo in 27 (4.9%), altro in 9 (1.6%). La sopravvivenza libera da malattia stimata a 15 e 20 ani è stata
pari al 98.2% e al 96.0%. Si è osservato un evento di progressione in 29 pazienti (5.2%) ad un intervallo
mediano di 161 mesi (range interquartile 132-172 mesi). La sede di progressione è stata il rene controlaterale
in 10 casi (incidenza 1.8%), il polmone in 5 (0.9%), lo scheletro in 1 (0.2%), il fegato in 1 (0.2%), sedi
atipiche in 5 casi (0.9%), la loggia renale in 3 casi (0.6%), sedi multiple in 4 (0.7%). E’ stato applicato un
modello di regressione logistica per individuare i possibili predittori della progressione (vedi tabella). Lo
stadio patologico si è dimostrato come il fattore indipendentemente correlato al rischio di progressione;
questo è stato pari al 2.3%, 7.5%, 11.5% e 16.7% negli stadi 1, 2, 4 e 4 rispettivamente (p<0.001).
Discussione
Il rischio di una ripresa di malattia dopo intervento per carcinoma renale, trascorsi 10 anni di follow up
negativo, è pari al 5% circa. Tale rischio dipende dallo stadio patologico e si manifesta soprattutto con lo
sviluppo di neoplasie nel rene controlaterale o di metastasi polmonari.
Conclusioni
Possiamo quindi concludere che un follow up oltre i 10 anni è consigliabile solo nei casi con stadio
patologico superiore al primo.
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HAS THE NEW EDITION OF THE TNM IMPROVED THE LYMPH NODE STAGING FOR
RENAL CELL CARCINOMA?
IMPACT OF GENDER IN NEPHRON SPARING SURGERY: COMPARISON OF
PERIOPERATIVE OUTCOMES FROM THE DEFINITIVE RESULTS OF RECORD PROJECT
C. Terrone, U. Capitanio, A. Volpe, E. Di Trapani, R. Matloob, P. De Angelis, A. Russo, S. Tunesi, L. Zegna,
M. Fusano, A. Briganti, R. Bertini, F. Montorsi (Novara)
A. Mari, D. Villari, A. Antonelli, R. Bertolo, G. Bianchi, M. Borghesi, E. Brunocilla, M. Carini, N. Longo,
G. Martorana, V. Mirone, G. Morgia, F. Porpiglia, B. Rocco, B. Rovereto, R. Schiavina, C. Simeone, M.
Sodano, C. Terrone, V. Ficarra, S. Serni, A. Minervini (Firenze)
Scopo del lavoro
The most commonly used staging system of Renal Cell Carcinoma (RCC) is the Tumor-Node-Metastasis
system. In the last editions of this classification, lymph node (LN) involvement was defined independently
of the number of positive LNs (pN1: one or more positive LNs). Previously, there were pN1 and pN2
subcategories, identifying cases with one or more than one positive LNs, respectively. The aim of this study
was to evaluate the prognostic value of lymph node involvement taking into account the number of LN
removed and the number of positive lymph nodes.
Materiali e metodi
All the pathological reports of the radical nephrectomies for RCC performed in three Tertiary Care Centers
from November 1983 to December 2012, were reviewed. For each patient complete pathological data,
extension of lymphadenectomy, number of LNs removed, number of positive LNs and ratio between
number of positive LNs and total number of LNs (LN density) were recorded. The pathological stage was
determined according to the TNM seventh edition. Kaplan-Meyer method and log-rank test were used to
calculate the cause-specific survival rate and to compare the survival curves, respectively. Cox proportional
hazards regression model was used to determine the variables that were independently correlated with
cancer death.
Risultati
There were 2884 patients. Lymphadenectomy was performed in 1550 cases. The median age of these
patients was 60.0 years (range 21-88). Median follow period was 57.6 months. The rate of positive LNs was
13.3% (207/1550). Distant metastases at diagnosis were present in 96 out of 207 cases. The average number
of LNs removed was 7 (range 1-58). The median number of LNs involved was 3 (range 1-23). Limited
(hilar) lymphadenectomy was performed in 552 patients. The 5-year cause-specific survival rate of pN+
cases was 19.5%. There was no difference in 5-year cause-specific survival between patients with 1 positive
lymph node and patients with more than 1 positive LN (23% vs 18%; p=0.1). A significant difference was
only found in patients with distant metastases at diagnosis (16.5% vs 0%). Similar results were obtained
limiting the analysis to the patients submitted to complete lymphadenectomy. A number of LNs involved
greater than 4 better stratify the prognosis of cases with positive LNs, except in M0 patients. Lymph node
density had no prognostic impact. In patients with nodal involvement, the multivariable analysis showed an
independent prognostic value for pT, M and pN1-pN2 (HR 1.57;95% IC 1.06-2.31; p=0.01) but not for the
Fuhrman Grade.
Aim of the study
The aim of this study is to analyse gender in nephron sparing surgery (NSS) comparing males vs females in
terms of epidemiological and clinical features in a multicentre Italian dataset (RECORd Project).
Overall, 1055 patients treated with nephron sparing surgery (NSS) between January 2009 and December
2012 were evaluated. A comparison of gender on pre-, intra- and post-operative variables was performed.
Results
Overall, 630 males and 346 females were analysed. No significant difference was found between males and
females in age (analysed as continuous and nominal (
Discussion
It seems that NSS in males presents a higher difficulty (higher EBL, intraoperative time and intraoperative
complication). A possible explication can be higher BMI and surgical indication, but this result should
be further confirmed by a matched pair comparison. Females present higher rate of benign tumours, as
described in literature. Males present a slightly higher clear cell RCC rate with higher Fuhrman grade.
Conclusions
To our knowledge this is the main Italian analysis regarding epidemiologic and clinical features in NSS
related to gender.
Discussione
nn
Conclusioni
This study demonstrated that in RCC the number of lymph nodes involved correlates with prognosis,
especially in patients with distant metastases. According to our data, the actual classification of nodal
involvement should be modified.
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LA CONSISTENZA (FRIABILE VS COMPATTA) E’ UN FATTORE PROGNOSTICO
INDIPENDENTE NEI PAZIENTI CON CARCINOMA RENALE NON METASTATICO CON
TROMBOSI VENOSA
PERIOPERATIVE AND ONCOLOGICAL OUTCOMES IN PATIENTS WITH RENAL CELL
CARCINOMA INVADING SUPRADIAPHRAGMATIC VENA CAVA AND TREATED WITH
NEPHRECTOMY AND CAVAL THROMBECTOMY WITH EXTRACORPOREAL CIRCULATION
AND DEEP HYPOTHERMIC CIRCULATORY ARREST
A. Antonelli, M. Yarygina, G. Galvagni, M. Furlan, M. Sodano, T. Zanotelli, R. Tardanico, C. Simeone
(Brescia)
Scopo del lavoro
E’riportato da Bertini e coll. che la consistenza della trombosi tumorale sia un fattore prognostico in pazienti
con carcinoma renale e trombosi venosa. Ad oggi solo uno studio ha verificato tale ipotesi, ottenendo
parziale conferma. Scopo del lavoro è valutare in pazienti con lungo periodo di follow up quale sia il ruolo
prognostico della consistenza della trombosi.
Materiali e metodi
Dall’analisi del database istituzionale che raccoglie circa 2000 pazienti operati negli ultimi 30 anni,abbiamo
ricavato 147 pazienti con trombosi venosa e disponibilità dei preparati istologici. Rivisti i dati da due
uropatologi si è verificata la diagnosi e definito se la trombosi era compatta (C-Th; >90% di trombo
rappresentato da tessuto neoplastico compatto, coesivo, a profilo tondeggiante, regolare, talora con parziale
rivestimento endoteliale) o friabile (F-Th; >10% di trombo rappresentato da tessuto a profilo irregolare,
talora con frange pseudopapillari, frammentato, poco coesivo, con aree necrotiche, raccolte ematiche
o depositi fibrinici). E’stata valutata la correlazione statistica tra consistenza della trombosi ed alcuni
fattori prognostici noti ed è stata fatta un’analisi della sopravvivenza cancro-correlata applicando in uni- e
multivariata un modello di regressione logistica di Cox.
Risultati
Dalla revisione anatomo-patologica emerge che 67 pazienti (45.6%) presentavano una F-Th, 80 (54.4%)
una C-Th. I pazienti sono stati seguiti per un periodo mediano di follow up di 41 mesi (IQR 14-78 mesi).
All’analisi univariata mostrano correlazione significativa con la sopravvivenza cancro-correlata diametro
tumorale, invasione dei tessuti perirenali, presenza di metastasi a distanza, grading 4, necrosi, invasione
microvascolare e presenza di una F-Th. All‘analisi multivariata, mantiene la correlazione solo la presenza di
metastasi a distanza (RR 3.406, 95% CI 1.892-6.132, p
Discussione
La presenza di una F-Th si associa in modo statisticamente significativo ad un livello craniale più alto
raggiunto dalla trombosi, alla presenza di metastasi linfonodali ed a distanza,di invasione microvascolare, ad
un grading elevato e alla necrosi.
R. Bertini, U. Capitanio, R. Colombo, M. Freschi, D. Di Trapani, G. La Croce, C. Carenzi, V. Di Girolamo,
G. Zanni, P. Rigatti, F. Montorsi (Milano)
Scopo del lavoro
In locally advanced renal cell carcinoma (RCC) cases, tumor thrombus (TT) may grow cephalad up to
the level of the right atrium. The mainstay of surgical treatment for such lesions remains resection of all
possible tumor burden. We aimed to report peri-operative complication rates and oncological follow-up in
a large series of patients with RCC invading supradiaphragmatic vena cava and treated with nephrectomy
and caval thrombectomy with extracorporeal circulation and deep hypothermic circulatory arrest (NT+CT in
EC+HCA).
Materiali e metodi
Among 1983 RCC patients treated with nephrectomy at single academic institution, 40 consecutive patients
presenting with RCC and a supradiaphragmatic TT underwent NT+CT in EC+HCA between 1990 and
2012. Descriptive analyses, Kaplan-Meier method and Cox regression analyses were used to report the
perioperative and long term follow up of those patients.
Risultati
Mean age resulted 59.1 yrs (range 35-74). At diagnosis, patients reported no vs. regional vs. systemic
symptoms in 20% vs. 47% vs. 33% cases, respectively. American Society of Anesthesiologists (ASA) score
resulted 1, 2, 3 and 4 in 28%, 18%, 49% and 5%, respectively (p<0.001).
Discussione
Although affected by bulking RCC invading supradiaphragmatic vena cava and treated with major
cardio and urological surgery, patients treated with NT+CT in EC+HCA have acceptable perioperative
complication rates.
Conclusioni
A non-negligible overall and cancer specific survival should be expected for patients with renal cell
carcinoma invading supradiaphragmatic vena cava without distant metastases at diagnosis and treated with
NT+CT in EC+HCA.
Conclusioni
Le caratteristiche anatomo-patologiche dei pazienti con F-Th sono significativamente peggiori di quelle con
C-Th. La presenza di F-Th è un fattore prognostico negativo indipendente, solo nei casi senza metastasi a
distanza. Pertanto la consistenza della trombosi dovrebbe essere abitualmente segnalata dal patologo.
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PREDICTIVE VALUE OF INTRAOPERATIVE ENLARGED LYMPH NODES DURING RADICAL
NEPHRECYTOMY
THE PROGNOSTIC IMPACT OF TUMOR SIZE ON CANCER-SPECIFIC AND OVERALL
SURVIVAL AMONG PATIENTS WITH PATHOLOGIC T3A RENAL CELL CARCINOMA.
P. De Angelis, F. Regis, G. Bondonno, M. Fusano, A. Di Domenico, A. Volpe, L. Zegna, B. Cavallone, F.
Sogni, C. Terrone (Novara)
M. Borghesi, E. Brunocilla, F. Chessa, H. Dababneh, C. Pultrone, V. Vagnoni, G. Gentile, L. Bianchi, D.
Romagnoli, B. Longhi, S. Rizzi, F. Manferrari, G. Martorana, R. Schiavina (Bologna)
Aim of the study
to evaluate if the macroscopic aspect of lymph nodes (enlarged or not) during radical nephrectomy (RN) for
renal cell carcinoma (RCC) is a predictive factor for nodal involvement.
Aim of the study
Surgical excision remains the mainstay of treatment in all cases of non-metastatic renal cell carcinoma
(RCC), even in non-organ confined tumors, and survival rates are strongly influenced by several
clinicopathological features, such as tumor size, pathological stage, nuclear grade, histological tumor
necrosis, and the presence of sarcomatoid features. T3a RCC are being classified only according to their
anatomic extension (perirenal/sinus fat invasion or renal vein involvement), regardless of tumor size;
consequently, small and large neoplasms are still classified together. The aim of the present study is to
determine whether the tumor size could be an important prognostic parameter in patients with pathological
T3a RCC, and to identify the optimal threshold for cancer-specific and overall mortality rates in a defined
cohort of patients treated with radical nephrectomy for locally advanced renal cell carcinoma.
we reviewed the operative and the pathology reports of all consecutive patients submitted to RN for RCC
at 3 Urologic centers (Molinette University Hospital –Torino; S. Luigi University Hospital – Orbassano;
Maggiore della Carità University Hospital, Novara), from November 1983 to September 1999, from October
1988 to December 1999 and from February 2000 to October 2012, respectively. The following variables
reported in a specific data base were evaluated: pathological stage, number of lymph nodes removed,
macroscopic aspect of lymph nodes. Predictive value, sensitivity, specificity of macroscopic enlargement of
regional lymph nodes were evaluated.
Results
the number of patients submitted to RN was 930. Lymphadectomy was performed in in 697 patients. The
macroscopic aspect of regional lymph nodes was described in the operative reports in 542 cases (78%). The
mean age of these patients was 59.7 years (range 21-88). The average number of lymph nodes removed was
9.4 (range 1-43). Lymph node metastases were demonstrated in 50 patients (9.2%), whereas in the remaining
cases most of the disease-free lymph nodes had reactive hyperplasia. Macroscopic enlarged lymph
nodes were reported in 159 patients: 44 (28%) had lymph node involvement at histological examination.
In 383 patients no enlarged lymph nodes were identified: 6 N+ were histologically demonstrated. The
accuracy, sensitivity and specificity of macroscopic aspect of lymph nodes were 77.6%, 88.0% and 76.6%
respectively.
Discussion
the clinical detection of lymph node involvement depends on an increase in number or size of the nodes.
At present there is no imaging method that can confidently be used to differentiate between metastases and
hyperplastic nodes. In 1990, Studer et al. found 42% histologically positive nodes in patients with enlarged
nodes at preoperative CT, while the incidence of false negative results was 4.1%. Our study was not based
on preoperative imaging but on the macroscopic aspect of lymph nodes during radical nephrectomy.
According to Studer et al, enlarged lymph nodes are frequently hyperplastic without metastatic involvement.
Therefore, in these cases an accurate lymph node dissection is the only mean providing knowledge of the
real status of regional lymph nodes.
We analyzed our database of patients who underwent radical nephrectomy for RCC between July 2000 and
December 2013. Clinical and pathological data were undertaken for each patient. T3a subjects were divided
into two subgroups according to the most informative threshold for pathological tumor dimension able to
predict survival outcomes (Group 1: ≤ 8 cm, Group 2: > 8 cm). Differences were considered statistically
significant with a P value < 0.05.
Results
Globally, 185 consecutive patients were evaluated. The median (IQR) follow-up was 32 (18-62) months.
The median (IQR) pathologic tumor size was 7.5 (5.7-10) cm. Seventy (34.3%) patients died of RCC during
the follow-up period. Group 2 patients experienced worse cancer specific survival (CSS) rates compared to
Group 1, (5- and 10- year CSS: 52% and 40% vs. 67% and 63%, respectively, p=0.001). Overall survival
(OS) rates were significantly lower for patients included into Group 2 compared to the other one (5- and 10year OS rates: 46% and 38% vs. 60% and 57%, respectively, p=0.01). Subgroups stratification (HR: 3.65, p
Discussion
.
Conclusions
Tumor size demonstrated to be an independent prognostic factor in pT3a RCC, with worse oncological
outcomes observed in those patients with a tumor dimension > 8cm. The current TNM classification of the
pT3a stage still not precisely correlate with CSS outcomes, and tumor size should be taken into account in a
future revision of the TNM staging system.
Conclusions
with the limit of this retrospective study, our data indicate that most of the patients with RCC and
macroscopically enlarged lymph nodes has no metastatic disease. The absence of macroscopically enlarged
lymph nodes has an high predictive value for a pN0 stage.
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“TRAPIANTO DI RENE DA DONATORE VIVENTE: CASISTICA IN SINGOLO CENTRO”
A TWO-INSTITUTIONAL EXPERIENCE WITH ROBOTIC SINGLE-SITE PYELOPLASTY:
SURGICAL AND FUNCTIONAL OUTCOMES
R. Tarabuzzi, G. Bondonno, A. Volpe, G. Ceratti, G. Marchioro, M. Favro, F. Sogni, C. Terrone (Novara)
Scopo del lavoro
Presentiamo i risultati dell’attività di trapianto di rene da donatore vivente dal gennaio 2003 al febbraio 2014
presso il nostro Centro Trapianti
Materiali e metodi
I candidati alla donazione ed i riceventi sono stati selezionati sulla base delle linee guida italiane e della
legislazione corrente. Sono stati raccolti in un database in modo prospettico i parametri preoperatori e
postoperatori e funzionali del donatore vivente e del ricevente. Il follow-up è stato eseguito presso il
nostro Centro Trapianti. Il donatore è stato sottoposto a controlli ogni 3 mesi nel primo anno, ogni 6 mesi
nel secondo anno e successivamente a controllo annuale. Il ricevente invece è stato sottoposto a controlli
settimanali nel 1°mese, bisettimanali nel 2° mese, mensili dal 3° mese, semestrali dal 1° anno e annuali dal
5° anno in poi
Risultati
Presso il nostro Centro Trapianti, dal 1998 ad aprile 2014 sono stati eseguiti 1000 trapianti renali. Nel
2003 è iniziata l’attività di trapianto di rene da vivente e nel 2006 è stato eseguito il primo prelievo con
tecnica laparoscopica. Ad Aprile 2014 sono stati effettuati 43 trapianti da donatore vivente, di cui 7 open
e 36 laparoscopici. L’età mediana dei donatori è di 54 anni (IQR 49-60). Il donatore ed il ricevente erano
consanguinei nel 74% dei casi (99% coniugi). La creatinina mediana preoperatoria dei donatori era di
0,8 mg/dl (IQR 0,7-0,9). Il rene prescelto per la donazione è stato in tutti i casi il sinistro. In 8/43 casi era
presente una doppia arteria renale. La durata mediana dell’intervento è stata di 195 minuti (IQR 180-237) e
quella dell’ischemia calda è stata di 155 secondi (IQR 110-180). Nel post-operatorio 13/43 pazienti hanno
ricevuto emotrasfusioni con emazie autologhe. Due riceventi hanno avuto una stenosi dell’anastomosi
ureterale, che è stata corretta chirurgicamente. Un ricevente ha sviluppato un adenocarcinoma vescicale.
La creatinina post-operatoria mediana dei donatori e dei riceventi è stata rispettivamente di 1,1 mg/dl (IQR
1-1,4) e di 1,5 (IQR 1,2-1,8). All’ultimo follow-up la creatinina mediana dei donatori e dei riceventi è stata
rispettivamente di 1,2 mg/dl (IQR 1-1,3) e d. 1,4 mg/dl (IQR1,1-1,8), con un follow-up mediano di 39 mesi
(IQR 19-59). Un solo ricevente risulta deceduto ma non per complicanze del trapianto
Discussione
In Italia vi sono più di 6 mila pazienti in lista di attesa per trapianto da cadavere. Circa l’1% di questi
pazienti muore in attesa di trapianto. La dialisi non è priva di complicanze e non consente una qualità di
vita ottimale. Nei soggetti idonei, il trapianto di rene da donatore vivente rappresenta un’ottima opzione per
ristabilire una funzione renale normale e migliorare la qualità di vita dei pazienti con IRC terminale, senza
pregiudicare la salute dei donatori
Conclusioni
Il prelievo di rene da donatore vivente a scopo di trapianto può essere eseguito in modo sicuro mediante
laparoscopia, con i vantaggi della mini-invasività. La curva di apprendimento risulta rapida se eseguito in un
centro con adeguata esperienza
94
G. Lista, N. Buffi, G. Lughezzani, N. Fossati, M. Lazzeri, G. Guazzoni, A. Abrate, C. Fiori, A. Larcher, A.
Cestari, F. Porpiglia (Milano)
Scopo del lavoro
Laparoscopic single site pyeloplasty has been recently introduced with the intent to reduce the invasiveness
of traditional laparoscopic pyeloplasty. However this procedure is technically challenging and needs
high laparoscopic surgery skills. The introduction of robotic single site pyeloplasty technique aims to
overcome these technical difficulties. The aim of this study was to report the outcomes of robotic single site
pyeloplasty within two high volume laparoscopic and robotic surgery centers.
Materiali e metodi
We retrieved data from 30 patients treated with robotic single site pyeloplasty for ureteropelvic junction
obstruction in two centers (namely San Luigi Hospital, Orbassano, Italy and San Raffaele Turro Hospital,
Milano, Italy) between July 2011 and January 2013. Patients were selected according to the results of
imaging techniques and the presence of symptoms (recurrent flank pain, recurrent urinary tract infections
etc.) Robotic single site pyeloplasty was performed using the new da Vinci single-site robotic surgery
platform according to the Anderson Hynes technique. Perioperative and post-operative outcomes were
reported. Data were collected in a prospective fashion using questionnaires (POSAS scale) to objectively
assess aesthetic results. Intraoperative and postoperative complications were reported according to the
Clavien Dindo classification and postoperative pain was evaluated using the VAS scale. Follow-up included
CT urography, MAG-3 diuretic renal scan and urine analysis at 3 months and 1 year after surgery, as well as
clinical evaluation of symptoms relief.
Risultati
Median patient age was 37 (19-65) and median BMI was 23 (19-29). Median operative time was 165 min
(101-300). Median postoperative stay was 5 days and median catheter removal was 3 days (2-7). Only
two cases required conversion to either standard laparoscopic technique or to standard robotic technique.
No intraoperative complications were reported. Postoperative complications rate was 26% (n: 8). Most
of them were grade 1 (13%) followed by grade 2 (10%) and 3 (3.3%) complications according to Clavien
classification. Twenty-three patients (76%) had a resolution of symptoms after the operation and 21 patients
(70%) had a resolution of hydronephrosis. The overall success rate was 96.6 % at a mean follow up of
11 months. Most of the patients had no pain at the dismissal (80% had 0 or 1 according to the VAS scale)
and 87% of the patients had no pain at 3 months (0 or 1 according to the VAS scale). Median patient scar
assessment scale (PSAS) score was 3 (range 0-7).
Discussione
R-LESS pyeloplasty is a challenging technique due to either still inadequate instruments and the lack of
adequate bed side assistance. Further study with longer follow up are needed to assess the long term efficacy
of this new surgical technique.
Conclusioni
Single site robotic pyeloplasty is a feasible technique in selected patients, with fast recover and good
aesthetic results .
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ACCESSO LAPAROSCOPICO: ANALISI DI DATI MULTICENTRICI RIGUARDANTI PIU’ DI
65.000 PROCEDURE
NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY (NOTES): ESPERIMENTO
IN VIVO PER UNA NUOVA CHIUSURA ENDOSCOPICA RIASSORBIBILE DELL’ACCESSO
VESCICALE.
E. Martorana, A. Ghaith, M. Rani, M. Rosa, S. Micali, G. Bianchi (Modena)
Scopo del lavoro
Analizzare le tecniche utilizzate in urologia per realizzare l’accesso laparoscopico, valutare le relative
complicanze e identificare il tipo di accesso teoricamente più sicuro.
Materiali e metodi
Abbiamo condotto una overview inviando un questionario a 80 noti urologi laparoscopisti tra il Giugno e
il Dicembre 2013. Il questionario era articolato in 12 domande divise in 2 parti: la prima parte indagava il
numero di procedure eseguite e il tipo di accesso utilizzato; la seconda parte del questionario quantificava le
complicanze intra e post-operatorie e indagava il tipo di gestione adottata.
Risultati
La response rate è stata del 51, 25 % per un totale di 65.636 procedure (56.236 transperitoneali e 9.400
retroperitoneali). Due questionari sono stati esclusi per incompletezza dei dati. L’accesso trans-peritoneale
più utilizzato è stato il blind trocar (38,5% dei chirurghi) seguito dall’accesso open (33,3% dei chirurghi)
e dall’accesso con trocar ottico (17,9% dei chirurghi). Il 10.3% dei chirurghi ha dichiarato di utilizzare più
di un tipo di accesso. Il 61% dei chirurghi utilizza l’ago di Veress per creare lo pneumoperitoneo. Il 76,9%
dei chirurghi esegue anche accessi retroperitoneali: il 90% di questi esegue l’accesso con tecnica open e il
10% con l’ausilio del trocar ottico. Il 79.5% e l’89,7% dei chirurghi ha riportato complicanze intra- e postoperatorie rispettivamente. La complicatio rate intra-operatoria è stata del 3,3% quella post operatoria del
9,6%. La tabella 1 riassume e quantifica le complicanze pre- e postoperatorie in relazione al tipo di accesso
utilizzato. Gran parte delle complicanze ha avuto gestione conservativa o laparoscopica. La conversion rate
è stata dell’ 0.33% (53,8 % dei chirurghi), la trasfusion rate è stata del’1.13% (56.4% dei chirurghi) e il tasso
di re-intervento perioperatorio è stato dello 0,3%.
Discussione
Il nostro studio ha mostrato che l’accesso trans-peritoneale è più diffuso in USA che in Europa e che,
al contrario, l’accesso retroperitoneale è più utilizzato in Europa. Sfortunatamente non esistono dati in
letteratura per confrontare questi risultati. Nel nostro studio non sono state riportate motivazioni specifiche
per la scelta di un tipo di accesso rispetto a un altro. Tale scelta potrebbe essere in relazione con l’esperienza
del chirurgo e/o le caratteristiche del paziente. I nostri dati hanno però dimostrato che la scelta del tipo di
accesso potrebbe riflettersi sul tipo e sulla quantità di complicanze intra e post-operatorie.
A. Cicione, F. Cantiello, C. Oliveira, G. Ucciero, R. Autorino, M. De Sio, E. Lima, R. Damiano (Germaneto)
Scopo del lavoro
Valutare efficacia e sicurezza di una suturatrice endoscopica per la chiusura della perforazione vescicale
durante chirurgia NOTES.
Materiali e metodi
in otto maiali anestetizzati è stata eseguita endoscopicamente una cistotomia lunga 10mm (quattro maiali) o
20mm (quattro maiali). Successivamente una suturatrice endoscopica (RD 180®, LSI solutions®) introdotta
attraverso il canale operativo di un cistoscopio 30 Fr è stata utilizzata per suturare con filo riassorbibile
(Poliglactyn) le otto incisioni vescicali. La sutura è stata valutata immediatamente distendendo sotto
controllo laparoscopico la vescica con soluzione salina mista a 3% di blu di metilene. Successivamente,
dopo tre settimane, un esame necroscopico è stato eseguito per valutare lo stato di cicatrizzazione della
sutura e ricercare eventuali segni di infiammazione peritoneale.
Risultati
tutte le otto cistotomie sono state saturate con un tempo medio di 10±4.3 minuti. Al termine dell’esperimento
non si è osservata dispersione di blu di metilene dalla sutura. Durante le tre settimane, i maiali si sono
nutriti normalmente. Infine, l’esame necroscopio ha evidenziato una completa cicatrizzazione della lesione
vescicale in assenza di segni di peritonite.
Discussione
la NOTES è stata introdotta come una possibile chirurgia scarless, tuttavia la necessità di ulteriori
perfezionamenti tecnologici la rendono ancora un approccio di tipo sperimentale. Il presente studio
descrive un nuovo metodo adoperante suture completamente riassorbibili che riducono il rischio litogenico
precedentemente descritto con metodi diversi. Sebbene alcune limitazioni dello studio esistono (natura
sperimentale, necessità di un cistoscopio 30Fr), tale metodo potrebbe essere impiegato anche nella gestione
delle perforazioni vescicali iatrogene.
Conclusioni
la suturatrice endoscopica utilizzata, già commercialmente disponibile, ha rappresentato un valido strumento
per eseguire una sutura riassorbibile della perforazione vescicale. Ulteriori test sono ancora necessari prima
della sua applicazione clinica nella gestione delle perforazioni vescicali.
Conclusioni
L’accesso laparoscopico è un approccio sicuro. Gran parte delle complicanze possono essere gestite
laparoscopicamente e non richiedono la conversione a cielo aperto. Non sono state trovate conclusioni
definitive riguardo la scelta del tipo di accesso ma le complicanze relative all’accesso laparoscopico
sembrano dipendere dalla scelta del tipo di accesso più sicuro. In accordo con i nostri dati l’accesso più
sicuro è quello con trocar ottico.
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PROSTATECTOMIA RADICALE RETRO PUBICA PER CARCINOMA PROSTATICO NEI
PAZIENTI TRAPIANTATI RENALI
SINGLE SITE DAVINCI DISMEMBERED PYELOPLASTY: NOSTRA ESPERIENZA
S. Caroassai, D. Villari, T. Jaeger, M. Marzocco, A. Delle Rose, V. Limarzi, S. Serni, N. Stomaci, M.
Zanazzi, G. Nicita (Florence)
Scopo del lavoro
I dati della letteratura non offrono certezze terapeutiche sul trattamento del carcinoma prostatico nel
trapiantato renale non avendo ancora individuato il gold standard terapeutico per questa neoplasia. La
prostatectomia radicale nel paziente trapiantato presenta difficoltà tecniche legate alla presenza del graft
e alla terapia immunosoppressiva che determina un rischio maggiore di sviluppare complicanze post
chirurgiche. Scopo del lavoro è valutare la fattibilità e la sicurezza della prostatectomia radicale retro pubica
nei pazienti trapiantati renali, valutandone l’outcome oncologico e funzionale.
Materiali e metodi
Abbiamo sottoposto a prostatectomia radicale retro pubica 12 pazienti trapiantati renali affetti da
Carcinoma prostatico diagnosticato mediante ago biopsia prostatica eseguita per sospetto clinico di Pca. La
prostatectomia è stata sempre eseguita da un chirurgo con esperienza nel trapianto di rene. Tutti i pazienti
al momento della diagnosi di PCa presentavano graft funzionante. L’età media è risultata pari a 62,1 anni
(range 50-70),il PSA medio alla diagnosi è stato pari a 8,2(range 5,3-12,5). Il gleason bioptico è stato il
seguente: in 6 casi 3+3, in un caso 3+4,poi in uno 4+3,in uno 3+5, in uno 2+3 infine in un caso è stato
segnalato un basso grado di differenziazione.
Risultati
Nei 12 pazienti sottoposti a prostatectomia radicale con follow up medio di 55.3 mesi(range 16-179) non
sono state registrate complicanze maggiori,ne danni iatrogeni al rene trapiantato e all’uretere trapiantato.
2/12 pazienti hanno richiesto antibiotico terapia prolungata per febbre e 1/12 paziente è stato sottoposto
a emotrasfusione dopo l’intervento. In 1 paziente è stata eseguita radioterapia post operatoria associata a
terapia ormonale, in due pazienti si è verificata ripresa biochimica di malattia,una solo paziente ha presentato
ripresa clinica di malattia che ha portato a decesso. Durante il follow up abbiamo registrato tre decessi,uno
cancro specifico,due per cause non correlate. Un solo paziente sottoposto a prostatectomia è tornato alla
terapia dialitica per nefropatia da rigetto cronico già in essere al momento della chirurgia. E’stato possibile
eseguire linfectomia iliaca otturatoria bilaterale in 2/12 pazienti mentre in 6/12 la linfectomia è stata eseguita
controlateralmente alla sede di trapianto.
Discussione
In corso di prostatectomia retro pubica nel trapiantato sono presenti alcune criticità che impongono al
chirurgo attenzione particolare e conoscenza della chirurgia trapiantologica:la linfectomia iliaco otturatoria
omolaterale al graft risulta estremante complicata e spesso infattibile, la preparazione del Retzius deve
essere eseguita con cautela per evitare danni iatrogeni all’uretere del graft,il posizionamento dei divaricatori
può essere causa di danno del rene trapiantato.
V. Giommoni, F. Annino, S. Khorrami, T. Verdacchi, M. De Angelis (Arezzo)
Scopo del lavoro
Presentiamo la nostra esperienza con il sistema Single Site daVinci per il trattamento della patologia del
giunto pieloureterale con unico accesso ombellicale.
Materiali e metodi
Il sistema prevede l’accesso singolo tramite l’ombelico con un’incisione di 2 cm circa. Il trocar permette
l’introduzione di 2 cannule robotiche da 5 mm curve 1 da 8 mm rettilinea per l’ottica, una da 5 o 10 mm per
l’aiuto. Gli strumenti robotici si incrociano all’interno del trocar. Il software robotico riassegna gli strumenti
in modo intuitivo eliminando l’incrocio, in modo che l’operatore guida con la mano destra lo strumento
che nel campo operatorio si trova a destra ma è posto sul braccio robotico di sinistra. In 7 di 8 interventi
sono stati utilizzati i seguenti strumenti: uncino monopolare, forbici fredde, mariland fredda, portaghi.
In un intervento si è utilizzata la Maryland Bipolare e non si è utilizzato l’uncino. La sutura utilizzata è
stata Monocryl 4/0 ago visiblack 17mm. La tecnica utilizzata è stata l’Anderson Hynes. Il doppio J è stato
posizionato per via retrograda su guida sensor posizionata preventivamente per via endoscopica. Abbiamo
eseguito il primo caso in Luglio 2012 e da allora abbiamo eseguito 8 casi (5 destra 3 sinistra). Tranne il
primo caso, selezionato per BMI, gli altri casi sono stati eseguiti progressivamente in tutti i pazienti con
stenosi del giunto pieloureterale senza distinzione di BMI o pregressa chirurgia. Il BMI medio è stato di 24,8
(range 19,8-31) . Un paziente era già stato operato di colecistectomia laparoscopica. L’età media era pari a
30 anni (range 22-45). Sei uomini e due donne.
Risultati
Tutti gli interventi sono stati completati con tecnica single site dal medesimo operatore con esperienza
robotica e laparoscopica. Il tempo chirurgico medio è stato: Consolle 105 min (R: 68-132); Docking 13 min
(R: 6-37); Posizionamento Singleport e accesso 24,5 min (R: 14-41); Totale 171 min (R: 118-211). Non si
sono osservate complicanze intraoperatorie. Nel postoperatorio 1 paziente ha sviluppato un’urinoma in 5
gg PO in conseguenza di ostruzione del doppio J ed è stata sottoposta a sostituzione dello stent ureterale e
drenaggio percutaneo della raccolta. Tutti i pazienti sono stati dimessi in 3 gg PO tranne uno dimesso in 5 gg
PO per iperpiressia. Con follow-up medio e 7 mesi (R: 0-18) nessun paziente ha mostrato recidiva di stenosi.
Discussione
Per quanto ancora discutibile l’utilità dell’accesso single site in rapporto ai risultati comparabili della
metodica multiport, riteniamo che tale strumento sia un passaggio obbligato verso una chirurgia sempre
meno invasiva che va oltre un discorso puramente estetico.
Conclusioni
La Single Site daVinci Pyeloplasty è una metodica fattibile con risultati potenzialmente comparabili alla
chirurgia robot assistita multiport. Permette di semplificare molto la chirurgia LESS seppur la strimentazione
sia ancora limitata. Le potenzialità del sistema sono promettenti per un possibile ampliamento di indicazioni.
Conclusioni
La prostatectomia radicale retro pubica nel paziente trapiantato renale è risultata sicura e fattibile mostrando
risultati soddisfacenti sia in termini di outcome oncologico che funzionale del graft.
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TRATTAMENTO DELLE STENOSI URETERALI DOPO TRAPIANTO RENALE. ANALISI DEI
RISULTATI
TRATTAMENTO LAPAROSCOPICO E ROBOTICO DELLE STENOSI URETERALI (S.U.), DI
UNO STUDIO MULTICENTRICO A TRE ANNI DI FOLLOW UP.
E. Dalmasso, A. Bosio, F. Lasaponara, O. Sedigh, G. Pasquale, B. Lillaz, E. Alessandria, P. Gontero, B. Frea
(Torino)
S. Zaramella, A. Minervini, A. Cocchi, R. Fantechi, D. Dente, P. Parma, A. Antonelli, M. Falsaperla, A.
Celia, B. Rocco, V. Pagliarulo, A. Porreca (Novara)
Scopo del lavoro
Obiettivo dello studio è stato di valutare i risultati a lungo termine dei diversi tipi di trattamento delle stenosi
ureterali nel trapianto renale (TX)
Scopo del lavoro
la chirurgia laparoscopica e robotica presenta indubbi vantaggi in termini di mini invasività, in ambito
urologico rappresentano il trattamento di scelta di molte patologie neoplastiche, funzionali e malformative;
scopo dello studio è valutare la morbilità e l’efficacia di queste tecniche nella correzione delle stenosi
ureterali (S.U.) di varia eziologia
Materiali e metodi
Analisi retrospettiva su 42 casi di stenosi ureterali in trapianti renali trattate tra il 1999 e il 2010. I parametri
per definire il successo del trattamento sono stati il recupero della funzione del graft e la non necessità di
stent ureterale o pielostomia ad almeno 1 anno. Per l’analisi statistica è stato utilizzato il test di Fisher
Risultati
Tempo di insorgenza: entro 90 giorni dal TX nel 45% dei casi (precoce), dopo 90 giorni nel 55% (tardiva).
Pielografia anterograda: stenosi severa nel 55% dei casi, moderata nel 38%, lieve nel 7%. Il trattamento
percutaneo è stato tentato 32 volte (76% dei casi): dilatazione con palloncino e posizionamento di stent
ureterale ≥ 7 F (91% dei casi), unicamente posizionamento di stent nelle stenosi lievi (9% dei casi).
25 pazienti (60% dei casi) sono stati sottoposti ad intervento chirurgico: 10 in prima battuta e 15 dopo
fallimento della dilatazione percutanea con palloncino. Sono stati eseguiti 14 reimpianti ureterali (RU), 9
ricostruzioni con via escretrice nativa [4 uretero-uretero anastomosi (UU) e 5 pielo-ureteroanastomosi (PU)]
e 2 lisi di fibrosi periureterale. Il successo complessivo a lungo termine del trattamento percutaneo è stato
del 34%. Il posizionamento di stent ureterale, eseguito nelle stenosi lievi, ha avuto successo in tutti i casi;
la dilatazione singola con palloncino nel 30% dei casi, la dilatazione ripetuta nel 16%. Il tasso di successo è
stato significativamente maggiore (p = 0.001) in caso di stenosi distale rispetto alle altre sedi (73% vs 14%).
Nessuna differenza significativa è stata evidenziata confrontando i tassi di successo nelle insorgenze tardive
e precoci (40% vs 29%, p = 0.71). Il successo a lungo termine del trattamento chirurgico è stato del 76%:
93% per il RU, 56% per la ricostruzione con via escretrice nativa (80% per la PU e 25% per la UU), 50%
per la lisi di fibrosi periureterale. Il tasso di successo del RU e della PU è stato significativamente superiore
rispetto alla UU (p = 0.04). Il successo complessivo della chirurgia è stato significativamente maggiore
rispetto al trattamento percutaneo (p = 0.004), ancor più se si considerano le stenosi severe e moderate (p <
0.001). Nessun graft è stato perso.
Discussione
Il posizionamento di stent ureterale si è dimostrato efficace nelle stenosi lievi e la dilatazione con palloncino
nelle stenosi distali. La chirurgia si è dimostrata superiore al trattamento percutaneo, soprattutto nelle stenosi
moderate e severe. Il RU e la PU hanno garantito un tasso di successo maggiore rispetto alla UU, gravata da
un elevato rischio di recidiva
Conclusioni
Il trattamento percutaneo è efficace nelle stenosi lievi e in quelle a sede distale. La chirurgia garantisce i
tassi di successo più elevati, soprattutto nelle stenosi moderate e severe. Il RU e la PU dovrebbero essere
considerati gli interventi di scelta
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Materiali e metodi
sono stati raccolti retrospettivamente i dati di pazienti affetti da S.U. trattate per via laparoscopica o robotassistita in 9 centri urologici italiani. Le variabili analizzate sono state: età dei pazienti, sede ed eziologia
delle stenosi, tempo operatorio e di permanenza dello stent, le complicanze secondo classificazione di
Clavien, e l’efficacia nel trattamento ad un follow up minimo di 12 mesi.
Risultati
tra Gennaio 2008 e Marzo 2014 57 pazienti sono stati operati [(età media 47,8 anni (range 17-74)], tipo
e sede della S.U. è riportata in tabella 1, la lunghezza media delle stenosi era di 2,3 cm (range 0,5-5). In
26 pazienti è stata eseguita una resezione ureterale segmentaria con anastomosi termino-terminale, in 27
un’ureterocistoneostomia ed in 4 un’ureterolisi. Tutti gli interventi sono stati eseguiti con approccio transperitoneale (41 per via laparoscopica, 16 per via laparoscopica Robot-assistita). Non sono state registrate
conversioni a chirurgia open, il tempo operatorio medio è stato di 203 minuti (range 55-720), in tutti i
pazienti è stato posizionato uno stent ureterale doppio J. Il tasso di trasfusione è stato del 3,5% [(2/57
pazienti) Clavien gr. 2], in un caso si è verificata una lesione della vena cava (Clavien gr. 2), un solo caso di
fistola ureterale è stata trattata con nefrostomia percutanea (Clavien gr. 3a). La degenza media è stata di 6,8
gg (range 4-16), il tempo medio di permanenza dello stent 33,3 gg (range 3-90). 38 dei 57 pazienti hanno
raggiunto almeno 12 mesi di follow up, e sono quindi valutabili, con un follow up medio di 34,7 mesi 36
pazienti (94,8%) sono liberi da stenosi mentre in 2 pazienti (5,2%) si è verificata una recidiva. In un caso la
recidiva è stata trattata con dilatazione endoscopica con palloncino, nel secondo caso con nefroureterectomia
per recidiva neoplastica.
Discussione
la chirurgia laparoscopica e robotica delle S.U. rappresenta spesso un intervento complesso di chirurgia
ricostruttiva, in mani esperte presenta basso rischio di conversione, le complicanze nella nostra serie sono
state accettabili, il tasso di re-intervento e di recidiva è basso
Conclusioni
con i limiti di uno studio retrospettivo i nostri dati dimostrano che la laparoscopica e la robotica sono
un trattamento promettente delle S.U. sia in termini di complicanze che di efficacia ad un follow up a
medio termine. Idealmente sarebbe auspicabile un prolungamento del follow-up e il disegno di uno studio
prospettico di confronto tra le metodiche
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UTILIZZO DELLA RISONANZA MAGNETICA SENZA MEZZO DI CONTRASTO NELLA
DIAGNOSTICA DELLE COMPLICANZE UROLOGICHE IN PAZIENTI SOTTOPOSTI A
TRAPIANTO RENALE
VALORE PREDITTIVO NELLA SOPRAVVIVENZA DEL GRAFT DELL’INDICE DI
RESISTENZA INTRARENALE
M. Fusano, A. Volpe, A. Stecco, P. De Angelis, F. Regis, G. Ceratti, F. Sogni, A. Airoldi, E. Radin, P. Stratta,
C. Terrone (Novara)
S. Forte, C. Miacola, F. Giangrande, V. Ricapito, F. Selvaggi, G. Lucarelli, S. Palazzo, M. Battaglia, P.
Ditonno (Bari)
Scopo del lavoro
Lo scopo di questo studio è quello di valutare l’utilità della risonanza magnetica senza mezzo di contrasto
(Uro-RM) nella diagnostica di complicanze urologiche in pazienti sottoposti a trapianto renale.
Scopo del lavoro
L’indice di resistenza intrarenale (IR) è un parametro calcolato per la valutazione dello status del graft
in corso di follow-up ecografico del rene trapiantato. A tutt’oggi non è ancora chiaro il valore predittivo
dell’IR, anche in funzione dell’epoca di esecuzione del test.
Materiali e metodi
Da settembre 2011 a febbraio 2014 i pazienti sottoposti a trapianto renale con sospetta complicanza
urologica (evidenziata sulla base del peggioramento degli indici di funzionalità renale e/o di dilatazione
della via urinaria del graft) sono stati sottoposti a Uro-RM. L’esame è stato eseguito con sequenze T1 e
T2 pesate sul piano assiale senza e con tecnica di soppressione del tessuto adiposo. I pazienti sono stati
successivamente sottoposti a correzione chirurgica o endoscopica delle complicanze urologiche.
Materiali e metodi
In questo studio monocentrico retrospettivo è stata valutata la correlazione tra l’IR e la sopravvivenza
dell’organo (SO) e del paziente dopo il trapianto. Sono stati valutati 268 pazienti trapiantati tra il 2003 e
il 2011 con un follow-up medio 73 mesi (12-136). L’IR è stato valutato a 8 giorni, a 6 mesi, a 1 anno e a 3
anni. Per calcolare il valore predittivo dell’ IR per la SO è stata utilizzata l’analisi ROC ed è stato identificato
come cut-off un valore di IR pari a 0,75.
Risultati
In 22 pazienti è stata evidenziata all’ecografia un’ectasia della via urinaria del rene trapiantato. La successiva
Uro-RM ha identificato le seguenti complicanze urologiche: 14/22 (64%) stenosi ureterali, 6/22 (27%)
raccolte perirenali (urinoma, linfocele, ematoma), 2/22 (9%) malrotazioni del rene trapiantato condizionanti
giuntopatia acquisita. La mediana del tempo di insorgenza è risultata essere 2 mesi (range 1-9). In 17/22 casi
(77%) la diagnosi posta dall’Uro-RM è stata confermata dal successivo iter daignostico. Nel restante 23%
dei casi le complicanze evidenziate all’Uro-RM non sono state confermate alla pielografia. Un totale di 28
procedure urologiche endoscopiche o chirurgiche sono stati eseguite in 21 pazienti: posizionamento di stent
ureterale (13/28), posizionamento di pielostomia (3/28), drenaggio di raccolta comprimente la via escretrice
(3/28), reimpianto ureterale (9/28). Un solo paziente non è stato trattato per risoluzione spontanea di raccolta
perirenale. È stato ottenuto un miglioramento dei valori di funzionalità renale dopo il trattamento nel 69%
dei casi (15/22), con una riduzione complessiva dei valori mediani di creatininemia da 2,6 mg/dL (range 1,34,9) a 1,9 mg/dL (range 1,1-4,2).
Risultati
Stratificando la popolazione a seconda dell’IR a 8 giorni (IR ≤0,75: 212 vs IR>0,75: 56) e a 6 mesi (IR
≤0,75: 237 vs IR>0,75: 31) si sono osservate differenze statisticamente significative tra i due gruppi a favore
di coloro che presentavano un IR ≤ 0,75 (p= 0,0078 a 8 giorni e p= 0,02 a 6 mesi) sulla SO. Al contrario si è
osservato che l’IR valutato a 1 anno e a 3 anni (IR ≤0,75: 229 vs IR>0,75: 39; IR ≤0,75: 224 vs IR>0,75: 44)
non è correlato con la SO.
Discussione
L’Uro-RM rappresenta un’indagine non invasiva, non nefrotossica e ben tollerata nei pazienti portatori di
trapianto con danno renale acuto, e si è dimostrata efficace nella maggior parte dei casi per caratterizzare la
complicanza urologica, definendo sede e causa di dilatazione e permettendo di scegliere il trattamento più
adeguato.
Discussione
Prendendo come cut off un lo stesso IR lo si è voluto correlare con la sopravvivenza del paziente dopo il
trapianto. Si è osservato che non sussistono correlazioni tra l’IR e la sopravvivenza assoluta.
Conclusioni
L’IR si è dimostrato un buon fattore di prognosi sulla sopravvivenza d’organo quando valutato nei primi
mesi di follow-up post trapianto. Tale parametro non sembra, invece, correlare con la sopravvivenza totale
del soggetto trapiantato.
Conclusioni
Alla luce dei risultati ottenuti da questo studio, l’utilizzo di Uro-RM risulta efficace e rappresenta un’utile
indagine per la diagnostica delle complicanze urologiche in pazienti sottoposti a trapianto renale.
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CLAMPLESS ROBOT-ASSISTED RENAL TUMORAL ENUCLEATION: INTRA AND
POSTOPERATIVE IMPLICATIONS OF CONTROLLED HYPOTENSION
CONVERSION FROM ROBOTIC TO OPEN SURGERY: TRANSLATING KNOWLEDGE FROM
MOTOR RACING TO HEALTHCARE
F. Scipioni, F. Lanzi, N. Tosi, F. Gentile, G. Pizzirusso, F. Cecconi, A. Canale, G. De Rubertis, G. Barbanti
(Siena)
F. Zattoni, A. Guttilla, A. Crestani, A. De Gobbi, F. Cattaneo, L. Angelini, A. Iannetti, C. Valotto, F. Dal
Moro, F. Zattoni (Padova)
Scopo del lavoro
The aim of this study is to evaluate the feasibility and safety of robotic-assisted renal tumoral enucleation
(RTE) with controlled hypotensive anesthesia to avoid hilar clamping and eliminate renal ischemia
Aim of the study
When complications occur during a robotic surgery, the consequences can often be minimized through
early recognition and appropriate intervention. In cases of emergency, the conversion from robotic to an
open surgery is not trivial and requires an adequate training of all the members of the team. The aim of our
work was to investigate the possible problems of a robotic conversion in cases of emergency, share a job
distribution flowchart and exercise doctors and nurses, as a team of Formula One, to perform as quickly as
possible a procedure which can save patient’s life.
Materiali e metodi
From April 2011 to January 2014 65 consecutive patients underwent robotic surgery for clinically localized
renal cancer. Overall 61/65 patients presented no major contraindications to hypotensive anesthesia; mean
age (range) was 64 (42-79) years. RTE is usually performed through a transperitoneal approach without
renal hylum isolation. In postoperative period patients were evaluated by daily physical examination and
routine blood tests on day 1 and 3. Additional examinations were performed in selected cases
Risultati
Mean arterial pressure during controlled hypotension was 66 mmHg (ranging between 62 and 95 mmHg)
and hypotension was prolonged meanly for 10.8 (range: 8,5-20,3) minutes. Mean (range) operative time
was 98.7 (71-182) minutes with mean blood loss of 150 ml (55-480 ml). No patients required intraoperative
blood transfusions. Mean (range) tumor size was 27 (10-68) mm and mean postoperative hospital stay was
3.1 (2-10) days. Overall 3 patients developed postoperative complications: 1 anemization treated by blood
transfusions and 2 delayed canalization that required nasogastric tube insertion. No patients developed major
medical complication (syncope, heart failure, stroke). In two cases we observed fatigue that regressed on
postoperative day 3. Mean (range) pre and postoperative serum creatinine was 1.0 (0.7-2.2) and 1.2 (0.7-2.7)
mg/dl respectively (p=0.487); mean estimated pre and postoperative glomerular filtration rate were 85.9 and
75.2 ml/minute/1.73m2. At histopathological evaluation it was found no positive surgical margins; in only 2
cases it was discovered a peritumoral pseudocapsule incision
Discussione
In literature it is widely demonstrated the need of minimizing ischemia during nephron sparing surgeryfor
renal tumors. Controlled hypotension may be an alternative to warm ischemia with renal hilar clamping or to
superselective clamping of arterial branches. Robotic assisted zero ischemia tumoral enucleation technique
is a reasonable approach to renal tumours irrespective to dimensions. Moreover, in our series, avoiding hilar
clamping did not increase the intra and postoperative complication rate and provided excellent functional
outcomes. The limit of this study is that available data are not adequately mature to determine long-term
functional outcomes and further experience and follow-up is mandatory
Conclusioni
Robotic assisted zero ischemia tumoral enucleation technique is a reasonable approach to renal tumours
irrespective to dimensions without increasing the intra and postoperative complication rate and providing
excellent functional outcomes
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By performing an analogue in proactive planning, active management and post hoc learning in the motor
racing pits stop we examined our robotic conversion to open surgery in case of emergency In the last 2
months we simulated several emergencies during a robotic surgery that required a conversion to open
surgery. An ordinary atmosphere of a robotic room was recreated. A human dummy was placed on the
operating table and a Da Vinci robot locked to it. All surgeons, anaesthesiologists, nurses and paramedical
staff were involved. Each type of professional was recognized through a different cap to be able to trace the
movements of each person during the conversion. All the simulations were timed and filmed. The videos at
the and were analysed in order to understand the problems and complications during the procedure.
Results
After several simulations our average conversion time was 93± 25 (57-183) seconds. At the and of our
training we reduced the conversion time by a mean of 45 seconds. In this simulations we found different
kind of problems. We tried to improve these in different ways(see table 1). We propose our flowchart for the
jobs distribution in the team (Table 2).
Discussion
We proposed a generic conversion model that can be applied to each robotic group. Though it is impossible
to to establish a universally accepted conversion model because each robotic group is composed of different
person with different habits and different ways of working. The geometry of the operating room is very
important and an accurate preliminary study for spaces is necessary.
Conclusions
The lessons from motor racing can be applied to healthcare for proactive planning, active management
and post hoc learning. Standardisation of working practices, interpersonal communication, consistency
and continuous development is fundamental for success. The application of these concepts would result in
improvements in the quality and safety in the conversion process from robotic surgery to open. We hope that
this study will be the beginning of courses and tests for each robotic team in order to improve, in cases of
emergency, in the conversion from robotic to open surgery.
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EARLY VS LATE UNCLAMPING IN LAPAROSCOPIC PARTIAL NEPHRECTOMY: EFFECT ON
RENAL FUNCTION AND EVALUATION OF THE INTRAOPERATIVE COMPLICATIONS.
LAPAROSCOPIC PARTIAL NEPHRECTOMY IN OBESE PATIENTS: EVALUATION OF THE
SURGICAL AND FUNCTIONAL OUTCOMES.
V. Altieri, F. Greco, S. Alba, P. Verze, P. Fornara, V. Mirone (Rocca di Neto)
F. Greco, S. Alba, V. Altieri, P. Verze, P. Fornara, V. Mirone (Rocca di Neto)
Scopo del lavoro
To evaluate the effect on renal function and evaluation of the intraoperative complications in patients
undergoing LPN for renal tumor with an early and late unclamping of the renal vessels.
Aim of the study
To evaluate the impact of body mass index (BMI) on surgical and functional outcomes of laparoscopic
partial nephrectomy (LPN) in patients affected by T1 renal tumors.
Materiali e metodi
This retrospective non-randomised study included 117 patients who underwent LPN with an early
unclamping (Group A) and 123 patients with a late unclamping of the renal vessels (Group B). All patients
were matched for age, sex, body mass index, tumor side (right or left kidney) and tumor characteristics
(R.E.N.A.L. nephrometry score). Demographic data, perioperative and postoperative parameters, including
operating time, estimated blood loss, complications, length of hospital stay, renal function, histological
tumor staging and grading, were collected and analysed. The postoperative function of the operated kidney
was evaluated by the measurement in different postoperative moments of serum creatinine and glomerular
filtration rate (GFR) so as by renal scintigraphy.
In this retrospective single-centre study, 240 consecutive patients underwent LPN for localised incidentally
discovered renal masses of < 7 cm (cT1). Patients were categorized into four groups according to their BMI,
as follows: group 1, normal weight (BMI < 25 kg/m2); group 2, overweight (BMI 25 – 29.9 kg/m2); group
3, obese (BMI 30 – 39.9 kg/m2); and group 4, morbidly obese (BMI ≥ 40 kg/m2). Demographic data, periand postoperative variables were collected and analysed.
Risultati
The mean operative time for Group A and Group B was 125.3±45.7 min and 132.1±35.4 min, respectively
(p= 0.07). Mean warm ischemia time was 11.2±3.5 min in the Group A and 19.5±8.2 min in the Group B
(p= 0.03). The mean complication rate was 4.3 % in the group A and 4.9% in the group B group (P = 0.12).
There were no grade 4 or 5 complications. Any conversion to radical nephrectomy was necessary. The mean
R.E.N.A.L nephrometry score for group A and B was 5.3±1.2 and 5.7±1.3 (p=0.21), respectively. Surgical
margins were positive in 4 patients (3.4%) of the Group A and in 2 patients (1.6%) of the Group B with renal
clear-cell carcinoma (p=0.03). At 1-vear-follow up all patients were recurrence-free. At the 4th postoperative
days GFR in both groups was 80.2± 1.6 mL/min/1.72m2 and 71.2±2.7 ml per min/1.72 m2, respectively
(p=0.08). At 1-year- follow-up the mean renal function, evaluated by a renal scintigraphy, was 48.05± 2.45%
in the Group A and 46.64± 3.86% in the Group B (p= 0.11), with a mean creatinine of 85.2±2.6 µmol/l in the
Group A and 86.1±1.2 µmol/l in the Group B (p=0.23); the mean GFR resulted to be 79.2±3.1 mL/min/1.72
m2 and 76.7±4.6 mL/min/1.72m2, respectively (p=0.07).
Discussione
Preserving a short duration warm-ischaemic time remains a challenging step during LPN. Early unclamping
technique, where only the initial parenchymal suturing is performed under ischaemia with the remainder of
bolstered renorrhaphy performed after unclamping, is associated with a reduction in the WIT by more than
50%.
Results
• The median operative time presented no statistically significant differences between BMI, whereas
estimated blood loss was higher in morbidly obese patients than in all other groups • Warm ischemia time
(WIT) and changes in eGFR were not influenced by the BMI groups and a decreased of the WIT was
reported for obese and morbidly obese patients when a early unclamping technique was used. • Increase in
BMI was not significantly associated with the occurrence of postoperative complications. In fact, the median
complication rate was 3.3% for normal BMI, 4.5 % for overweight patients, 4.8% for obese and 3.6% for
markedly obese patients • The definitive pathological results showed a high incidence for clear-cell tumors
in all groups. Surgical margins were positive only in 2 (1.8%) overweight patients and in 1 obese patient (2.3
%).
Discussion
LPN could be considered a viable treatment option for renal masses amenable to nephron-sparing surgery
also in patients with higher BMI.
Conclusions
A EUT should be always used in obese and morbidly obese individuals, considering the statistically
significant decrease of the WIT and the higher risk for chronic renal insufficiency in the elderly patients.
Conclusioni
Early unclamping during LPN reduces the warm ischemia time, improving the immediate postoperative
recover of the renal function.
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ZERO ISCHEMIA PARTIAL NEPHRECTOMY: our experience
Lucarelli G, Forte S., Campagna M, Colamonico O, Ricapito V, Palazzo S, Ditonno P, Battaglia M
Department of Emergency and Organ Transplantation - Urology, Andrology and Kidney Transplantation
Unit, University of Bari, Bari, Italy.
Mini-retroperitoneoscopic partial nephrectomy: feasibility, safety and
efficacy in a tertiary laparoscopic Centre
Background: Nephron-sparing surgery is thea standard treatment of small non-metastatic renal masses,
demonstrating comparable oncologic results and improved survival relative to radical nephrectomy. During
partial nephrectomy, transient hilar clamping is often used to maintain visualization during tumor excision
and renal reconstruction. Hilar clamping may lead to a decrease in renal function, which may be important
for patients with preexisting chronic kidney disease. Recent studies have demonstrated that every minute of
ischemia might be of relative importance. To ensure better renal function preservation, ongoing efforts have
focused on approaches allowing for minimized clamping or no clamping at all. We present the results of a
single center study of partial nephrectomy without hilar clamping and determine the risks and benefits of the
off-clamp approach in comparison with a clamped approach.
Materials and methods: Perioperative data of 131 patients who underwent to partial nephrectomy for renal
cell carcinoma (RCC) between January 2010 and December 2013 were retrospectively analyzed. All surgical
procedures were performed with the open approach. The renal artery was routinely localized and dissected
in case hilar clamping became necessary. After the Gerota fascia was opened, the tumor was identified and
demarcated. In 82 cases (62.6%) renal vessels were left unclamped, while a selective vascular dissection
technique was used. In the remaining 49 (37.4%) cases hilar clamping was performed. The perioperative
outcomes analyzed included age, gender, Charlson Comorbidity Index, body mass index (BMI), preoperative
tumor size, tumor location, operating room time, WIT, estimated blood loss, need for transfusion, perioperative
complications, baseline eGFR measurement before surgery, last eGFR measurement within 6 mo of surgery, and
change in last eGFR measurement with respect to baseline. The eGFR was calculated using the Modification
of Diet in Renal Disease formula.
Results: Demographic and perioperative data regarding the overall population include mean patient age of
61 yr (range: 20-83) and mean tumor size of 3,62 cm (range: 1-7). The off-clamp group was associated with
significantly shorter operative time, higher EBL, higher last eGFR (p<0.001), and smaller decrease in eGFR
(p<0.001). There were no differences in postoperative complication rates or transfusion rates between the
groups.
Discussion and Conclusions: There is compelling evidence to support the idea that the preservation of renal
function is associated with benefits such as increased overall survival, decreased other-cause mortality, and
decreased cardiovascular adverse events. The precise impact of warm ischemia on long-term renal function
remains unclear. However, we believe that minimizing WIT can help preserve long-term renal function. With
an appropriately selected patient group and adequate surgeon experience, off-clamp partial nephrectomy is
safe and feasible. Moreover our findings show that the off-clamp approach is associated with less progression
to renal insufficiency and better kidney function preservation. Off-clamp RPN patients had a higher eGFR
recorded at last postoperative follow-up and a significantly smaller eGFR percentage decrease.
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F. Porpiglia, R. Bertolo, D. Amparore, G. Cattaneo, I. Morra, R.M. Scarpa, C. Fiori
Aim of the study
Laparoscopic Partial Nephrectomy (LPN), currently considered the gold standard procedurein the surgical
management of T1 renal tumors, is continuously evolving. Arecent alternative to conventional laparoscopy
when looking for virtually scarless surgery is mini-laparoscopy, nowadays no Literature data are available
about this approach in a LPN setting. Aim of the present study is to evaluate feasibility and efficacy of our
retroperitoneal minilaparoscopic-LPN series.
From January to March 2014 we enrolled in this prospective study all patients candidate toLPN with the
following preoperative features: BMI<30, single exophitic renal mass <4 cm located in the posterior face
of the kidney (PADUA score <8),noprevious retroperitoneal surgery. All patients underwent minilap-LPN,
using three 3.9 laparoscopic ports, 3-mm diameter instruments and a standard 10-mm camera port. All preoperative, intraoperative, postoperative (until discharge) and pathological data were recorded; postoperative
complications were classified using Clavien-Dindo system.
Results
15 patients were enrolled in the present study; mean age and BMI were 61.4 years and 24.1 respectively.
In 3/15 cases (20%) Charlson score was >1. Mean size of the lesions was 29.9 mm, in 10/15 cases (66.6%)
the exophitic rate of lesions was >50%. The PADUA score was 6 in 5/15 (33.3%), 7 in 7/15 (46.6%) and 8
in 3/15 (20%) cases respectively. Mean operative time was 86.5 min; all surgeries were performed without
clamping of renal artery, with a mean of 78 ml blood loss. No intra-operative complications were recorded and only in one case a postoperative bleeding required transfusions (Clavien 2). Concerning functional
variables no significant differences were recorded between preoperative and discharge-day serum creatinine
(from 0.91 to 0.95 mg/dl) and eGFR (from 78.4 to 72.8 ml/min/1.73 m2) mean values. Mean hospital stay
was 4 days. Concerning pathologic results 11lesions were malignant (5 cc-RCC, 4 p-RCC and 2 cromophobes) and 4 lesions benign (2 angiomyolipomas and 2 oncocytomas).
Discussion
Results of our study suggest that the use of mini-laparoscopic approach for NPL in selected
Conclusions
In our opinion minilap-LPN can be avalid option of choice in the management of low surgical complexity
renal masses. A strong need of laparoscopic experience is required to approach this kind of surgery.
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ROBOT-ASSISTED PARTIAL NEPHRECTOMY FOR CT1B-T2 RENAL TUMORS:
PERIOPERATIVE OUTCOMES FROM A LARGE MULTICENTRE INTERNATIONAL DATASET
(VATTIKUTI GLOBAL QUALITY INITIATIVE ON ROBOTIC UROLOGIC SURGERY)
ROBOT-ASSISTED VERSUS LAPAROSCOPIC PARTIAL NEPHRECTOMY. A MULTICENTER
MATCHED-PAIR ANALYSIS
A. Volpe, C. Rogers, A. Mottrie, R. Ahlawat, N. Buffi, D. Moon, S. Rawal, F. Porpiglia, B. Challacombe, V.
Ficarra, M. Bhandari, R. Abaza (Aalst, Belgium)
Aim of the study
Robot-assisted partial nephrectomy (RAPN) has been shown to be an effective minimally invasive treatment
for small renal tumors with similar perioperative results and decreased warm ischemia time (WIT) compared
to conventional laparoscopic partial nephrectomy. The robotic technology has the potential to expand the
indications of minimally invasive nephron-sparing surgery to more challenging renal lesions. However, the
outcomes of RAPN for larger, cT1b-T2 renal tumors have been reported only in relatively small and mainly
single-institutional experiences.
293 patients who underwent RAPN for a cT1b-T2 renal tumor between October 2006 and July 2013 were
identified from a multi-institutional retrospective database including 1011 cases of RAPN from 9 tertiary
robotic centres in Europe, North America, India and Australia. Intraoperative outcomes, pathological
outcomes and complications were assessed. Complications were graded according to the Clavien-Dindo
classification system.
Results
264 RAPNs were performed for cT1b tumors (median size 48 mm, IQR 42-54) and 29 for cT2 tumors
(median size 80 mm, IQR 72-94). Median age of patients was 58 years and the average Charlson
comorbidity score was 2 (IQR 0-3). Median operative time was 210 minutes (IQR 158-256). Median
estimated blood loss and WIT were 150 ml (IQR 100-300) and 20 minutes (IQR 16-24), respectively. Ten
intraoperative complications occurred (3.4%). Postoperative complications were observed in 58 cases
(19.8%) and 23 (8.6%) were Clavien grade ≥3. Hospital stay was on average 3 days (IQR 1-5). A benign
pathology was found in 46 cases (16.1%). Fourteen tumors (4.8%) were pT3a at final pathology and positive
surgical margins were detected in 11 cases (3.8%).
Discussion
nn
A. Minervini, G. Vittori, F. Porpiglia, A. Antonelli, S. Bhayani, G. Guazzoni, N. Longo, C. Fiori, R. Bertolo,
G. Martorana, G. Morgia, A. Mottrie, J. Porter, C. Simeone, S. Serni, F. Zattoni, M. Carini, V. Ficarra
(Firenze)
Aim of the study
only few studies compared the results of the two main alternatives of minimally invasive treatment of renal
cell carcinoma (RCC), providing conflicting results regarding which technique provides more frequently
the maximum success from a surgical perspective. Our aim was to compare the Trifecta outcome in a large
multicenter matched series of patients treated with laparoscopic partial nephrectomy (LPN) or roboticassisted partial nephrectomy (RPN) for cT1 RCC.
Patients of the RPN arm, treated from Sept 2008 to Sept 2010, were extracted from a multicenter,
international database including cases done in four high volume centers Patients of the LPN arm, treated
between Jan 2009 and Dec 2012, were extracted from the REgistry of COnservative Renal surgery
database(RECORd) promoted by LUNA foundation of the Italian Society of Urology. We undertook a
matched-pair analysis for patients age, tumor size, longitudinal location (polar vs mid pole) and exophytic
rate (≥50% exophytic vs others), with a 1:1 ratio with respect to the surgical approach, including 306
patients in both LPN and RPN groups. Perioperative outcomes were compared with univariate analysis,
and a correlation analysis assessed clinical variables associated with the Trifecta outcome, defined as warm
ischemia time (WIT)
Results
groups were comparable in gender distribution and preoperative renal function, as well as the matched
variables. In RPN vs. LPN group, no significant differences resulted regarding operative time, perioperative
complications (9.2% and 11.1%,p=0.43), reoperation rate for Clavien grade≥3 complications (2% vs.
2.6%,p=0.97) positive surgical margin rate (4.2%vs.2.5%;p=0.22) and pathological and short-term
functional results. The pedicle clamping was used significantly more often in the RPN group(87.9% vs.
49%,p
Discussion
i
Conclusions
RAPN for cT1b-T2 tumors is feasible with limited blood loss and acceptable WIT, complication and positive
surgical margin rate in centres with advanced robotic expertise.
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Conclusions
the current multicenter analysis reveals that, in experienced hands, the trifecta can be achieved in ¾ of
patients both with LPN and RPN without significant differences. Additional studies are needed to investigate
this issue further.
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SIMPLE TUMOR ENUCLEATION AND STANDARD PARTIAL NEPHRECTOMY HAVE
SIMILAR PERIOPERATIVE RESULTS AND TRIFECTA OUTCOMES: COMPARISON BASED
ON A MATCHED-PAIR ANALYSIS OF 400 PATIENTS FROM THE DEFINITIVE RESULTS OF
RECORD1 PROJECT
SLIDING CLIPS VERSUS SEPARATED STITCHES RENORRAPHY AT TIME OF
LOMBOTOMIC PARTIAL NEPHRECTOMY: A PROSPECTIVE RANDOMIZED TRIAL
A. Minervini, A. Antonelli, G. Bianchi, A. Tuccio, C. Fiori, S. Giancane, N. Longo, A. Mari, G. Martorana,
V. Mirone, G. Morgia, F. Porpiglia, B. Rocco, B. Rovereto, R. Schiavina, S. Serni, C. Simeone, A. Volpe, V.
Ficarra, M. Carini (Firenze)
Aim of the study
to compare two different renorrhaphy techniques during open lombotomic partial nephrectomy
Aim of the study
Simple tumor enucleation and Standard partial nephrectomy have similar perioperative results and trifecta
outcomes: comparison based on a matched-pair analysis of 400 patients from the definitive results of
RECORd1 project
1055 patients treated with nephron sparing surgery (NSS) between January 2009 and December 2012
were evaluated. Overall, 200 patients who underwent STE were retrospectively matched with 200 patients
treated with SPN through a propensity score analysis based on preoperative variables. An intraoperative,
early post-operative and Trifecta comparison was performed between the two groups. Trifecta was defined
as simultaneous ischemia < 25 min, no surgical complication and absence of positive surgical margin
(PSM). Multivariable analysis was applied to predict factors independently associated with negative trifecta
outcome.
Results
STE and SPN presented similar WIT (18 vs 17 min) and intraoperative blood loss (200 vs 196 cc). STE
and SPN were also associated with similar surgical complication (11% vs 7.5%), surgical Clavien 3 (3% in
both groups) and Trifecta outcome (74% vs 73.5%) rate. The incidence of PSM was significantly lower in
patients treated with STE (1% vs 5%; p=0.02). Clinical diameter was significantly higher in patients with
negative trifecta outcome (3.5 vs 3 cm, p 0.01), but at the multivariable analysis, only
Discussion
The RECORd Project is a 4-Year prospective observational multicenter study promoted by the Italian
Society of Urology. This study confirms the results sorted out from the partial data of RECORd project. SE
and SPN presented similar overall and major surgical complications, PSM are significantly higher in PN.
Tumor diameter and tumor endophytical growth are the main predictive factors of no trifecta achieving.
Conclusions
To our knowledge this is the first multicenter matched-pair comparison of patients treated by STE and SPN.
The two techniques seems to have similar perioperative and trifecta outcomes. STE have lower rate of
PSM, but it needs further confirmation in a prospective study with central pathological revision. Endophytic
growth pattern remains an important predictive factor of negative trifecta outcome.
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L. Gallo, R. De Domenico, G. Quarto, R. Muscariello, D. Sorrentino, S. Perdonà (Napoli)
All patients candidates to conservative renal surgery were recruited.Subjects were randomized in two
homogeneous and equal groups according to body mass index (BMI) and R.E.N.A.L. nephrometry score
(min 3 – max 12). We performed in both groups an open flank approach and the same tecnique for tumor
resection. We executed two different techniques of renorraphy. In group one separated CT-X needles
Vicryl® 0 sutures were placed on both sides of renal wound. A different numbers of sutures were placed
according to the size of the renal defect. Afterwards the two free ends of the suture were tied together above
a bolster of Tabotamb® to enforce the pressure on the resection area and to avoid tearing out the sutures. In
group two it was performed a “sliding clips” renorraphy technique: a knot was tied at the end of a 0 PDS®
suture. Above the knot, it was placed an Hem-o-Lock®. A running suture were then performed placing at
each passage of the needle at both side of the renal wound an Hem-o-Lock®. To tighten, the loose end of
each suture was grasped with a needle driver and tension was applied perpendicular to the capsule in order
to minimize the risk of tearing. In both groups it was applied at the end of the renorraphy a Flowseal®
solution on the renal wound to ensure haemostasis. All surgeries were performed by the same experienced
surgeon (SP). The outcome measurement was the comparison in both groups of X2 distribution of the
following outcomes: warm ischaemic time, existimated blood loss, hospital stay and drainage leakage.
Results
40 patients entered the study and were assigned equally to the two groups. Results were the following
respectively for group one (separated stitches) and group two (sliding clips). Renal score: 5,85 ± 1,46 ;5,9
± 1,48(p 0,73). BMI: 27,8 ± 4,7 ; 28,15 ± 4,4 (p:1). Warm ischaemic time (minutes):18,45 ± 2,72 ;23,75 ±
1,77 (p0,027). Existimated blood loss (ml): 158,2 ± 61,5 : 170,75 ± 65 (p 0,002). Hospital stay (days): 6,9 ±
1,2 ; 6,1 ± 0,9 (p 0,99). Drainage leakage (ml): 167 ± 46,8 ; 139,5 ± 48.4 (p 0,001). All patients were safely
discharged without major complications. One patient of each group required
Discussion
Partial nephrectomy is the gold standard for treatment of small renal masses. This surgical procedure can be
performed either by open, classic laparoscopic or robotic assisted approach. Independently by the access,
there is still a lack of consensus about the best method to execute renorrhaphy, the most crucial part of this
intervention
Conclusions
Sliding clips renorraphy provided a lower leakage trough the drainage than separated stitches suture but
increased blood loss and required an higher ischaemic time. No differences were found at hospital stay
between the two groups
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SUTURELESS LAPAROSCOPIC PARTIAL NEPHRECTOMY BY USING FIBRIN GEL
(TISSUCOL®) IS ABLE TO REDUCE THE ISCHEMIA TIME WITH RENAL FUNCTION
PRESEVING
TRI MATCH COMPARISON OF THE EFFICACY OF FLOSEAL® VS TACHOSIL® VS NO
HEMOSTATIC AGENTS FOR PARTIAL NEPHRECTOMY: RESULTS FROM A LARGE
MULTICENTER DATASET (RECORD PROJECT)
D. Tiscione, T. Cai, L. Luciani, V. Vattovani, G. Malossini (Trento)
A. Antonelli, A. Minervini, A. Mari, G. Bianchi, C. Fiori, A. Lapini, N. Longo, G. Martorana, V. Mirone,
G. Morgia, F. Porpiglia, B. Rocco, R. Schiavina, S. Serni, M. Sodano, C. Terrone, A. Volpe, F. Zattoni, V.
Ficarra, C. Simeone, M. Carini (Brescia)
Aim of the study
Minimizing renal ischemia time is one of the most technically challenging step in laparoscopic partial
nephrectomy (LPN). The aim of the present study was to evaluate the efficacy of sutureless LPN by using a
fibrin gel (TISSUCOL®) in order to minimize renal ischemia time and preserve the kidney function, when
compared with LPN standard suturing.
Between October 2008 and July 2009, 19 patients (mean age 58.3±7.1) underwent sutureless LPN by using
of TISSUCOL® and compared with a series of 21 patients (mean age 57.9±7.5) who had undergone LPN
standard suturing in the same period, considering the control group. All procedures were performed by
the same surgeon. The following parameters were recorded: patient demographics, Charlson Comorbidity
Index, tumour characteristics by using RENAL score, warm ischemia and operative time, estimated blood
loss, mean hospital stay, post-operative complications by using Clavien-Dindo classification, renal function
parameters, pathologic and follow-up data. The main outcome measure was the renal ischemia time and the
kidney function preservation.
Results
Median warm ischemia time was 13 minutes (range 11-19) in the TISSUCOL® group, while 19 (range 1729) in the control group, with a statistically significant difference (p
Discussion
LPN is increasingly performed all over the world and actually represents a valid procedure for the
management of small renal tumours, but some technical aspects are still to improve. Here, we demonstrated
that sutureless LPN with TISSUCOL® is able to reduce the warm ischemia, total operative time and
preserve kidney function, without severe complications, when compared with standard suturing LPN. In
particular, renal suturing during LPN is a difficult step, that increases operative time and warm ischemia
time.
Conclusions
Sutureless LPN with TISSUCOL® is a safe method and is able to reduce the warm ischemia, total operative
time and preserve kidney function, without severe complications, when compared with standard suturing
LPN.
Aim of the study
The aim of this study is to investigate the efficacy of hemostatic agents (HA) in Nephron Sparing Surgery
(NSS). A three-matched comparison between patients treated with no HA, with Tachosil® and with
Floseal® was performed.
Observational multicentre study (RECORd Project) collects the data of 1055 patients who underwent PN
between January 2009 and December 2012 at 19 Italian centres. Cases treated with more than one HA or
with HA other than Floseal® or Tachosil® were excluded. A tri-match propensity score analysis was applied
to create 3 groups - no HA group, Floseal® group, Tachosil® group - balanced for gender, age, surgical
indication (elective/relative vs imperative), clinical stage (cT1a vs cT1b), tumour growth pattern, surgical
approach (open vs minimally invasive), surgical technique (standard PN vs simple enucleation), preoperative
haemoglobin and preoperative creatinine. The three groups were compared regarding the main intra and
post-operative outcomes.
Results
The study excluded 255 patients treated with more than one HA and were submitted 131 cases to no
HA group, 200 to Tachosil® group, 489 to Floseal® group. In the original cohort significant differences
among groups in terms of patient, tumor and surgical features were detected, so that a tri-match analysis
for 66 triplets well balanced triplets were performed. The three matched cohorts presented a significant
difference in EBL, lower in the Floseal® group, but this result lost significance if clinical important EBL
was considered (>400 cc). No significant difference was found between three groups regarding medical
and surgical post-operative overall complications, surgical haemorrhagic Clavien 2 and 3 complications,
variation of haemoglobin and creatinine values between preoperative and 3rd post-operative day.
Discussion
In order to reduce hemorrhage during NSS the use of biological HA is increasing, but literature on this
subject is limited to some cases series, few retrospective studies and one randomized trial. Among the three
groups, no differences were detected in the rates of medical and surgical complications, transfusion and
re-intervention due to bleeding, as in variations between pre and postoperative levels of hemoglobin and
glomerular filtration rate, overall and pairwise. Therefore, from these results, it seems that HA cannot exert
any significantly protective effect against bleeding with respect to standard suturing. A possible explication
is that HA is often used improperly or indiscriminately. This statement is indirectly confirmed by the fact
that, in spite of their frequent use, a reduction in the rate of bleeding was not observed in recent with respect
to past series of PN.
Conclusions
No differences in terms of overall and bleeding complications were detected among patients submitted to
NSS without using HA, using Floseal® or Tachosil®. There is no clear evidence that the use of HA, in
addition to sutures, can improve haemostasis after PN.
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500 PROTESI PENIENE PROPOSTE , IMPIANTATE E SEGUITE DALLO STESSO
SPECIALISTA. CONSIDERAZIONI GENERALI
RELIABILITY AND SAFETY OF DYNAMIC SENTINEL NODE BIOPSY (DSNB) IN CLINICALLY
NEGATIVE INGUINAL NODES (cN0) PENILE SQUAMOUS CELL CARCINOMA (pSCC).
Catanzaro M.1, Lorenzoni A.2, Nicolai N. 1, Torelli T.1, Maccauro M. 2, Aliberti G. 2, Piva L. 1, Maffezzini
M. 1, Stagni S. 1, Biasoni D. 1, Calandriello M. 1, Necchi A.3, Giannatempo P. 3, Farè E. 3, Raggi D. 3,
Marongiu M. 3, Crippa F., 2 Salvioni R1.
1. Urology Department. Fondazione IRCCS Istituto Nazionale Tumori, Milan Italy
2. Nuclear Medicine Department. Fondazione IRCCS Istituto Nazionale Tumori, Milan Italy
3. Medical Oncology Unit. Fondazione IRCCS Istituto Nazionale Tumori, Milan Italy
D. Pozza, C. Pozza, M. Musy, M. Pozza (Roma)
Scopo del lavoro
Considerazioni generali su 500 protesi peniene, di varie tipologie e caratteristiche, impiantate dallo stesso
specialista tra il 1987 ed il 2014.
Materiali e metodi
A pazienti di età compresa tra 18 e 86 anni(vm:48,0) affetti da varie patologie che impedivano una adeguata
erezione (vascolari venosi 27,6%, vascolari arteriosi 27,6%, IPP 22,8%, diabete 13,6%, psico-morfologici
8,4%)e che non rispondevano ad altre modalità terapeutiche (5PDEi, PGE1), sono state consigliate e
sono stati sottoposti ad impianto Protesico Penieno. Sono state utilizzate quasi tutte le protesi peniene
ottenibili nel mercato medico italiano. 362 Protesi semirigide-malleabili(98 Eurogest,68 Mentor Acuform,
95 Silmed,35 Subrini, 28 SSDA-GIS, 22 Jonas, 20 Duraphase, 14 Omniphase, 12 Small Carrion) e 138
Idrauliche di cui 21 mono o bicomponenti (10 Hydroflex, 8 Dynaflex, 3 Ambicor,) e 117 tricomponenti (30
MentorAlphaI, 24 AMS700CX 22 MentorMarkII,20 ColoplastTitan, , 18 AMS700Ultrex, 3 AMS700 LGX.
Abbiamo utilizzato vari schemi di antibiotico terapia anche se da 10 anni utilizziamo uno schema fisso
(Ciprofloxacina, Gentamicina, Ceftriaxone) tutti i paz. sono stati seguiti, operati in case di cura private e
seguiti nel tempo dallo stesso operatore (DP)
Risultati
La degenza dei paz. è variata da 1 a 4 giorni (vm: 2,2 notti). Abbiamo registrato nelle protesi semirigide 8
(0,02%) casi di rotture meccaniche, 8 (0,02%) casi di estrusione apicale, 5 (0,01%) malposizionamento dei
cilindri protesici. Nei casi di protesi idrauliche, 80% delle Hydroflex e 75% delle Dynaflex hanno avuto
malfunzionamento. Rottura dei cilindri, aneurismi,erosione delle pompe scrotali, rottura dei tubetti di
connessione in 12 (16,6%) protesi Mentor-Coloplast ed in 10 (22,2%) AMS700. riportiamo 38 casi (7,6%)
di infezioni nel periodo p.op., con espianto di 2 protesi malleabili (0,5%) e 1 idraulica (0,7%). In complesso
abbiamo dovuto espiantare 21 protesi malleabili (5,8%), 14 protesi idrauliche monocomponenti (77%) e
22 idrauliche tricomponenti (18,8%). Non possiamo escludere che altre protesi siano state espiantate in
altre realtà sanitarie senza esserne informati. Solo 3 casi di insoddisfazione assoluta legati alla protesi che
hanno portato all’espianto in 2 casi. Il tasso di globale soddisfazione nei pazienti controllati a distanza è
estremamente elevato (90%)
Discussione
La soluzione protesica appare essere una buona e soddisfacente modalità di risoluzione del Deficit Erettile.
Appare importante un buon approccio al paziente ed alle sue motivazioni, anche di coppia. La scelta della
protesi malleabile o idraulica dovrebbe avvenire sulla base di considerazioni anatomiche e patofisiologiche e
non su fattori economici o di disponibilità. Una buona profilassi igienica ed antibiotica sembrerebbe in grado
di limitare il rischio, sempre temibile nella chirurgia protesica, delle infezioni batteriche.
Conclusioni
Le protesi peniene, sia di tipo malleabile che idraulico, rappresentano una soluzione assolutamente valida
per riottenere una capacità penetrativa sessuale.
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Scopo del lavoro
The aim of the study is to assess the false negative rate, negative predictive value (NPV) and sensitivity of
DSNB in cN0 patients with pSCC.
Materiali e metodi
From 01-2000 to 12-2013, 110 patients (pts) underwent DSNB: 89 patients (mean age 59 years, range
21-80) cN0 pT1-3 pSCC, stated by physical and ultrasound groins examination, were retrieved from our
prospectically kept database. The lymphoscintigraphy was performed the day of the surgery to identify the
inguinal sentinel nodes which was intraoperatively detected by gamma probe and blue dye detection and then
removed. We also performed DSNB on the opposite clinical negative side in 14 patients with monolateral
clinical positive inguinal nodes.
Risultati
In 76 out of 89 patients sentinel nodes (SNs) were removed in both inguinal groin successfully. In 12 pts DSNB
was performed in one groin only and in 1 patients SN was not bilaterally identified due to absent visualization
during lymphoscintigraphy or low signal at the gamma probe during surgical procedure. Consequently SN
was not identified (cNx) in 14 out of 178 inguinal groins (7.8%), while the procedure was completed in
164/178 (92.2%) groins. In 11/164 groins (6.7%) we had positive sentinel node, which was followed by ILND:
6 had pN1 (SN was the only one pathologic node), 5 pN2-N3 disease (TNM 2002) . After a median followup of 11 months (range 2-26 months) 12 out of 153 (7.8%) groins with negative SNB developed inguinal
metastases; these pts underwent to radical nodal surgery: 2 pts had pN1, 6 pts pN2 and 2 pts pN3 (2 pts had
bilateral positive groins). 3/14 groins (21.4%) without SN identification had positive nodes: 1 pN1 underwent
ILND at the same time of DSNB, 2 pN2 at follow-up (2 and 13 months). On the monolateral DSNB we found
12 negative sentinel node and 2 positive nodes. The 2 pts with positive DSNB underwent ILND: 1 pt had
pN1, 1 pt pN2. One pt with negative mDSNB (1/12) relapsed at 25 months follow-up (pN2), 11/12 (91.7%)
are negative at median follow-up of 58 months (range 23-114).
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Discussione
Overall, we recorded 26/178 affected groin (15%). As a whole ILND could be spared in 85% of groins
(152/178). On the other hand the false negative rate was 7.3% (12/164) leading to a relatively good NPV of 86%
(141/164), but to a fair sensitivity of 48% (11/23). The efficiency rate of the whole procedure (considering all
178 groins we intended to explore) is even lower as we detected only 11/26 (42.3%) of the metastatic groins.
Conclusioni
DSNB is able to spare ILND to 85% of our patients: the NVP was 86% and sensitivity 48%, nethertheless the
efficiency rate of the intention to diagnose was low, as only 42% of metastatic nodes could be early detected
and follow-up is mandatory also in case of negative bilateral sentinel node biopsy. DSNB shows good
reliability also in patients with monolateral cN+ (NPV 78.6%, FNR 8.3%).
GENITOPLASTICA FEMMINILIZZANTE NEL DISTURBO DELL’IDENTITA’ DI
GENERE,TECNICA DI CONFEZIONAMENTO DEL NEOCLITORIDE DI MEATOPLASTICA
URETRALE, ASPETTI FUNZIONALI ED ESTETICI
S. Caroassai, A. Delle Rose, N. Stomaci, A. Cocci, T. Jaeger, G. Nicita (Florence)
Scopo del lavoro
Descrivere la tecnica utilizzata presso la Clinica Urologica II dell’Università degli studi di Firenze nella
conversione androginoide nei disturbi dell’identità di genere,sottolineando i vantaggi estetici e funzionali
della clitoridoplastica e della meato plastica uretrale con posizionamento a piatto dell’uretra per la
formazione del neomeato.
Materiali e metodi
Abbiamo sottoposto 11 pazienti a intervento di conversione androginoide per disturbo dell’identità di genere
con la medesima tecnica chirurgica in tempo unico.La tecnica in tempo unico da noi praticata prevede
orchifunicolectomia bilaterale seguita da disassemblamento penieno:la cute dell’asta unitamente al dartos
viene separata dai corpi cavernosi ponendo particolare attenzione nel preservare il fascio vascolo-nervoso
del pene.Creato tra retto e prostata lo spazio per la neovagina si procede al suo confezionamento con la
tubolarizzazione della cute del pene nella cui porzione dorsale vengono eseguite 2 incisioni per il passaggio
del neoclitoride e dell’uretra.Per la formazione del primo viene utilizzata la porzione dorsale del glande che
rimane attaccata al fascio vasolo-nervoso penieno che contribuirà a formare il monte di venere.Circa 1,5
cm sotto il neoclitoride viene praticata la seconda incisione per l’esteriorizzazione uretrale. L’uretra viene
spatolata superiormente quindi suturata alla cute creando nella sua porzione superiore una zona pianeggiante
centralmente e lievemente rilevata ai bordi che ricrea il vestibolo dell’uretra e del clitoride,inoltre viene
ridotta la componente spongiosa.Per la creazione delle grandi labbra viene utilizzata la cute scrotale che
mostra caratteristiche simili,su cui viene creata una plicatura mediante posizionamento di punti atta a
replicare la forma delle labbra stesse.Le pazienti sono state studiate mediante colloquio,visita urologica e
flussometria pre e post operatoria a 3-6-12 mesi.
Risultati
In tutte le pazienti con follow up medio di 16 mesi(range 3-43)sottoposte a questo tipo di tecnica si sono
ottenuti risultati soddisfacenti sia in termini estetici che funzionali.In particolare a tre mesi dall’intervento
non si sono verificate stenosi del neomaeato uretrale.Infatti il Qmax medio pre operatorio è risultato 18,3
ml/s e mentre all’ultimo controllo postoperatorio è 19,4 ml/s le pazienti riferiscono una buona sensibilità del
neoclitoride.Il risultato estetico è risultato soddisfacente.
Discussione
Il mantenimento della sensibilità neoclitoridea è associata a maggiore soddisfazione sessuale.Lo
spatolamento uretrale permette di prevenire la formazione di stenosi del neomeato garantendo un buon
risultato funzionale ed estetico,la riduzione del corpo spongioso dell’uretra previene l’erezione del moncone
uretrale che porta a disturbi durante il rapporto sessuale.
Conclusioni
La tecnica di spatolatura e sezione del corpo spongioso dell’uretra permette buoni risultati estetici e
funzionali attività e la conservazione della sensibilità del neoclitoride e di soddisfazione estetica personale e
del partner.
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IL PATCH DERMICO NELLA CHIRURGIA DELL’IPP: FOLLOW-UP A 18 ANNI
IMPLANT OF AN INTRACORPORAL PHANTOM IN ORDER TO PREVENT PENILE
SHORTENING AFTER PENILE PROSTHESIS REMOVAL DUE TO PROSTHETIC DEVICE
INFECTION OR DISTAL URETHRAL EROSION
A. De Rose, A. Simonato, F. Peraldo, G. Carmignani (Genova )
Scopo del lavoro
La terapia chirurgica della Induratio Penis Plastica (IPP) dovrebbe essere ispirata a criteri di massima
conservatività e minima invasività, considerando che con l’intervento chirurgico non viene ricercata la
guarigione della malattia, ma il ripristino della funzione sessuale. Per questo motivo, quando siamo di
fronte ad un pene eccessivamente piccolo e curvo si impone una chirurgia più aggressiva con l’incisione o
escissione della placca e l’utilizzo di un patch autologo o eterologo. Scopo di questo lavoro è stato quello di
valutare clinicamente lo stato del patch dermico a distanza di 18 dall’intervento di corporoplastica.
Materiali e metodi
Dal 1994 al 1996 105 soggetti di età compresa tra 52 e 67 anni sono giunti alla nostra osservazione
per incurvamento dorsale (84 pz) e dorsolaterale sn (21 pz) con curvatura compresa tra 35 e 90°, che
ostacolava la penetrazione ma con erezione conservata. 55 sono stati sottoposti ad incisione della
placca e posizionamento di patch dermico. Dopo 18 anni 45 soggetti sono stati valutati mediante un test
autovalutativo soggettivo riguardante le variazioni pre e post operatorie dei seguenti parametri: rigidità,
incurvamento, sensibilità glandulare, lunghezza del pene e soddisfazione del risultato globale. Tutti sono
stati sottoposti ad ecografia dinamica del pene dopo puntura di 10 microgrammi di PGE1
Risultati
75% dei pazienti ha riferito di essere globalmente soddisfatto. La valutazione soggettiva del paziente
ed obiettiva del medico però non sempre sono risultate sovrapponibili, mettendo in evidenza come la
soddisfazione del paziente, a volte, si discosti dal giudizio clinico di “successo” della scelta chirurgica
adottata. 8 pazienti assumono inibitori delle fosfodiesterasi per il rapporto sessuale e 5 devono ricorrere alla
punture intracavernosa. In 9 era presente un incurvamento tra 20 e 30° che non ostacolava la penetrazione.
All’ecografia dinamica è stata osservata , anche a distanza di molti anni, una ottima distendibile del patch
durante la fase di erezione.
Discussione
L’intervento per induratio penis plastica non è in alcun caso curativo della malattia: si tratta invece di un
intervento plastico di correzione cosmetica e funzionale. In questa ottica l’utilizzo del patch dermico, come
hanno dimostrato i risultati a distanza di 18 anni, è risultato efficace nella chirurgia di questa malattia in
quanto sembra conservare una ottima distensibilità e assicurare un’ottima cosmesi
Conclusioni
Il patch dermico autologo ha dimostrato una ottima efficacia nel follow up a lungo termine e sembra non
influenzato dai fenomeni di fibrosi e di retrazione
M. Ennas, M. Ennas, N. Morel Journel, J. Terrier, A. Benelli, A. Simonato, G. Carmignani, A. Ruffion
(Genova)
Aim of the study
Device infection is one of main complication of penile implants. The most conservative management
is complete prosthesis removal and delayed reimplantation, but it allows to shaft fibrosis, penile length
shortening and more difficult reimplantation. Aim of this study is to report our technical approach and
functional outcome in salvage procedure to manage penile prosthesis infection or urethral erosion.
From June 2009 to April 2014, 10 patients referred to our tertiary care center for a clinical suspicion of
infection of their penile prosthesis implants or distal urethral erosion due to their prosthesis and all of
them underwent a salvage procedure. All patients underwent systemic antibiotic treatment before and after
surgery. During first surgical step cultures were collected, infected prosthesis were removed and the site
irrigated with antibacterial solutions. In 8 patients a soft silicone prosthesis was placed in corpora cavernosa,
one patient underwent implantation of an inflatable prosthesis and another one of a malleable implant.
The patients were discharged the day after and they were placed on oral antibiotic treatment for 2 weeks
following this procedure. Treatment was adapted to the antibiogram results. Twelve months after the first
step 5 patients with soft implants underwent substitution of the device with an inflatable penile prosthesis.
The other 3 patients treated with a soft prosthesis implantation are already scheduled for substitution.
Results
After the first step surgery we didn’t observe prosthesis loss. Cultures were negative in 5 cases (e.g. patients
presenting urethral erosion). The 5 positive cultures showed the following infecting agents: S. epidermidis,
P. acnes, A. species and in 2 cases multibacterial infection. The 5 patients that underwent reimplantation of
an inflatable prosthesis show no infection after a mean follow up of 22,6 months.
Discussion
Penile prosthesis infection or components erosion is a unique management problem. They can be treated
conservatively with complete device removal. Alternatively a salvage procedure can be performed.
Immediate replacement of the infected prosthesis has already been described with a failure rate of 16 %.
Our 2 steps procedure, as others salvage procedures, allows to prevent corpora cavernosa fibrosis in order
to preserve penile length and to simplify delayed reimplantation. Mean operative time and hospital stay in
our series were 125 minutes and 2.4 days. We had no failed procedures. The choice of the soft implant rather
than malleable prosthesis avoid tissue ischemia and subsequently allows better wound healing and prevent
corpora cavernosa perforation. Our techniques presents some disadvantages: between first and second steps,
patients are not able to achieve penetrations; further it would subject the patient to an additional procedure.
Conclusions
Two steps salvage procedure is a feasible and safe option in the management of infected penile implants.
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LA “SLIDING TECHNIQUE” PER INDURATIO PENIS PLASTICA END-STAGE CON GRAVE
ACCORCIAMENTO DELL’ASTA:OUTCOME CHIRURGICI E SODDISFAZIONE DEI
PAZIENTI
LA BIOPSIA DINAMICA DEL LIFONODO SENTINELLA NELLA STADIAZIONE CLINICA DEL
TUMORE DEL PENE: ESPERIENZA DI DUE CENTRI DI TERZO LIVELLO.
M. Timpano, D. Ralph, F. Colombo, C. Dadone, M. Falcone, C. Ceruti, O. Sedigh, E. Galletto, F. Kuehhas,
M. Preto, B. Frea, L. Rolle (Torino)
Scopo del lavoro
La malattia di La Peyronie (IPP) si manifesta tipicamente con deformazione del pene, deficit erettile e dolore
in erezione. Il recurvatum può essere corretto con tecniche di Nesbit o con chirurgia di placca. Maggiori
problemi pone il trattamento dell’accorciamento, presente soprattutto nelle fase terminali della patologia.
Presentiamo i risultati della “Sliding Technique” in termini di outcome chirugici, soddisfazione dei pazienti
e complicanze post-operatorie in un coorte di 21 pazienti sottoposti ad intervento in 3 centri uro-andrologici
europei
Materiali e metodi
Sono stati selezionati 21 pazienti dal Giugno 2010 a Marzo 2014 affetti da malattia di La Peyronie endstage, con deficit erettile grave e importante accorciamento dell’asta, associato ad un incurvamento minore
di 30°. Tutti gli interventi sono stati eseguiti in anestesia spinale. La tecnica utilizzata è stata la “sliding
technique” sec. Rolle, con innesto di doppio graft dorso-ventrale e posizionamento di protesi peniena
tricomponente in 14 casi (AMS 700 CX Inhibizone MS Pump), in 2 casi (Titan OTR Pump- Coloplast)
semirigida in 5 casi (AMS Spectra).
Risultati
In tutti i casi l’intervento descritto ci ha permesso di ottenere un reale allungamento del pene di 2,9 cm. Il
tempo operatorio medio è stato di 2 ore e 50 min. Non vi sono state complicanze intraoperatorie maggiori.
Nel post operatorio è stata documentata una sola complicanza maggiore in termini di necrosi cutanea distale
dell’asta con successiva infezione protesica che ha richiesto la rimozione dell’impianto. Il valore del IIEF ad
un follow-up medio di circa un anno risulta 58,2, mentre l’EDITS a 6 mesi si attesta a 47.
Discussione
I nostri dati dimostrano come la sliding technique, in casi selezionati di IPP end stage, permetta di otttenere
un allungamento significativo dell’asta, con ottimi risultati funzionali anche a lungo termine. Tale tecnica va
riservata a centri di riferimento con un’esperienza importante nella chirurgia andrologica complessa.
Conclusioni
La “Sliding Technique” appare uno strumento affidabile e gravato da una bassa incidenza di complicanze nel
trattamento del IPP end stage con grave accorciamento dell’asta.
A. Palazzetti, J. Gaya, O. Sedigh, M. Preto, M. Falcone, J. Palou, B. Frea (Torino)
Scopo del lavoro
Il tasso di cura nella neoplasia del pene è passato dal 50% nell’anno 2000 all’80% negli ultimi anni grazie a
miglioramenti tecnici nella sua gestione. Tra questi spicca il miglioramento della stadiazione clinica a livello
inguinale attraverso la biopsia dinamica del linfonodo sentinella (BD-LS) che ha dimostrato migliorare la
sopravvivenza rispetto al solo follow-up clinico con una bassa morbidità rispetto ai pazienti sottoposto a
linfadenectomia (LAD) inguinale, con una specificità del 100% e una sensibilità del 90-95%. Presentiamo
l’esperienza di 2 centri di terzo livello che realizzano la presente tecnica come parte del protocollo standard
di terapia del tumore del pene
Materiali e metodi
Analisi retrospettiva di 40 pazienti affetti da tumore del pene e sottoposti a BD-LS in due centri distinti
(Clinica Urologica di Torino Città della Salute e della Scienza e Fundaciò Puigvert Barcellona). Indicazione:
tutti i casi di linfonodi inguinali non palpabili nè sospetti all’ecografia, indipendentemente dalla stadiazione
clinica della lesione peniena. Marcaggio realizzato almeno 3 ore prima della procedura con Tc-99. Sono
state analizzate: anatomia patologica (AP) della lesione peniena, timing della BD-LS (sincrona/metacrona),
il tempo chirurgico, AP del LS, il risultato della LAD inguinale nei casi di LS positivo, la mediana di
followup e il tasso di recidiva nei pazienti con LS negativo
Risultati
AP lesioni peniene: 3 CIS, 10 T1aG1, 8 T1aG2, 1 T1aG2 + CIS, 2 T1bG2, 6 T2G1, 5 T2G2, 1 T2G2 +
CIS, 1 T2G3, 3 T3G2. In più dell’80% dei casi la captazione inguinale era bilaterale. Nel 75% la BD-LS
è stata sincrona. Mediana tempo chirurgico: 32 minuti. In 8 casi su 40 l’AP del LS è risultata positiva per
neoplasia essendo poi solo in 3 casi su 8 positiva anche la LAD inguinale. In nessun caso di LS negativo è
poi comparsa recidiva locale di malattia con una mediana di follow-up di 24,6 mesi. Non è stata osservata
nessuna complicanza secondaria alla BD-LS nè è risultato allungato il decorso post operatorio a causa di tale
procedura
Discussione
La stadiazione clinica linfonodale del tumore del pene è ancora oggetto di studio e validazione. La BD-LS è
una tecnica che permette di identificare una vera popolazione a rischio e di selezionare per la LAD inguinale
solo i pazienti con metastasi patologicamente dimostrate avendo come risultato finale un miglioramento
della sopravvivenza del paziente. La sua semplicità chirurgica e l’assenza di importanti complicanze la
rendono una tecnica appetibile e facilmente fruibile per i centri che ne posseggano la tecnologia il tutto
associato ad una percentuale esigua di falsi positivi dimostrata dall’assenza di recidive locali linfonodali a
medio raggio temporale
Conclusioni
La BD-LS è una procedura facilmente riproducibile, rapida, realizzabile contemporáneamente al trattamento
della lesione peniena. Data la mancanza di recidiva locale osservata durante un follow-up di media durata
nei pazienti con LS negativo la tecnica pare fornire una stadiazione clinica linfonodale corretta
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LA CURVA DI APPRENDIMENTO E LE COMPLICANZE POST-OPERATORIE DELLA
CHIRURGIA DI RIASSEGNAZIONE DEI CARATTERI SESSUALI IN SENSO ANDROGINOIDE: UNO STUDIO PROSPETTICO UNICENTRICO
OUTCOME FUNZIONALI DELLA CORPOROPLASTICA CON PATCH DI MUCOSA BUCCALE
IN PAZIENTI CON MALATTIA DI LA PEYRONIE
M. Falcone, M. Timpano, C. Ceruti, O. Sedigh, M. Preto, M. Sibona, B. Frea, L. Rolle (Torino)
Scopo del lavoro
La riassegnazione chirurgica dei caratteri sessuali (RCS) in senso andro-ginoide è una procedura complessa
riservata ai pazienti affetti da Disforia di Genere. Lo scopo del nostro studio è quello di riportare la curva di
apprendimento dell’equipe chirurgica e le complicanze post-operatorie verificatesi nei pazienti sottoposti a
tale intervento
Materiali e metodi
Nella nostra Divisione Urologica, a partire da Maggio 2005 fino a Febbraio 2014, sono stati sottoposti ad
intervento di RCS in senso MtoF 52 pazienti. La tecnica utilizzata in tutti i pazienti é stata la vaginoplastica
con lembo cutaneo peno-scrotale sec.Jones modificata. Tutti gli interventi sono stati eseguiti dalla medesima
equipe composta da 4 chirurghi.
Risultati
All’interno della nostra casistica non sono state registrate complicanze intra-operatorie maggiori. Le
complicanze post-operatorie si sono verificate in 20 pazienti (38,4%) di cui 9 hanno sviluppato una stenosi
della neovagina (17,3%), che è stata risolta in 4 casi con un trattamento conservativo (incisione/dilatazione
chirurgica) mentre nei restanti 5 casi ha richiesto l’esecuzione di una vaginoplastica con ansa ileale sec.
Monti modifcata. Gli altri 11 pazienti (21,1%) hanno sviluppato una stenosi del meato uretrale esterno che
è stata risolta in tutti i casi tramite un intervento di meatoplastica. Le complicanze post-operatorie si sono
sviluppate in media dopo 7 mesi (range 3-14 mesi) dall’intervento di RCS. L’analisi statistica eseguita ha
evidenziato una riduzione significativa dell’insorgenza delle complicanze post-operatorie a partire dall’anno
2011 (p
Discussione
Il nostro studio dimostra come la chirurgia per la rassegnazione dei caratteri sessuali sia caratterizzata da
precoci complicanze post-operatorie. Questo risultato suggerisce di instaurare un più stretto follow-up
durante il primo anno dopo l’intervento chirurgico così da prevenirle. Lo studio dimostra inoltre come si
assista ad una progressiva riduzione delle complicanze chirurgiche postoperatorie considerando l’anno di
esecuzione della procedura. La significatività della riduzione delle complicanze si evidenzia a partire dal
2011 e puo’ essere motivata dal miglioramento della tecnica chirurgica, da un miglioramento della gestione
postoperatoria e da un più attento follow up dei pazienti. In conclusione gli interventi di RCS MtoF risultano
essere complessi e gravati da un alto rischio di complicanze post-operatorie.
Conclusioni
L’esperienza dell’equipe chirurgica, il miglioramento della tecnica chirurgica e l’organizzazione di un
follow-up post-operatorio strutturato sembrano avere un forte impatto nella riduzione di tali complicanze.
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A. Zucchi, M. Di Biase, T. Villirillo, L. Lepri, C. Porrozzi, H. Nikaj, E. Costantini (PErugia)
Scopo del lavoro
Scopo di questo lavoro retrospettivo è quello di valutare, come endpoint primario, l’efficacia in termini
funzionali della corporoplastica con innesto di patch di mucosa buccale facendo riferimento alla rapidità
di ripresa delle erezioni spontanee dopo chirurgia e alle complicanze nel postoperatorio. Come endpoint
secondario è stato valutato il grado di soddisfazione personale dei pazienti e delle partners
Materiali e metodi
Sono stati selezionati pazienti sottoposti a corporoplastica con patch di mucosa buccale tra il 2006 e il 2013
con diagnosi di malattia di La Peyronie (IPP) stabilizzata da più di 6 mesi e con erezioni valide valutate con
IIEF pre-operatorio. Sono stati esclusi i pazienti già sottoposti ad un qualsiasi tipo di chirurgia peniena. I
controlli di follow up sono stati eseguiti con cadenza trimestrale con compilazione dei questionari IIEF-5
e PGI-I a un anno dall’intervento. E’ stato infine valutato il grado di soddisfazione della partner mediante
questionario a 4 voci. Analisi statistica: test di Wilcoxon per comparare i dati dei pazienti e coefficiente di
correlazione rho di Spearman per valutare le correlazioni tra le variabili
Risultati
Sono stati valutati 30 pazienti con età media di 55 anni ed un follow up medio di 43 mesi. Due pazienti sono
stati persi durante il follow-up. Non è stata rilevata alcuna complicanze al di sopra del grado 1 della ClavienDindo scale. E’ stato riscontrato solo 1 caso di recurvatum recidivo di media entità a distanza di 1 anno.
Tutti i pazienti hanno riferito erezioni spontanee dopo una media di 3,8 giorni dall’intervento e nessuno ha
necessitato di terapia riabilitativa con vacuum device. Non è stata riscontrata alcuna correlazione statistica
significativa tra il grado del recurvatum e i valori di IIEF preoperatorio (p=0.145), mentre è stato evidenziato
un miglioramento dell’IIEF a distanza di un anno in correlazione al valore preoperatorio (p=0.031). L’analisi
del PGI-I questionnarie ha evidenziato un grado di soddisfazione elevato da parte del paziente con il 67,8%
di risposta variabile tra il “davvero molto migliorato” e “molto migliorato”. Per quanto riguarda infine la
soddisfazione delle partner 25/28 si sono dichiarate “molto soddisfatte”
Discussione
A prescindere dal tipo di incisione eseguita la scelta del patch può variare in base alle esperienze personali
del chirurgo. In ogni caso la ricerca è sostanzialmente indirizzata a trovare materiali che diano la minor
reazione cicatriziale, causa spesso di recurvatum recidivo e di discomfort postoperatorio. I dati della
letteratura a tal proposito sono estremamente variabili e spesso il grado di soddisfazione del paziente non
risulta essere disponibile
Conclusioni
I risultati positivi ottenuti in termini di soddisfazione personale e della partner ed il ridottissimo costo dovuto
all’utilizzo di materiale esclusivamente autologo, con caratteristiche peculiari più valide rispetto ad altri
patch, rendono tale metodica una valida alternativa nel trattamento della IPP associata a recurvatum
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PROPOSTA TERAPEUTICA PER IL TRATTAMENTO DEL PRIAPISMO INVETERATO
SODDISFAZIONE A LUNGO TERMINE DOPO CHIRURGIA PROTESICA SEMPLICE E
PROCEDURE COMPLESSE DI CHIRURGIA DI PLACCA PER INDURATIO PENIS PLASTICA
M. Grasso, S. Blanco, M. Castelli, A. Grasso (Monza)
Scopo del lavoro
Il priapismo costituisce una emergenza urologica che necessita di un trattamento immediato perchè possa
essere garantita l’efficacia del risultato terapeutico. Lo scopo delle cure è il ripristino dello stato di flaccidità
del pene con la successiva ripresa della funzione erettile. La storia naturale del priapismo ischemico
della durata superiore alle 48 ore (priapismo inveterato) è la fibrosi dei corpi cavernosi con conseguente
deficit erettile, come descritto in letteratura, che potrà essere curato in modo definitivo solo con l’impianto
protesico. Attualmente non vi è una terapia standardizzata per la cura del priapismo inveterato. Questa
condizione deve a nostro avviso essere considerata essenzialmente come una trombosi dei corpi cavernosi.
Proponiamo il trattamento che utilizziamo da anni con successo nel trattamento del priapismo non
rispondente a terapie di prima linea e che si è dimostrato efficace anche in casi insorti da oltre 48 ore.
Materiali e metodi
Abbiamo valutato 7 pazienti giunti al nostro ospedale negli ultimi 5 anni per priapismo inveterato non
responsivi alle terapie standard di prima linea. In 5 pazienti non erano presenti fattori di rischio noti, in un
caso era in corso terapia con neurolettici, in un secondo caso il paziente aveva assunto cocaina. Dopo aver
posizionato un ago-cannula trans glandulare e somministrato un bolo di 5000U di eparina, abbiamo quindi
somministrato dallo stesso accesso 10000U di eparina diluite in 250cc di fisiologica alla velocità di 10ml/h
in 24 ore, ripetuto per due giorni consecutivi. Successivamente è stata instaurata una terapia con eparinoide
sottocutaneo per 30 giorni.
Risultati
Il trattamento è stato ben tollerato da tutti i pazienti. In tutti i pazienti si è verificata detumescenza entro 48
ore dall’inizio del trattamento. I pazienti sono stati sottoposti a controllo clinico ad 1 e 12 mesi: in tutti i casi
entro un mese dal trattamento vi è stata una ripresa dell’attività erettiva. In nessun paziente è stato necessario
eseguire uno shunt chirurgico o posizionare protesi peniene.
Discussione
Ad oggi in letteratura non è presente la descrizione di un trattamento efficace del priapismo inveterato
ed è considerata come inevitabile l’evoluzione in deficit erettile. Il trattamento da noi proposto, basato su
studi di fisiopatologia del priapismo e sui concetti utilizzati nella terapia delle flebotrombosi, ha dimostrato
di essere efficace anche in pazienti in cui la comunità scientifica considera inevitabile l’evoluzione in
impotenza erigendi. E’ nostra convinzione, confermata dai risultati, che, indipendentemente dal processo
eziopatogenetico che innesca il priapismo, la persistenza del medesimo sia da attribuire ad una estesa
trombosi dei corpi cavernosi.
Conclusioni
Il priapismo “stabilizzato” da molte ore dovrebbe essere trattato con il nostro schema terapeutico prima di
programmare trattamenti chirurgici invasivi che esitano inevitabilmente in deficit funzionale.
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C. Ceruti, L. Rolle, O. Sedigh, T. Massimiliano, M. Preto, M. Falcone, V. Comisso, B. Frea (Torino)
Scopo del lavoro
I pazienti affetti da Induratio Penis Plastica (IPP) con disfunzione erettile e incurvamento o accorciamento
penieno possono essere trattati, a seconda della gravita del quadro, con il posizionamento di protesi con
modelling oppure con interventi più complessi di chirurgia di placca su protesi. Scopo del lavoro è valutare
risultati e soddisfazione a lungo termine dei pazienti sottoposti a chirurgia, in particolare complessa, per IPP,
argomento sul quale sono disponibili pochissimi dati in letteratura.
Materiali e metodi
Abbiamo analizzato i dati dei pazienti sottoposti a chirurgia protesica per IPP dal 2010 al 2012. Sono
disponibili dati completi di 33 pazienti: 9 sono stati sottoposti a impianto protesico con modelling (gruppo
A), 24 a chirurgia di placca complessa su protesi: incisione standard ad H o incisione circonferenziale
con “sliding technique” (JSM 2012, 9 (9), 2389-95). Sono state impiantate protesi AMS 700 in 14 casi,
malleabili o AMS Spectra in 9 casi, Virilis in 10 casi. Per confezionare il patch è stato usato SIS in 14 casi,
tunica vaginale autologa in 6 e Tachosil in 4. I pazienti sono stati valutati prima della chirurgia e a 12 mesi
con IIEF, SEP e Peyronie’s Disease Questionnaire - PDQ (J Urol 2013, 190 (2): 627-34); a 12 mesi con
visita, EDITS e domande “ad hoc”. Statistica: T test, chi-square test.
Risultati
4 pazienti (1 del gruppo A, 3 del gruppo B) hanno riportato complicanze Clavien I; 1 paziente (gruppo A)
è stato sottoposto a revisione chirurgica per cedimento apicale a 1 anno. Nessun paziente ha dimostrato
incurvamento recidivo. L’IIEF medio è salito da 41.5 a 58.2 a 12 mesi (gruppo A da 43 a 62, gruppo
B da 35 a 58, p=0.28); in entrambi i gruppi i punteggi medi di tutti i 3 domini del PDQ sono diminuiti
significativamente dopo l’intervento (rispettivamente per i tre domini da 14 a 2.3, da 7.9 a 0.7, da 8.4 a 2.4);
confrontando i due gruppi, si registra nel dominio 1 un miglioramento significativamente maggiore nel
gruppo B (p
Discussione
In entrambi i gruppi si registrano miglioramenti significativi in tutti i parametri funzionali e di soddisfazione.
Le variazioni non presentano differenze significative tra i due gruppi tranne che per il primo dominio del
PDQ, focalizzato sui sintomi di malattia, che migliorano maggiormente nel gruppo B dove sono presenti i
casi più gravi.
Conclusioni
La chirurgia per IPP ha poche complicanze, buoni risultati e una alta soddisfazione generale a distanza.
Anche le procedure più complesse, nonostante la maggior invasività, presentano risultati funzionali e di
soddisfazione paragonabili a quelle dei casi meno severi.
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STANDARDIZZAZIONE DELLE TECNICHE DI REPORT E GRADING DELLE COMPLICANZE
IN CHIRURGIA PROTESICA : CREAZIONE DI UN MODELLO UNIVOCO DI VALUTAZIONE
DELLE COMPLICANZE LEGATE ALLE PROCEDURE DI IMPLANTOLOGIA NELLA
CHIRURGIA ANDROLOGICA
Extraperitoneal laparoscopic renal enucleation with renal
hypotension on demand: oncologic and functional results of 100 cases
L. Pucci, M. Capece, G. Grimaldi, G. Battaglia, R. Riccio, P. Fedelini, M. Carrino (Napoli)
Aim:
to evaluate feasibility and safety of Extraperitoneal Laparoscopic Renal Enucleation (ELRE) with renal
hypotension on demand and to report the oncologic and functional results at 20 months follow-up.
Scopo del lavoro
L’accurata valutazione della gravità delle complicanze e la possibilità di un loro preciso ed omogeneo report
rappresenta un irrinunciabile indicatore di qualità delle procedure chirurgiche. Nel nostro studio abbiamo
rivalutato le complicanze di impianti protesi secondo la classificazione Clavien-Dindo (versione rivisitata e
validata) identificando per ciascuna la corretta attribuzione alla classe di gravità.
Materials and Methods:
from June 2010 to June 2013, we performed 100 ELRE with controlled renal hypotension on demand for
cT1 renal masses. All patients were evaluated prospectively through Karnofsky performance status scale,
R.E.N.A.L. Nephrometry Score e Clavien-Dindo. The renal function was assessed measuring serum
creatinina and eGFR preoperatively and 3,5,7, 90 days after surgery.
Materiali e metodi
Sono state riviste 60 procedure di impianto eseguite dal 2006 al 2010 da un solo operatore e con
identica tecnica riconsiderando le complicanze secondo la classificazione di Clavien-Dindo applicata
alla chirurgia protesica. Il sistema di riclassificazione è stato eseguito secondo la procedura indicata
da Mitropulos et coll: definizione delle complicanze ed assegnazione ad una classe di gravità;
descrizione del metodo di raccolta dati (prospettico- retrospettivo) e qualifica del data menager (medicoparamedico- altri) indicando se ha partecipato alla sperimentazione; durata del follow up; distinzione
delle complicanze correlate alla procedura o da essa indipendenti; segnalazione della incidenza statistica
dei “persi al follow up”. Le complicanze identificate sono state assegnate ad una specifica classe di
Clavien- Dindo secondo i seguenti criteri: CLASSE I = Intenso dolore post-operatorio, Infezioni
cutanee superficiali (Adesepidermofria inguinale),disfunzioni psicologiche personali o relazionali
richiedenti counselling,psicosessuologico,ematoma superficiale.CLASSE II : Ematoma pelvico con Hb
6,5 (emotrasfusione)CLASSE III :infezione con rimozione dell’impianto,rigetto – rottura meccanica –
estrusione,effetto “Concorde”,ematoma grave (revisione chirurgica),dolore incontrollabile con terapia
medica,aneurisma dei cilindri, deformazione ad “S”. CLASSE IV : Ictus. CLASSE V = Non riscontrate
Results:
The mean value of Karnofsky index was 90%, the mean clinical size of the mass was 3,9 cm (range
1,5-8cm); the mean RENAL score was 7. The mean operative time was 110 min. (range 50-180). Renal
hypotension was carried out in 10 cases. Conversion to open surgery was never necessary. The mean
estimated blood loss was 204±150 ml. Positive surgical margins were 5%. The mean hospital stay was
5 days (range 3-10). The postoperative complications was 20%: 9/20 were grade I according to Clavien
Dindo classification, 8/20 were grade II (of these, 4 required blood transfusions), 1 case of urinary leakage
occurred and it was treated with ureteral stenting (grade IIIa); there were 2 significant postoperative
bleedings which required a re-intervention without performing radical nephrectomy (grade IIIb).
At 3 months follow-up a slight mean increase of serum creatinine occurred (+2,06%) with consequent slight
decrease of eGFR (-1,24%). At 20 months follow up, 2 local recurrences happened and, of these, 1 case had
showed positive surgical margin.
Risultati
Sono state osservanze nove complicanze di Classe I (4 ematomi superficiali, 2 infezioni cutanee, 1 dolore
intenso post-operatorio, 2 disfunzioni psicologiche), una complicanza di classe II (ematoma pelvico con
emotrasfusione); sei complicanze di classe III (1 rottura meccanica, 2 infezioni, 1 estrusione uretrale, 1
ematoma grave, 1 rimozione di protesi funzionante per dolore incontrollabile) una sola complicanza di
classe IV (Ictus in 7ª giornata in paziente iperteso), nessuna complicanza di classe V.
Discussione
La classificazione standardizzata delle tecniche di report e Grading delle complicanze in chirurgia è un
obiettivo di fondamentale importanza a cui tendono le più importanti società scientifiche, in particolare nella
chirurgia protesica ove risulta elevata l’incidenza e la possibilità di contenzioso.
Conclusioni
È auspicabile che altri centri aderiscano al nostro iniziale tentativo di standardizzazione allo scopo di
identificare sottoclassi di complicanze da meglio definire secondo lo schema proposto. Tutto ciò alfine di
formulare una standardizzazione da utilizzare di routine e proporre ad altre società scientifiche.
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Discussion:
Laparoscopic partial nephrectomy is the surgical treatment of T1 renal mass, ensuring
the advantages of minimally invasive techniques with lower peri-operative morbidity and similar oncologic
safety compared to open surgery. The extraperitoneal approach allows the immediate control of the renal
artery; this technique is particulary useful in patients previously undergone major abdominal surgery because
it avoids to violate the peritoneal cavity. In Literature, the oncologic safety of renal enucleation has been
proved being similar to enucleoresection; moreover, renal enucleation allows to decrease the intraoperative
bleeding because it takes advantage of avascular cleavage plane between the pseudo-capsule of the tumor
and the surrounding healthy tissue.
Furthermore, the controlled renal hypotension is achieved through the application of a vessel loop around
the renal artery, which is then put out parallel to the posterior trocar. This permits to decrease the renal
arterial flow on demand, avoiding however a real and complete renal ischemia.
Conclusion:
Our results demonstrate that ERLE with controlled renal hypotension is
a feasible and safe surgical treatment of cT1 renal mass.
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ANALYSIS OF CLINICAL PREDICTIVE FACTORS OF THE TRIFECTA OUTCOME AFTER
PARTIAL NEPHRECTOMY. AN AGILE STUDY
NEPHRON SPARING SURGERY DOES NOT ALWAYS DECREASE OTHER-CAUSES
MORTALITY RELATIVE TO RADICAL NEPHRECTOMY IN PATIENTS WITH NORMAL
PREOPERATIVE RENAL FUNCTION
A. Minervini, A. Antonelli, A. Celia, S. Crivellaro, D. Dente, V. Di Santo, B. Frea, A. Gritti, A. Morlacco, A.
Porreca, B. Rocco, P. Parma, C. Simeone, S. Zaramella, S. Serni, M. Carini, A. Minervini (Firenze)
Scopo del lavoro
The trifecta is an accepted index of the excellent surgical outcome after partial nephrectomy. Aim of this
study was to assess which clinical variables may be an independent predictors of the trifecta outcome in
patients candidates to partial nephrectomy.
Materiali e metodi
The data of 440 patients treated with open partial nephrectomy for T1 RCC were reviewed in our multicenter prospectively maintained database. Warm ischemia time (WIT)>25 min, complications, and
postoperative acute kidney dysfunction (AKD), separately. The perioperative clinical variables associated
with the Trifecta outcome, defined as warm ischemia time (WIT)
Risultati
The trifecta outcome was achieved in 315 (71.6%) patients; 7.5% of patients had WIT ≥ 25 min, 3.5% had
PSM and 21.2% had perioperative complications. Reoperation rate for Clavien≥3 complication was 6.7%.
On univariate analysis the trifecta was significantly associated with patients gender (p
Discussione
In our analysis the clarity of the surgical field, associated to the containment of intraoperative bleeding and
a favorable tumor nephrometry, resulted of critical importance for the achievement of the excellent surgical
outcome.
Conclusioni
I
U. Capitanio, C. Terrone, A. Antonelli, A. Minervini, A. Volpe, C. Fiori, F. Porpiglia, M. Furlan, R. Matloob,
F. Regis, E. Di Trapani, P. De Angeli, S. Serni, R. Colombo, M. Carini, C. Simeone, F. Montorsi, R. Bertini
(Milano)
Scopo del lavoro
Some reports suggested that nephron sparing surgery (NSS) may better protect against other-cause mortality
(OCM) when compared with radical nephrectomy (RN) in patients with small renal masses. However,
the majority of those studies could not adjust their results for potential selection bias secondary to clinical
baseline characteristics of patients. In the current study, we aimed to test the effect of treatment type (NSS
vs. RN) after accounting for clinical characteristics, comorbidities and individual cardiovascular risk.
Materiali e metodi
A multi-institutional collaboration among four European Tertiary Care Centers allowed collecting 2685
patients with a clinical T1a-T1b N0 M0 renal mass. Patients underwent RN (n=1059, 39.4%) or NSS
(n=1626, 60.6%) and showed normal estimated glomerular filtration rates (eGFR) before surgery (defined as
a pre-operative eGFR≥60 milliliters per minute per 1.73 m2). Descriptive, univariable and multivariable Cox
regression analyses were used to predict the risk of OCM. To adjust for inherent baseline differences among
patients, we included as covariates: age, clinical tumor size, gender, presence of hypertension at diagnosis,
baseline Charlson comorbidity index (CCI), body mass index and smoker status.
Risultati
Mean follow up period was 76 months (median 61). Mean patient age resulted 60 years (median 62). Mean
body mass index resulted 25 kg/m2. Overall, 37.2% and 9.4% of the patients had hypertension or diabetes,
respectively. CCI resulted 0-1 in 73.2% of the patients. The 5- and 10-yr OCM rates after nephrectomy
were 5.2% and 13.2% for NSS versus 7.4% and 15.1% for RN, respectively (p=0.3). At multivariable
analyses, patients who underwent PN showed similar risk to die for OCM compared with their RN-treated
counterparts (hazard ratio [HR]: 0.77; 95% confidence interval, 0.48-1.25; p=0.3). Increasing age (HR: 1.12,
p
Discussione
Controversies exist whether nephron sparing surgery (NSS) may better protect against other-cause mortality
(OCM) and renal function impairment (RFI) when compared with radical nephrectomy (RN) in the surgical
treatment of patients with kidney cancer. Such uncertainty derives from the apparent contrast between the
negative findings of the European Organization for Research and Treatment of Cancer (EORTC) randomized
trial 30904 demonstrating no benefit in performing NSS and the majority of retrospective studies showing,
conversely, an evident advantage in terms of overall survival and better postoperative renal function.
Conclusioni
After correcting for clinical characteristics, comorbidities and cardiovascular risk at diagnosis, NSS does not
decrease other-causes mortality relative to RN in patients with clinical T1a-T1b renal masses and a normal
kidney function before surgery.
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NEPHRON SPARING TECHNIQUES INDEPENDENTLY REDUCE THE RISK OF
CARDIOVASCULAR EVENTS AFTER SURGERY IN PATIENTS WITH A SMALL RENAL MASS
AND A NORMAL PREOPERATIVE RENAL FUNCTION
PARTIAL NEPHRECTOMY FOR PATIENTS WITH A SOLITARY KIDNEY: ONCOLOGICAL
AND FUNCTIONAL LONG TERM FOLLOW UP
R. Bertini, U. Capitanio, C. Terrone, A. Antonelli, A. Minervini, A. Volpe, C. Fiori, F. Porpiglia, M. Furlan,
R. Matloob, F. Regis, M. Zacchero, L. Masieri, E. Di Trapani, A. Salonia, M. Carini, C. Simeone, F.
Montorsi (Milan)
Scopo del lavoro
Some reports suggested that nephron sparing surgery (NSS) may protect against cardiovascular events (CE)
when compared with radical nephrectomy (RN) in patients with small renal masses. However, the majority
of those studies could not adjust their results for potential selection bias secondary to clinical baseline
cardiovascular risk of the patients. In the current study, we aimed to test the effect of treatment type (NSS
vs. RN) on prevalence of CE after accounting for clinical characteristics, comorbidities and individual
cardiovascular risk.
Materiali e metodi
patients with a clinical T1a-T1b N0 M0 renal mass and complete cardiovascular event follow-up data.
Patients underwent RN (n=462, 34.7%) or NSS (n=869, 65.3%) and showed normal estimated glomerular
filtration rates (eGFR) before surgery (defined as a pre-operative eGFR≥60 milliliters per minute per 1.73
m2). CE was defined as the onset of coronary artery disease, cardiomyopathy, hypertensive heart disease,
heart failure, cardiac dysrhythmias or cerebrovascular disease. Univariable and multivariable Cox regression
analyses predicting CE were performed. To adjust for inherent baseline differences among patients, we
relied on multivariable analyses adjusting for age, clinical tumor size, gender, presence of hypertension or
diabetes at diagnosis, baseline Charlson comorbidity index (CCI) and smoker status.
Risultati
Mean patient age resulted 60.6 years (median 62). Overall, 14.7% and 11% of the patients had uncontrolled
hypertension or diabetes, respectively. CCI resulted 0-1 in 70.8% of the patients. At a mean follow up period
of 71 months, 197 patients (14.8%) developed a CE. When stratifying for treatment type, 10.5 vs. 22.9%
patients developed CE (p
Discussione
The risk of cardiovascular event after renal surgery is not negligible. Patients treated with NSS have half of
the risk to develop CE relative to RN counterparts.
Conclusioni
Also after accounting for clinical characteristics, comorbidities and cardiovascular risk at diagnosis, NSS
independently decrease the risk of CE relative to RN.
M. Seveso, M. Seveso, L. Castaldo, G. Taverna, R. Hurle, G. Giusto, A. Benetti, L. Pasini, S. Zandegiacomo
De Zorzi, R. Peschechera, S. Proietti, P. Graziotti (Rozzano)
Scopo del lavoro
The most critical indication for partial nephrectomy remains a patient with a solitary kidney containing a
renal cortical tumour;preserving renal parenchyma is imperative and must be weighed against the risk of
compromising oncological efficacy.Partial nephrectomy(PN)is still a challenging technique and there have
been only a few reports from a limited number of institutions concerning PN for patients with a solitary
kidney that provide favourable outcomes for renal function and oncological control.
Materiali e metodi
Medical records of 483 consecutive patients who underwent OPN(369 pts)and LPN(114 pts)from January
1997 to June 2013 were retrospectively analyzed.Patients presenting with a solitary kidney were identified
and their outcomes assessed.A total of 63 patients with a solitary kidney were identified and included in
the analysis.Median preoperative radiologic tumour size was 4.1 cm along with a R.E.N.A.L.score of 6.All
of the tumors scored below 9 points according to the R.E.N.A.L Nephrometry score.Renal function was
measured by serum creatinine level on postoperative day 1,3,4,7,30,6 and 12 months.
Risultati
The median operative time was 121 min(121-243).No remarkable bleeding occurred during surgery.Mean
percent of parenchyma resected had been 30±20%.In 36 patients,the pathological examination revealed
renal cell carcinoma,in 12 papillary,8 chromofobe,7 oncocytoma.Negative surgical margins were achieved
in all patients.Post operative stage was characterized by 5 urinary fistulae treated by the placing of uretheral
stent,2 arterovenous fistulae appeared during the 5th and 15th post-operative day which were treated
with embolization.4 patients required blood transfusion due to anemia.Overall,21%of the patients didn’t
experience any increase of serum creatinine,while 41%experienced a significative worsening in serum
creatinine values.In 38%of the patients was recorded a not-significant worsening of serum creatinine.In
35%of the patients,a worsening of the renal function was recorded,with a increase greater than 50%with
respect to the pre-operative values.70%of these patients had a pre-operative serum creatinine grater than 1.5
mg/dl,a percentage of resected parenchyma of 40%and an average ischemic time >30 minutes.In the long
run follow up,95,5%of patients preserved a normal renal function.Our oncologic results in the long run were
consistent with what was reported in other studies.22%of patients 14 had a tumor recurrence with a 3.5%of
local recurrence,12%metastases,6,5%both local and distant masses.8 patients died:5 for renal tumor,2 for
cardiovascular problems and 1 for unknown cause.
Discussione
Nephron sparing surgery is an absolute indication in patients with a solitary kidney or renal deterioration.
The procedure results safe with low complication rate.After an initial decrease of renal function,it stabilizes
in the first post-operative year.
Conclusioni
The results in the long run show also the validity of the procedure with great oncological results.
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PREDICTIVE FACTORS OF SURGICAL COMPLICATION, ISCHEMIA TIME AND TRIFECTA
OUTCOME IN CT1B RENAL MASSES. REPORT OF A MULTICENTRIC INTERNATIONAL
PROSPECTIVE STUDY
RENAL FUNCTION IMPAIRMENT AFTER NEPHRON SPARING SURGERY OR
RADICAL NEPHRECTOMY IN PATIENTS WITH A SMALL RENAL MASS AND NORMAL
PREOPERATIVE RENAL FUNCTION
F. Porpiglia, A. Minervini, R. Bertolo, S. Bhayani , A. Mari, C. Fiori, G. Guazzoni, N. Longo, V. Mirone, G.
Morgia, A. Mottrie, J. Porter, S. Serni, V. Ficarra, M. Carini (Orbassano)
U. Capitanio, C. Terrone, A. Antonelli, A. Minervini, C. Fiori, F. Porpiglia, A. Volpe, F. Castiglione,
M. Furlan, F. Regis, L. Zegna, G. Vittori, E. Di Trapani, M. Carini, C. Simeone, F. Montorsi, R. Bertini
(Milano)
Scopo del lavoro
This study reports a multicentre international prospective dataset of NSS performed in cT1b renal tumors.
The aim of this study is to compare different approaches in NSS of cT1b renal masses and to analyse
predictive factors of surgical complications and trifecta outcomes.
Materiali e metodi
In this series 262 cases performed in 23 centres were prospectively analysed. Patients were treated in low
and high volume centres (defined as < or ≥ 50 per year NSS). Trifecta was defined as simultaneous ischemia
Risultati
A median clinical tumor diameter of 5 (4.4-5.5) cm was reported. 36.6% lesions presented a 25 min ischemia
time. Surgical complications were 17.9%, surgical Clavien 2 and 3 were 9.2% and 5.0%, respectively.
Positive surgical margin were registered 6.9% of patients. Trifecta was achieved 58% patients. Open
approach was performed in 37.8% of cases, video laparoscopic approach (VLP) in 21.8% of cases and
robotic approach (RAPN) in 40.4% of cases. Three groups presented similar preoperative features. Open,
VLP, and RAPN were performed in high-volume centres in 61.6%, 93.0% and 100% of cases, respectively,
p=0.001. Three groups presented significant difference in ischemia time values (16 (14-20) vs 24 (20-28)
vs 22 (18-27) mins, respectively. P=0,01). A significant difference in medical complications was found
between three groups (13.1% vs 1.8% vs 1.9%. p>0,001). No significant difference was found between
three groups in overall, clavien 2 and 3 surgical complications, positive surgical margins, preoperative-3rd
day delta haemoglobin and eGFR. At uni and multivariate analysis mediorenal location (OR 2.90, p 0.001)
and estimated blood loss (EBL) (OR 1.0, p 0.001) were predictive factors of overall surgical complication.
At univariate analysis, significant factors for trifecta negative outcome were endophytical growth pattern
(p=0.04) and high EBL (p
Discussione
NSS seems a feasible technique for cT1b renal masses, but it still presents a high rate of surgical
complications. A minimally invasive (both VLP and robot assisted) approach can be used in experienced
centres, without risk of complication and low term renal function impairment. High bleeding during the
procedure and mediorenal lesions are predictive factors of surgical complications. High bleeding and
endophytical lesion are predictive factors of trifecta negative outcome.
Scopo del lavoro
Some reports suggested that nephron sparing surgery (NSS) may protect against renal function impairment
(RFI) when compared with radical nephrectomy (RN) in patients with small renal masses. In the current
study, we aimed to test the effect of treatment type (NSS vs. RN) on prevalence of RFI and renal endstage kidney disease (ESRD) after accounting for clinical characteristics, comorbidities and individual
cardiovascular risk.
Materiali e metodi
patients with a clinical T1a-T1b N0 M0 renal mass and complete functional follow-up data. Patients
underwent RN (n=765, 37.8%) or NSS (n=1259, 62.2%) and showed normal estimated glomerular filtration
rates (eGFR) before surgery (defined as a pre-operative eGFR≥60 milliliters per minute per 1.73 m2).
Descriptive, univariable and multivariable Cox regression analyses predicting RFI were performed. To
adjust for inherent baseline differences among patients, we included as covariates: preoperative creatinine,
age, clinical tumor size, gender, presence of hypertension or diabetes at diagnosis, baseline Charlson
comorbidity index (CCI), body mass index and smoker status.
Risultati
Mean patient age resulted 60.6 years (median 62). Mean body mass index resulted 26 kg/m2. Overall, 20.0%
and 9.9% of the patients had uncontrolled hypertension or diabetes, respectively. CCI resulted 0-1 in 71.9%
of the patients. At a mean follow up period of 68.2 months, 81.1% vs. 55.8% patients showed normal renal
function after NSS vs. RN, respectively (p
Discussione
Although the risk of severe renal function impairment and ESRD is negligible, up to 30% of the patients
with clinical T1a-T1b renal masses and a normal preoperative kidney function harbour mild RFI after
surgery.
Conclusioni
Also after accounting for clinical characteristics, comorbidities and cardiovascular risk at diagnosis, NSS
significantly decrease the risk of RFI relative to RN.
Conclusioni
This paper has the worship of a simultaneous comparison of outcomes in different approaches in NSS in
cT1b renal masses.
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ROBOT-ASSISTED VERSUS OPEN PARTIAL NEPHRECTOMY. A MATCHED-PAIR ANALYSIS
OF AN INTERNATIONAL MULTICENTER SERIES
ROBOT-ASSISTED PARTIAL NEPHRECTOMY FOR RENAL TUMORS WITH RENAL
NEPHROMETRY SCORE >=10: PERIOPERATIVE OUTCOMES FROM A LARGE
MULTICENTRE INTERNATIONAL DATASET (VATTIKUTI GLOBAL QUALITY INITIATIVE
ON ROBOTIC UROLOGIC SURGERY)
V. Ficarra, A. Minervini, A. Antonelli, S. Bhayani, G. Guazzoni, N. Longo, G. Martorana, G. Morgia, A.
Mottrie, J. Porter, C. Simeone, G. Vittori, F. Zattoni, M. Carini (Udine)
Aim of the study
Only few studies compared the results of the gold standard treatment of cT1 renal cell carcinoma (RCC),
with the standard mini-invasive alternative, providing conflicting results. Our aim was to compare the
perioperative, pathological and functional outcomes in a large multicenter series of patients who underwent
open partial nephrectomy (OPN) or robot-assisted partial nephrectomy (RAPN) for suspected renal tumors.
This was a retrospective, multicenter, international, matched-pair analysis comparing patients who
underwent RAPN or OPN for suspected renal cell carcinoma (RCC), extracted from the preliminary analysis
of the REgistry of COnservative Renal surgery database (RECORd Project) that collected data from 19
different centres (368 patients), promoted by the ‘Leading Urological No profit foundation Advanced
research’ (LUNA) of the Italian Society of Urology (SIU) and from a multicentre, international database
collecting cases treated in four high-volume referral centres of robotic surgery (415 patients). The propensity
score was calculated for each patient using multivariable logistic regression based upon the following
covariates: age, clinical tumor size, longitudinal location (upper or inferior poles vs middle pole) and tumor
exophytic rate (< 50% exophytic vs others). The matching was in a 1:1 ratio for the surgical approach and
included 200 patients in each arm.
Results
The mean warm ischemia time (WIT) was shorter in the OPN group than in the RAPN group (15.4 ± 5.9 vs
19.2 ± 7.3 min; P < 0.001). Conversely, the median (interquartile range, IQR) estimated blood loss (EBL)
was 150 (100-300) mL in the OPN group and 100 (50-150) mL in the RAPN group (P < 0.001). There were
no differences in operative time (p=0.18) and the intraoperative complication rate (p=0.31) between the
approaches. Postoperative complications were recorded in 43 (21.5%) patients who underwent OPN and in
28 (14%) who received RAPN (p=0.02). Moreover, major complications (grade 3-4) were reported in nine
(4.5%) patients after OPN and in nine (4.5%) after RAPN. Positive margins were detected in nine (5.5%)
patients after OPN and in nine (5.7%) after RAPN (p=0.98). The mean +/-SD 3-month estimated glomerular
filtration rate declined by 16.6 ±18.1 ml/min from preoperative value in the OPN group and by 16.4 ± 22.9
ml/min in the RAPN group (p=0.28).
Discussion
RAPN can achieve equivalent perioperative, early oncological and functional outcomes as OPN. Moreover,
RAPN is a less invasive approach, offering a lower risk of bleeding and postoperative complications than
OPN.
C. Rogers, A. Volpe, A. Mottrie, R. Ahlawat, S. Rawal, D. Moon, F. Porpiglia, N. Buffi, B. Challacombe, V.
Ficarra, M. Bhandari, R. Abaza (Detroit, Michigan (USA))
Aim of the study
Robot-assisted partial nephrectomy (RAPN) has been shown to be a safe and effective minimally invasive
treatment for small renal tumors. Anatomical classification systems have been developed to better define the
surgical challenge of renal tumors and predict the risk of complications, longer warm ischemia times (WIT)
and positive surgical margins (PSMs). At present, limited data from small and mainly single-institutional
series are available on the outcomes of RAPN for renal tumors with very high surgical challenge.
81 patients who underwent RAPN between October 2006 and July 2013 for a renal tumor with a RENAL
nephrometry score ≥10 were identified from a multi-institutional retrospective database including 1011
cases of RAPN from 9 tertiary robotic centres in Europe, North America, India and Australia. Intraoperative
outcomes, pathological outcomes and complications were assessed. Complications were graded according to
the Clavien-Dindo classification system.
Results
Median age of patients was 56 years and the average Charlson comorbidity score was 2 (IQR 0-3). Median
tumor size was 45 mm (IQR 33-55, range 21-110). The tumors were cT1a, cT1b and cT2 in 28 (34.6%), 43
(53.1%) and 10 cases (12.3%), respectively. Sixty masses (74%) had a RENAL score 10, 19 (23.5%) had
a RENAL score 11 and 2 (2.5%) had a RENAL score 12. Median operative time was 220 minutes (IQR
152-259). Median estimated blood loss and WIT were 100 ml (IQR 100-250) and 22 minutes (IQR 16-28),
respectively. Five intraoperative complications occurred (6.2%). Postoperative complications were observed
in 15 cases (18.5%) and 6 (7.4%) were Clavien grade ≥3. Hospital stay was on average 3 days (IQR 1-5).
A benign pathology was found in 10 cases (12.3%). Six tumors (7.4%) were pT3a at final pathology and
positive surgical margins were detected in 2 cases (2.5%).
Discussion
nn
Conclusions
RAPN for renal tumors with a RENAL score ≥10 is feasible with limited blood loss and an acceptable
complication and positive surgical margin rate in centres with advanced robotic expertise. A longer than
typical operative time and WIT are due to the high surgical challenge of these lesions.
Conclusions
I
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Evaluation of kidney injury following clampless and clamped laparoscopic partial nephrectomy: can Neutrophil gelatinase-associated lipocain (NGAL) be helpful?
Porpiglia Francesco, Amparore Daniele, Aroasio Emiliano, Cossu Marco, Ragni Francesca, Cattaneo Giovanni, Di Stasio Andrea, Garrou Diletta, Scarpa Roberto Mario, Fiori Cristian.
Division of Urology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, (TO)
Division of clinical and biological sciences, University of Turin, San Luigi Gonzaga Hospital, Orbassano,
(TO)
OBJECTIVES:
NGAL (Neutrophil gelatinase-associated lipocain), a protein overexpressed in case of renal injury and dosable in both plasma and urine, is being discussing as a precocious biomarker of acute kidney injury.
The aim of this study was the evaluation of role of urinary-NGAL as marker to detect and quantify renal injury in patients who underwent clampless or clamped Laparoscopic Partial Nephrectomy (LPN).
PATIENT AND METHODS:
Seventy-five consecutive patients who underwent LPN between 3/2012 and 7/2013 were involved in this
study. Patients were divided into two groups according to the surgical technique used: Group A-37pts treated
with clampless-LPN (cl-LPN) and Group B-38pts treated with “clamped” (c-LPN). NGAL urinary values
were dosed on urine samples collected preoperatively and 24hours, 5 days, 3 months after surgery by ELISA
in all patients. Serum Creatinine (SCr) and GFR were determined at the same time points. Differences between the groups and within each group at different time points were tested, p-values<0.05 were considered
significant.
RESULTS:
The two groups resulted comparable in terms of demographic, preoperative and pathological data. Mean SCr
and GFR values were not different between group A and B and were stable at every time point. NGAL values were 29.3 ng/ml, 32.8 ng/ml, 73.6 ng/ml, 31.5 ng/ml in goup A and 26.5 ng/ml, 70.2 ng/ml, 87.8 ng/ml,
32.0 ng/ml in group B, respectively at baseline, 24 hours, 5 days and 3 months after surgery. Analyzing each
group, a statistically significant increase of NGAL values was found from baseline to 24 hours in Group B
(p=0.03) while, in Group A, no significant increase was found until 5 day after surgery (<0.01). For both
groups no differences were found when specifically testing NGAL
baseline versus 3rdmonth value (Group A; p=0.85, Group B; P=0.12). When comparing differences between
the Groups A and B in terms of NGAL values, the only significant difference was observed 24 hours after
surgery (p=0.04).
SIMPLE ENUCLEATION FOR THE TREATMENT OF HIGHLY COMPLEX RENAL TUMORS:
PERIOPERATIVE, FUNCTIONAL AND ONCOLOGICAL RESULTS.
G. Vittori, A. Mari, J. Frizzi, R. Fantechi, T. Chini, P. Della Camera, A. Chindemi, L. Masieri, M. Gacci, S.
Serni, M. Carini, A. Minervini (Florence)
Aim of the study
to assess perioperative, functional and oncological results of simple enucleation (SE) in patients with RCC
with 10-13 PADUA score, and to evaluate differences in perioperative results between open and robotic SE.
The data of 510 patients treated with SE between July 2006 and August 2013 in our department for RCC
were gathered in a prospectively maintained database. Of these, 96 had RCC with PADUA 10-13 (high
risk nephrometry tumors) and were selected for this study, including 76 treated open and 20 with robotic
SE (endoscopic robotic-assisted simple enucleation: ERASE). Conventional perioperative variables were
collected and compared between open and robotic approach with univariate analysis. Survival status and
functional data were gathered at follow-up. The probability of survival was estimated by the Kaplan-Meier
method.
Results
The mean tumor diameter was 4.8 cm, the PADUA score resulted 10, 11, 12 and 13 in 57.3%, 29.2%,
11.5%, and 2.1% of tumors, respectively. Overall, 19.8% of patients had stage≥3 chronic kidney disease
(CKD) and the 17.7% an imperative/relative indication. Clamping of renal pedicle was used for almost all
patients(99%), with a mean WIT of 19,2 ± 5,7 minutes. Average operative time was 126 minutes, mean EBL
was about 200 cc, and median(IQR) LOS was 6(5-7) days. The percentage of patients with postoperative
complications was 26.1% (2.1% Clavien 1, 14.6% Clavien 2, 8.3% Clavien 3, 1% Clavien 4). Benign tumors
accounted for 12.5% of patients. PSM rate was 3.6% (3/84). The trifecta outcome was accomplished in
56.2% of patients. In the robotic group the mean operative time resulted significantly longer (175 vs.113
min, p
Discussion
The application of SE in tumors with adverse nephrometry seems particularly appropriate, in order to reduce
the underuse of nephron sparing surgery in these clinical settings.
Conclusions
SE in highly complex renal masses is feasible, safe, and has satisfactory oncological results with a good
preservation of the overall renal function.
DISCUSSION:
We observed a progressive increase of urinary NGAL values from baseline until the fifth post-operative day
and a return to basal values at 3rd month. c-LPN Group, compared with cl-LPN Group, showed a steeper
and higher increase of NGAL values in the early postoperative period. Conversely, SCr and GFR values remained stable in all measurements.
CONCLUSIONS:
These data suggest that NGAL could be a useful molecular marker to evaluate the trend of acute kidney
damage, increasing precociously and strongly in case of renal ischemia.
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DIFFERENT PATTERN OF PELVIC URETERAL ENDOMETRIOSIS. WHAT IS THE BEST
TREATMENT? RESULTS OF A RETROSPECTIVE ANALYSIS
EFFICACY AND SAFETY OF ALFA1-BLOCKERS FOR THE TREATMENT OF RECURRENT
URINARY TRACT INFECTIONS IN WOMEN WITH DYSFUNCTIONAL VOIDING: A
PROSPECTIVE STUDY.
S. Butticè, G. Mucciardi, A. Galì, R. Pappalardo, A. Inferrera, E. Subba, C. Magno (Messina)
Scopo del lavoro
Endometriosis is a disease, characterized by the ectopic presence and growth of functional endometrial
tissue, glands and stroma, outside the uterine cavity . The ureter is the second most common site among
Urinary Tract Endometriosis (UTE). To date, Ureteral Endometriosis (UE) incidence is progressively
increasing in case series, because of improvement in diagnostic procedures . In most of cases, the UE
is asymptomatic and the diagnosis is often incidental. However, the late diagnosis and treatment of this
condition may lead to the silent loss of renal function. We treated both intrinsic (always obstructive) and
extrinsic subset of UE, subdividing the latter according to the presence or absence of obstructive pattern .
The aim of the current paper is to verify the best surgical procedure for each pattern of UE.
Materiali e metodi
We performed a retrospective analysis of our data, collected from March 2002 to August 2013. We treated
31 patients, 5 with intrinsic and 26 with extrinsic UE. Furthermore, cases of extrinsic UE were divided in
in two subsets: with (n=20) and without (n=6) obstructive pattern. In the obstructive subset we performed
ureteral stenting, resection and reimplantation (Lich-Gregoire technique); moreover in 3 of the 20 patients,
because of the extension of the mass (>2,5 cm), we had to perform also a Boari flap to obtain a tension-free
anastomosis. In the cases without obstructive pattern, we performed laparoscopic ureterolysis (shaving).
In the intrinsic subset, we performed endoureterotomy with 120-W 2-μm continuous-wave Tm:YAG laser
(Revolix 2). As follow-up, we performed ultrasound after one week, URO-TC, blood test and urine test after
one month and after six months.
Risultati
In the extrinsic subset of UE, we obtained a complete therapeutic success (100 %). Conversely, in the
intrinsic subset there was a recurrence of the disease, in fact in 3 patient persisted hydronephrosis (60%) of
first degree and 1 of these had associated hematuria (20%).
Discussione
Despite our study is limited by the little number of patients and the small period of follow-up , we can
suggest that in the extrinsic UE subset without obstructive pattern, ureterolysis is an appropriate treatment.
In the extrinsic UE with obstructive subset, the resection and reimplantation allows excellent results. In the
intrinsic subset, the endoureterotomy approach seems to be inadequate. For these reasons, we suggest to use
resection and reimplantation technique also for intrinsic pattern of UE, avoiding the undertreatment of this
condition which may cause loss of renal function and high rate of recurrence.
Conclusioni
endometriosis is a multi foci pathology that strikes different organs, the correct approach to this disease is
a straight cooperation between urologist and gynaecologist to improve the quality of life of the patients.
Further evaluations with a more consistent number of patients and with longer follow-up are still needed
before solid conclusions can be drawn
D. Minardi, F. Pellegrinelli, A. Conti, D. Fontana, M. Mattia, G. Milanese, G. Muzzonigro (Ancona)
Aim of the study
to evaluate the therapeutic effects of tamsulosin on urodynamic and voiding parameters in women with
dysfunctional voiding
103 women with recurrent UTIs and dysfunctional voiding were included and randomly assigned to receive
uroflowmetry biofeedback, α1-AR antagonists, uroflowmetry biofeedback combined to α1-AR antagonists,
no treatment. Patients were evaluated by AUASI at month 3 and 6 after study beginning and at year 1;
urodynamic investigation was performed in patients of group 1, 2 and 3 at month 3 and 6 after study
beginning and at 1 year, and in patients of group 4 at 12 months. All of the patients were followed up for 1
year with monthly urine cultures.
Results
Of the 155 patient initially enrolled, 128 women were finally evaluated; 35 were included in group 1, 38
in group 2, 37 in group 3 and 18 in group 4. At enrolment, storage symptoms were recorded respectively
in 27 patients of group 1, 27 of group 2, 29 of group 3, and 11 of group 4; emptying symptoms were
observed respectively in 27 patients of group 1, 24 of group 2, 25 of group 3, and in 11 of group 4. The
incidence of storage and emptying symptoms decreased significantly at 3, 6 and 12 months after treatment
in all the three treated groups, and remained stable during the study period; this was not observed in the
untreated patients. Mean flow rate, flow time, voiding volume increased significantly in all the three treated
groups (with a better outcome in patients of group 3), while post-void residual urine decreased; the results
remained stable up to 12 months; mean opening detrusor pressure and detrusor pressure at maximum flow
decreased significantly after treatment in all the three groups (with a better outcome in patients of group 3)
and remained stable during the follow-up, while they did not change significantly in the untreated patients;
by the analysis of mean urethral closure pressure and maximum urethral closure pressure we could observe
that they decreased significantly after treatment in the treated groups, but not in the untreated patients;
but in group 3, the decrease is significantly higher than for patients of groups 1 and 2. The prevalence of
UTI decreased significantly in all groups after treatment, and the results remained stable in the follow-up;
there were no significant differences between UTI success rates in the three groups; the prevalence of UTI
remained unchanged in the untreated group. At month 24 after study beginning, by AUASI it was possible
to observe that storage and emptying symptoms and voiding patterns were similar to the baseline values in
45% of patients. The incidence of UTIs was similar to baseline values in 35% of patients of groups 1, 2 and
3.
Discussion
Pelvic-floor therapy seems to be a reasonable component in the treatment of recurrent UTIs in which
dysfunctional voiding plays a role.
Conclusions
Tamsulosin associated to uroflowmetry biofeedback may be an effective and safe treatment option for
improving urinary symptoms and quality of life
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INTERIM ANALYSIS OF THE LONG-TERM EFFICACY AND SAFETY OF REPEAT
ONABOTULINUMTOXINA IN THE TREATMENT OF OVERACTIVE BLADDER AND
URINARY INCONTINENCE, MEDIAN 2.4 YEARS’ FOLLOW UP
Percutaneous tibial nerve stimulation improves female sexual function
in women with OAB
S. SALVATORE, C. Chapple, D. Sussman, S. Radomsky, P. Sand, S. Guard, J. Zhou, K. Sievert, V. Nitti
(MILANO)
AIM OF THE STUDY: Lower urinary tract dysfunctions are often associated and can alter sexuality in
both sex1. Percutaneous tibial nerve stimulation (PTNS) is a an established treatment for overactive bladder
(OAB) especially in women2 with potential use for other disorders such as faecal incontinence and sexual
dysfunction2,3. The aim of our study was to evaluate the prevalence of female sexual function and the effects
of PTNS on it, in women undergoing PTNS for OAB.
Aim of the study
Two 24-week, phase 3, randomized, double-blind, placebo-controlled studies demonstrated that
onabotulinumtoxinA (onabotA) 100U significantly decreases urinary incontinence (UI) and improves quality
of life (QOL) compared with placebo in patients with idiopathic overactive bladder syndrome (OAB) with
UI who were inadequately managed by at least 1 anticholinergic medication. Herein we present the third pre
specified interim analysis of a large, multicentre, 3-year, extension study that is being conducted to evaluate
the long-term efficacy and safety of repeated onabotA treatment for OAB.
Patients who completed either phase 3 study could enter a 3-year extension study in which they could
receive multiple intradetrusor injections of 100U onabotA (NCT00915525). Co-primary endpoints were
change from baseline (BL) at week 12 in mean daily UI episodes and the proportion of patients with a
positive treatment response (condition reported as ‘greatly improved’ or ‘improved’) on the Treatment
Benefit Scale (TBS). Additional assessments included change from BL in OAB symptoms, health-related
QOL (HRQOL) outcomes, duration of effect, adverse events (AEs), and clean intermittent catheterisation
(CIC). Data were integrated across all studies and were analysed by treatment cycle (up to 5 cycles).
Results
A total of 829 patients received at least 1 onabotA treatment; median duration of follow-up was 126
weeks (2.4 years). Discontinuations due to AEs/lack of efficacy were low (4.5%/4.9%). Following
onabotA treatment, mean daily UI episodes were reduced from a BL of 5.55 by -3.3, -3.7, -3.9, -3.2, and
-3.2 (treatments 1 5, respectively). Improvements were observed for other OAB symptoms, including
daily micturition episodes and urgency episodes. High proportions of patients (74.0, 80.9, 80.4, 79.4, and
86.1%) reported positive TBS responses at week 12 after onabotA (treatments 1-5). Clinically meaningful
improvements from BL were observed for HRQOL measures with repeated onabotA treatment. The median
duration of effect, measured as the time to patient request for retreatment, was 24.0, 31.6, 27.9, 24.3, and
23.9 weeks at treatments 1-5. The most common AEs were urinary tract infection, dysuria, urinary retention,
and bacteriuria, with no change in AE profile over time. CIC rates for any reason were low at 4.6%, 4.0%,
4.3%, 4.6%, and 2.9% at treatments 1-5.
Discussion
Results from this third interim analysis of the 3-year extension study show that repeated, long-term onabotA
treatment over more than 2 years resulted in sustained and clinically meaningful improvements in all OAB
symptoms, patient perception of improvement in their condition, and HRQOL. The safety profile of onabotA
was also consistent
Conclusions
Long-term, repeated onabotA 100U treatment in patients with OAB with UI who were inadequately
managed with at least 1 anticholinergic resulted in sustained improvements in OAB symptoms, patient
perception of improvement in their condition, and HRQOL, with no new safety signals.
142
MATERIALS AND METHODS: In our prospective study, from May to Oct 2013, we enrolled 27
consecutive women affected by idiopathic dry-OAB, refractory to conventional treatments. Exclusion criteria
were: pregnancy, history of urinary incontinence and/or chronic pelvic pain, assumption of antimuscarinics
psychoactive and/or oestroprogestinic drugs, history of psychiatric disorders, POP stage > 2 according to BadenWalker system (HWS), diabetes or other endocrinological diseases, uro-gynecological anatomic abnormalities
and/or neoplasia including endometriosis, genitourinary infections, complete denervation, absence of a stable
partnership for at least 3 months, no sexual activity over the last month before the enrolment. Patients suffering
of urinary incontinence were excluded to avoid interferences of incontinence episodes on sexual activity.
Sexuality was assessed by female sexual function index (FSFI): patients with a FSFI score ≤26,55 were
considered as presenting a female sexual dysfunction (FSD). Patients were evaluated before and after PTNS
by means of a 24-h bladder diary, OAB-q SF and FSFI questionnaires. Patients showing a reduction ≥50%
of urgency episodes were considered OAB “objective responders”. Patients requiring to continue chronic
treatment in order to maintain the obtained response were considered OAB “subjective responders”. Patients
with a pre-treatment FSFI score ≤26,55 who showed a post-treatment FSFI score >26,55 after PTNS (if the
increase in FSFI was ≥20%), were considered FSD “objective responders”.
All patients were treated by a 12 weekly 30 minutes PTNS sessions. Patients underwent electrical stimulation
with an adjustable pulse intensity, a fixed pulse width of 200 ms and a frequency of 20 Hz (Urgent PC®,
Neuromodulation System available from Uroplasty, Inc., Minnetonka, MN).
Paired t-student test was applied to compare bladder diaries, questionnaires scores at each baseline and at the
end of the PTNS round. A p value ≤0,05 was considered significant. Correlations analysis between differences
in FSFI and OAB-q SF scores were evaluated by Pearson’s test. Finally, descriptive statistical tests were used
to compare demographics and clinical information between the two groups.
RESULTS: Twenty-five females out of 27 patients enrolled (92.6%) were evaluable. One woman was
excluded due to absence of sexual intercourses during follow-up and one female patient dropped out the
study. Fifteen out of 25 pts (60%) were considered “subjective responders” and 12 pts (48%) were considered
“objective responders” for OAB. Fourteen out of 25 patients (56%) were considered affected by FSD. Baseline
demographic and clinical parameters of patients are reported in table 1 for patients with and without FSD.
Validated quantification of sexual function demonstrated significant improvements in overall sexual function,
arousal and desire in both groups. Results are reported in table 2. In particular, 5/14 pts (35,7%) with FSD
resulted to be FSD “objective responders” with a mean FSFI score pre-PTNS of 16,16 (range 10,8-19,7)
vs 31,62 (range 29,1–34,2) after PTNS. Statistically significant improvements in urinary function occurred
in patients either with or without FSD. In particular, the mean number of daytime urgency episodes in 24h
bladder diary decreased significantly in both groups; Moreover, statistical significant changes in the mean
OAB-q SF scores were found. Correlation between OAB-q SF Symptom Bother score and sexual function
was statistically significant (r= 0.45; p=0.02), as well among OAB-q SF HRQL score and FSFI (r=0.54;
p=0,01), thus the improvement of FSD seems due to reduction of urinary symptoms.
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DISCUSSION: Our results show that a large number of women with refractory idiopathic dry-OAB treated
with PTNS could be affected also by sexual dysfunction. In our series 14/25 patients (56%) were diagnosed as
presenting FSD by the FSFI score. It is interesting to observe that PTNS may cause a significant improvement
of FSFI in women with OAB: a total normalization of the sexual function was observed in 5/14 patients
(35,7%) complaining sexual disturbances before treatment, whilst an improvement was observed in almost all
patients. This improvement seems related to the amelioration of urinary symptoms.
CONCLUSIONS: To our knowledge only one study investigated the effect of PTNS on sexuality in a
heterogenous population3. Our data seem to support that improvement in the quality of sexual function in
female patients with OAB correlates with improvement in urinary symptoms. Further studies are needed to
confirm these findings.
REFERENCES: Heidler S, Mert C, Wehrberger C, Temml C, Ponholzer A, Rauchenwald M, Madersbacher
S. Impact of overactive bladder symptoms on sexuality in both sexes. Urol Int. 2010;85(4):443-6.
2 EAU Guidelines on urinary incontinence, www.uroweb.org, 2013
3 Van Balken MR, Verguns H, Bemelmans BLH. Sexual functioning in patients with lower urinary tract dysfunction improves after percutaneous tibial nerve stimulation. Int J Impot Res. 2006 Sep-Oct;18(5):470-5
Percutaneous tibial nerve stimulation improves female sexual function
in women with OAB
AIM OF THE STUDY: Lower urinary tract dysfunctions are often associated and can alter sexuality in
both sex1. Percutaneous tibial nerve stimulation (PTNS) is a an established treatment for overactive bladder
(OAB) especially in women2 with potential use for other disorders such as faecal incontinence and sexual
dysfunction2,3. The aim of our study was to evaluate the prevalence of female sexual function and the effects
of PTNS on it, in women undergoing PTNS for OAB.
MATERIALS AND METHODS: In our prospective study, from May to Oct 2013, we enrolled 27
consecutive women affected by idiopathic dry-OAB, refractory to conventional treatments. Exclusion criteria
were: pregnancy, history of urinary incontinence and/or chronic pelvic pain, assumption of antimuscarinics
psychoactive and/or oestroprogestinic drugs, history of psychiatric disorders, POP stage > 2 according to BadenWalker system (HWS), diabetes or other endocrinological diseases, uro-gynecological anatomic abnormalities
and/or neoplasia including endometriosis, genitourinary infections, complete denervation, absence of a stable
partnership for at least 3 months, no sexual activity over the last month before the enrolment. Patients suffering
of urinary incontinence were excluded to avoid interferences of incontinence episodes on sexual activity.
Sexuality was assessed by female sexual function index (FSFI): patients with a FSFI score ≤26,55 were
considered as presenting a female sexual dysfunction (FSD). Patients were evaluated before and after PTNS
by means of a 24-h bladder diary, OAB-q SF and FSFI questionnaires. Patients showing a reduction ≥50%
of urgency episodes were considered OAB “objective responders”. Patients requiring to continue chronic
treatment in order to maintain the obtained response were considered OAB “subjective responders”. Patients
with a pre-treatment FSFI score ≤26,55 who showed a post-treatment FSFI score >26,55 after PTNS (if the
increase in FSFI was ≥20%), were considered FSD “objective responders”.
All patients were treated by a 12 weekly 30 minutes PTNS sessions. Patients underwent electrical stimulation
with an adjustable pulse intensity, a fixed pulse width of 200 ms and a frequency of 20 Hz (Urgent PC®,
Neuromodulation System available from Uroplasty, Inc., Minnetonka, MN).
Paired t-student test was applied to compare bladder diaries, questionnaires scores at each baseline and at the
end of the PTNS round. A p value ≤0,05 was considered significant. Correlations analysis between differences
in FSFI and OAB-q SF scores were evaluated by Pearson’s test. Finally, descriptive statistical tests were used
to compare demographics and clinical information between the two groups.
RESULTS: Twenty-five females out of 27 patients enrolled (92.6%) were evaluable. One woman was
excluded due to absence of sexual intercourses during follow-up and one female patient dropped out the
study. Fifteen out of 25 pts (60%) were considered “subjective responders” and 12 pts (48%) were considered
“objective responders” for OAB. Fourteen out of 25 patients (56%) were considered affected by FSD. Baseline
demographic and clinical parameters of patients are reported in table 1 for patients with and without FSD.
Validated quantification of sexual function demonstrated significant improvements in overall sexual function,
arousal and desire in both groups. Results are reported in table 2. In particular, 5/14 pts (35,7%) with FSD
resulted to be FSD “objective responders” with a mean FSFI score pre-PTNS of 16,16 (range 10,8-19,7)
vs 31,62 (range 29,1–34,2) after PTNS. Statistically significant improvements in urinary function occurred
in patients either with or without FSD. In particular, the mean number of daytime urgency episodes in 24h
bladder diary decreased significantly in both groups; Moreover, statistical significant changes in the mean
OAB-q SF scores were found. Correlation between OAB-q SF Symptom Bother score and sexual function
was statistically significant (r= 0.45; p=0.02), as well among OAB-q SF HRQL score and FSFI (r=0.54;
p=0,01), thus the improvement of FSD seems due to reduction of urinary symptoms.
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P 142
DISCUSSION: Our results show that a large number of women with refractory idiopathic dry-OAB treated
with PTNS could be affected also by sexual dysfunction. In our series 14/25 patients (56%) were diagnosed as
presenting FSD by the FSFI score. It is interesting to observe that PTNS may cause a significant improvement
of FSFI in women with OAB: a total normalization of the sexual function was observed in 5/14 patients
(35,7%) complaining sexual disturbances before treatment, whilst an improvement was observed in almost all
patients. This improvement seems related to the amelioration of urinary symptoms.
CONCLUSIONS: To our knowledge only one study investigated the effect of PTNS on sexuality in a
heterogenous population3. Our data seem to support that improvement in the quality of sexual function in
female patients with OAB correlates with improvement in urinary symptoms. Further studies are needed to
confirm these findings.
REFERENCES (max. 3): Heidler S, Mert C, Wehrberger C, Temml C, Ponholzer A, Rauchenwald M,
Madersbacher S. Impact of overactive bladder symptoms on sexuality in both sexes. Urol Int. 2010;85(4):4436.
2 EAU Guidelines
on urinary incontinence, www.uroweb.org, 2013
Van Balken MR, Verguns H, Bemelmans BLH. Sexual functioning in patients with lower urinary tract dysfunction improves after percutaneous tibial nerve stimulation. Int J Impot Res. 2006 Sep-Oct;18(5):470-5
3
OUTCOMES AND POST-OPERATIVE COMPLICATIONS OF ROBOT-ASSISTED
LAPAROSCOPIC HYSTEROSACROPEXY: INITIAL EXPERIENCE
P. Curti, C. D’Elia, M. Cerruto, F. Cavicchioli, F. Bianconi, N. De Luyk, M. Balzarro, S. Cavalleri, W.
Artibani (Verona)
Aim of the study
Pelvic organ prolapse is a common condition, affecting about 50% of women with children. It has been
estimated that one in nine women will undergo a hysterectomy in their lifetime; moreover, more than 10%
of these women may need surgical repair of a major vaginal prolapse. Until now, only few studies have
been addressed to assess the outcomes of robot-assisted laparoscopic hysterosacropexy (RALHSP) and no
randomized controlled trials or meta analysis have been conducted. The aim of our study was to evaluate the
results and complication rate with standardized criteria in a consecutive series of female patients undergoing
RALHSP.
A medical record review of all female patients consecutively undergone RALHSP for hysterocele > stage II
from February 2010 to November 2013 was performed. Patients’ demographic and clinical characteristics
and intra- and post-operative (PO) variables were recorded. Variable collected included age, BMI, prolapse
stage, parity, comorbidities, lower urinary tract symptoms (LUTS) associated, operative time, blood loss,
postoperative (PO) complications, PO catheter removal, hospital discharge. All complications within 90
days of surgery were recorded and graded according to the Clavien-Dindo system. Patient satisfaction was
evaluated using a VAS scale from 0 to 10.
Results
Fifteen patients were included in the analysis. All patients had uterine prolapse stage > II +/- anterior
prolapse +/- urodynamic stress urinary incontinence (USI). Mean age was 58.26 + 11.08 years; median
parity was 2 and mean BMI was 24.2 + 2.14. All patients had uterine or vaginal prolapse stage > 2 and
2 patients showed a concomitant USI. Median total operative time was 110 minutes (range: 75 - 205
minutes) and median estimated blood loss was 0 cc (range: 0 – 50 cc). All patients underwent RALHSP
2/15 underwent a concomitant TVT- O positioning for USI without and with anterior colporraphy (because
of an anterior vaginal wall defect). There was no intraoperative complication and no need of intra or postoperative blood transfusion. The median catheterization time was 3 days (range: 1- 4 days) and mean
hospitalization time was 4 days (range: 3-6 days); more than 50% of the patients were discharged within
PO day 4. According to the Clavien-Dindo system, grade 1 early complications occurred in 26.6% of cases
(4/15) and one patient (6.6%) had a grade 2 complication; no higher grades were observed. At a median
follow up of 35 months a median satisfaction score of 9 (range 0-10) has been reported, with only 3 out of
15 patients reporting a significant prolapse relapsing.
Discussion
Comparing our data with the literature, our results were better or at least overlapping. A limitation of the
study is the small number of patients, however higher than literature.
Conclusions
In our hands RALHSP is easy to perform, with satisfying mid-term outcomes and a low complication rate.
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POP REPAIR WITH TROCAR-GUIDED TRANS-VAGINAL MESH SURGERY. NOT
ONLY ANATOMIC RESULTS BUT ALSO IMPACT ON URINARY INCONTINENCE AND
FUNCTIONAL OUTCOMES
ROBOTIC SACROCOLPOPEXY: A SINGLE CENTER EXPERIENCE ON OUR FIRST 65 CASES
E. Costantini, F. Natale, G. Vittori, E. Salvini, A. Pastore, M. De Biase, E. Sarti, M. Cervigni (Perugia)
Aim of the study
The primary objective was to assess the effect on continence of trocar-guided transvaginal mesh for POP
repair, with at least 2-years follow-up. Secondary objectives were anatomical correction, relief of symptoms
and effect on quality of life.
We enrolled patients with symptomatic stage >2 POP. Primary outcomes was evaluation of post-operative
incontinence using the Ingelman-Sundberg scale. Secondary outcomes were: objective anatomical results
(objective cure for points Ba, C and Bp was at stage 0, and satisfactory at stage 1); resolution of symptoms;
evaluation of quality of life. Statistical analysis: McNemar chi-square test, paired t-test and Mann-Whitney
test
Results
We enrolled 81 women that underwent vaginal prolapse repair with mesh placed via double trans-obturator
approach (Perigee™ System). In 31 patients a vaginal hysterectomy was performed. We included in the final
evaluation 72 patients with at least 2 years follow-up. Pre-operatively SUI was present in 32 patients and
urgency urinary incontinence in 44 patients. Post-operatively 14% developed de-novo SUI (grade I in 5 pats,
grade II in 1). In the pre-op incontinent group, among 20 patients with grade I SUI, 65% became continent
and 35% showed persistent low grade SUI. In the 12 patients with grade II/III SUI, 41.6% became continent,
50% had a grade I and 1 patients had a grade II SUI. Only two patients decided to undergo subsequent SUI
surgery. Beyond this, we had a significant improvement in storage, voiding, post-micturition, and prolapserelated symptoms and in 10 cases we observed a mesh exposure. We had an anatomical cure rate for the
anterior compartment in 80.8% of the sample and for the apical segment in 91.4%. In 6 out of 7 patients
apical recurrences occurred when uterus was not removed during POP surgery. The anatomical cure rate for
the posterior segment was 93.1%. We had a post-op statistically significant reduction of detrusor pressure
at maximum flow and a statistically significant increase in maximum flow Detrusor overcativity (DO),
present pre-operatively in 25 patients, disappeared in 56% of cases. In 4 pats DO appeared “de novo”. The
King’s Health Questionnaire (KHQ) showed patients reported better scores in all domains except personal
relationship. We had no significant differences.comparing the results of KHQ of post-op continent and
incontinent patients.
Discussion
Our study demonstrates that the use of prophylactic or therapeutic anti-incontinence procedure at the time of
trans-vaginal POP-repair is an overtreatment. In the preoperative continent patient, incontinence appeared
“de novo” in 14% of the cases while in the pre-operative incontinent patients, 56.3 % resolved with only
POP-repair and another 40% presented a low grade incontinence, clinically not relevant for their QoL.
Conclusions
Trocar-guided transvaginal mesh surgery for severe POP showed excellent anatomical and functional results.
In case of severe uterine prolapse hysterectomy should be performed to avoid recurrences.
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L. Dutto, S. O’Sullivan, M. Hewitt, M. Di Biase, B. O’Reilly (Oxford, Regno Unito)
Aim of the study
To report outcomes of robotically assisted laparoscopic sacrocolpopexy (RASC) in a high volume center
Background: laparoscopic sacorocolpopexy (LSC) has established itself in the last two decades and has
shown to produce similar results to abdominal sacrocolpopexy (ASC). RASC seems promising, but literature
on this topic is still scarce.
We performed a retrospective analysis on 65 consecutive patients operated with RASC between August 2008
and January 2012. Two surgeons performed the procedures (fellow mentoring was included in the last 20
cases). Besides demographic information, we recorded intra-, peri- and postoperative variables like operative
time, complications, and concomitant procedures. Objective success (defined as POP-Q stage ≤1), subjective
success (satisfaction with surgery), pre- and postoperative symptoms, postoperative pain (VAS scale 0-10: 0
= no pain, 10 = unbearable pain) and time to return to normal activities were assessed. Follow up visits were
done at 6 weeks, 6 months, 1 year, then yearly.
Results
Mean age was 61 years (39 –80), mean parity 3,5 (0 – 8), mean BMI 25,2 (37,3 – 20). All patients had
undergone previous hysterectomy, 49,2% had previous POP repair and 32,3% had previous laparotomic
surgery. All patients had prolapse stage ≥ 2 (A ≥ 2 = 71%, B ≥ 2 = 46%, C ≥ 2 = 98%). Operating time
-excluding docking and undocking- was 130 (208 - 75) minutes, mean hospital stay was 1,7 days (1 - 10)
and mean pain on postoperative day 1 was 2,4 (0 – 7). We recorded 5 conversions, 3 to open surgery and 2
to vaginal repair. Additional procedures were performed in 30% of cases and perioperative complications
occurred in 11 patients (16,9%). Six patients were lost to follow up. Objective success (defined as POP-Q
≤1) at 6 weeks was: 96,3% at vault and 79,6% at any point, while at mean follow (11,9 months, range 1,5
– 39) success at the vaginal vault was 89,8% and 67,4% for any POP-Q point. Reoperations for recurrence
were necessary in 5/54 patients (9,25%), while 1 patient had developed lumbar discitis, which required mesh
removal. No mesh erosions were recorded. Satisfaction with surgery was 81,6%, with 31 patients being very
satisfied and 9 moderately satisfied. The incidence of any bulge-related symptoms decreased from 100%
preoperatively to 46,9% at follow up (see table for details).
Discussion
RASC seems to be feasible, promising and warrants good results. We need to put more emphasis into
research on this subject, as the novelty of this approach may create some biases; e.g. most research in
this field includes it’s own learning curve. Furthermore extrapolation of data on functional results may be
lacking, when performed in a retrospective setting.
Conclusions
Our experience with RASC is amongst the largest series on this topic available in literature. RASC produces
good objective, subjective and functional results, with reasonalble complication and recurrence rates, which
are comparable to the open and laparoscopic series present in literature.
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Treatement of vesico-vaginal fistula through a laparoscopic transperitoneal exravesical approach
Giuseppe Giusti; Antonello De Lisa
The S.A.C.S. (Safety–Anatomy–Continence–Satisfaction) score in evaluating
P.O.P. (Pelvic Organ Prolapse) surgery: a proposal
Clinica Urologica SS. Trinità , University of Cagliari
Objectives
This study aims to verify the feasibility and effectiveness of the correction of vesicovaginal fistulae (VVF)
secondary to hysterectomy, through a laparoscopic transperitoneal extravesical approach and Tachosil
application.
Methods and materials
since July 2010 6 patients, who underwent hysterectomy, and suffered from postoperative urinary leakages
from the vagina, caused by a vesicovaginal fistula (VVF), were managed. Pelvic examinations, cystoscopy
and cystography were performed in order to localize the fistula and determine its dimensions.
The localisation of the fistula in the supratrigonal region and the experience developed by our department in the
usage of laparoscopic techniques, led the surgeons to choose a transabdominal videolaparoscopic approach.
Patients were placed in the lythotomy position with a 20° Trendelemburg. 5 operating ports were placed using
a diamond disposition. First the supravesical peritoneum was dissected. Then the vesicovaginal surface was
exposed to better identify the fistula, which was eventually resected.
The vesical and vaginal accesses were closed in 2 layers. 2 layers of Tachosil (4cmx4cm) were placed between
the sutures, while the supravesical peritoneum was closed with clips. The mean operative time was of 251
minutes, mean hospital stay of 4 days and the vesical catheter could be removed after an average of 10 days.
All patients were examined after one month.
Introduction
Urogenital prolapse or pelvic organ prolapse POP is an highly prevalent disease; although underestimated,
the herniation of the pelvic organs to or beyond the vaginal walls is a common condition, and if untreated it
remains an important cause of morbidity in women influencing quality of life (QoL).
There is no overall consensus in defining cure in prolapse surgery. This because the symptoms of prolapse
are variable and the degree of prolapse does not correlate directly with symptoms. Moreover, there are many
surgical approaches to pelvic organ prolapse with heterogeneous data.
To address this query, we introduce the S.A.C.S. (acronym for Satisfaction–Anatomy–Continence–Safety)
score in the prospective evaluation of success of pelvic organ prolapse surgery in a consecutive series of
women.
The objectives of current study are (1) to propose a standardized, original scoring system of pelvic organ
prolapse surgical outcomes; (2) to evaluate the relationship between this score and pre-operative status.
Conclusions
The technique described allows for an adequate repair of vesico-vaginal fistulae. We feel we can recommend
this approach as one with lower morbidity compared to the traditional one, in case of surgeons with high
laparoscopic skills.
We prospectively evaluated patients affected by urogenital prolapse, who were candidates for open sacropexy.
Inclusion criteria was the presence of a >2 grade urogenital prolapse requiring colposuspension with sacropexy,
and at least 24 months complete follow up.
After surgery, patients were evaluated at 24 months by mean of outcomes scoring system S.A.C.S. (Satisfaction,
Anatomy, Continence, Safety).
Satisfaction: we used the Patient Global Improvement Inventory (PGII) scale. For the definition of complete
success, we used a very stringent criteria, i.e. when the patients answered they fill very much better or much
better. Value= 1.
Anatomy: to verify anatomical success of sacropexy in the correction of urogenital prolapse, we used the
Pelvic Organ Prolapse Quantification system (POP–Q). According to POP-Q, for the definition of complete
success we used a very stringent criteria, i.e. the absence of any >=2 stage prolapse.
Continence: for the definition and grading of post-operative continence, we tested UDI-6; however, we
considered a complete success the absence of any degree of urine leakage.
Safety: for analyzing safety of procedure, we used the Clavien-Dindo classification of surgical complications
We used the suffix ‘d’ for the presence of complications at discharge, and introduced ‘d’ for the presence of
delayed complications, including mesh-related complications (i.e. mesh-erosion) requiring surgery, or bowel
delayed complications (i.e. de-novo constipation), or vagina delayed complications (i.e. dyspareunia).
We considered success the absence of more than grade 2 and any ‘delayed’ Clavien-Dindo complications.
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Results
No intraoperative or postoperative complications occurred. After a follow-up period of one month, all patients
showed complete continence and a good quality of life.
Discussion
Vesicovaginal fistulae are the most common fistulae of the urinary tract. In the developed world they are
most commonly caused by iatrogenic damages during hysterectomy, with the percentage of iatrogenic vesical
damage being estimated between 0,5% and 1%. Patients normally present a continuous urinary leakage
per vagina. There is no agreement over the preferred approach to treat this kind of fistulae. What seems to
be important is the level of experience of the surgeon on the technique he uses. The open trans-abdominal
approach is classically recommended in case of supratrigonal located fistulae or anyway in case of inadequate
exposition caused by highly located fistulae in a narrow vagina.
The laparoscopic technique presents the same strong points of the open approach. It has however a lower
morbidity and it is associated with shorter hospital stays. At present, there are no studies at the national level,
indexed in pubmed, describing the technique we use.
Perfect scoring system according to SACS were defined as the sum of Satisfaction plus Anatomy plus
Continence plus Safety, equal to 4.
The SACS scoring system was tested by comparing at follow-up answer from a simple yes/no question: ‘if
you had it to do surgery over again, would you still do it?’.
At long term follow-up, it is not still clear which negative outcome (de novo incontinence, bowel dysfunction,
dyspareunia, surgical complication) has major influence on overall, long-term, satisfaction rate, since different
outcomes have different impact upon quality of life. Only an extensive validation of this score system will
answer to some still unanswered questions.
Results
233 consecutive patients were enrolled.
54 underwent hysterocolposacropexy, 71 colposacropexy for vaginal vault prolapse and 108 contemporary
hysterectomy and colposacropexy.
At 24 months follow up, according to each single score:
Satisfaction: 194 patients (83.2%) had a PGII score corresponding to the perfect goal (‘much better or better’).
Anatomy: 228 patients (97.8%) had a POP-Q score of residual prolapse < 2°.
Continence: 224 patients (96.1%) reported the absence of any degree of urine leakage.
Safety: according to Clavien-Dindo classification of surgical complications, 199 patients (85.4%) had less
than grade 2 or delayed complications according to definition.
Analyzing the SACS score, 160 patients (68.6%) obtained a complete success for each point, scoring 4 at
SACS score which, at Spearman correlation analysis, highly corresponds to the overall satisfaction expressed
by the simple yes/no question (p=0.000).
Conclusions
The quadrifecta score system analyzing the 4 main goals of surgical correction of pelvic organ prolapse seems
to be a global, easy reproducible tool in the long-term evalution of outcomes.
External validation of the score is necessary.
At multivariate analysis including age, BMI, pre-operative incontinence, grade of prolapse, type of surgery,
only the BMI was independent, negative predictor of maximum SACS score (p=0.04), while the presence of
pre-operative stress incontinence approaches statistical significance (p=0.055).
Discussion
There are several challenges in defining cure in prolapse surgery, since the symptoms of prolapse are variable
and the degree of prolapse does not correlate directly with symptoms. Moreover, there are many surgical
approaches to pelvic organ prolapse.
Finally, there is a lack of standardized definition of cure since the data on prolapse surgery outcomes are
heterogeneous. Therefore, the treatment of pelvic organ prolapse is challenging due in part to the lack of
correlation between anatomy and symptoms, as well as to the lack of standardization of outcome measures.
Ideally, we have four main goals: no anatomic prolapse, no functional symptoms, patient satisfaction, and
the avoidance of complications. What is most important is that the driving force in defining cure of prolapse
should be patient symptoms.
The proposed quadrifecta score by mean of S(atisfaction) A(natomy) C(ontinence) S(afety) aimed to standardize
and define in a comprehensive way all the goal of prolapse surgery.
Although it will open an ongoing discussion and although not externally validated, in internal cohort the
SACS score correlate with global patient’s satisfaction, simply expressed by the yes/no question on ‘if you had
it to do surgery over again, would you still do it?
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URINARY RETENTION AFTER TRANS OBTURATOR TAPE (TOT) PROCEDURE. ONE
CENTER EXPERIENCE.
Urodynamics before surgery for stress urinary incontinence in female
patients is it necessary
V. Galica, E. Toska, P. Saldutto, S. Masciovecchio, G. Paradiso Galatioto, C. Vicentini (Teramo)
Introduction & Objectives
Aim of the study
We reviewed our experience with persistent retention after the TOT procedure and reported our treatment
results.
Recently the role of the urodynamic evaluation (UE) before surgery for female urinary stress incontinence
has been questioned. Data coming from very selected patients (called “uncomplicated”) show that a
preoperative office evaluation alone is not inferior to an evaluation with UE (VALUE trial, N Engl J
Med 366;21: 1987-97, 2012). Aim of this retrospective multicenter single nation study was to investigate
the percentage of “uncomplicated” patients coming to UE in several referral centers of a single nation.
Secondary aims of the study were to assess in how many women the UE obtains observations that differ
from to the pre-urodynamic clinical picture and in how many women these findings could affect the
consequent management.
We reviewed the charts of 170 TOT procedures that we have performed from April 2005 till November
2012. Of these 7 patient (4%) developed urinary retention or symptoms consistent with obstruction including
hesitancy, straining to void, or feeling of incomplete emptying, lasting more than 1 week from the date of
procedure. We reviewed the operative record , noting the operative time, presence of urethral injury, and
any reported complication. Initially all the patients underwent a conservative treatment using α-adrenergic
blockers and urethral dilatation. Of the 7 patients only 5 patients subsequently underwent transvaginal
release of the mesh within 12 weeks. We performed a unilateral incision of the sling.
Results
Seven patients developed urinary retention after TOT. Two patients had a urethral dilatation and were treated
with α-adrenergic blockers for a mean time of 5 days. At the discharge the post-voiding residual urine
measured 50 ml and 60 ml respectively. De novo urgency was reported in 1 patient and it was successfully
treated with solifenacin 5mg. The other 5 patients who underwent a unilateral sling release voided to
completion within 6 hours. None of the patients reported further subjective complaints of outlet obstruction.
All the patients who underwent the mesh release were continent. The mean operative time was about 13
minutes and no urethral injury occurred.
Material & Methods
This is a retrospective multicentric single-nation study. Data were extracted from the urodynamic databases
of six referral centers of a single nation; history, objective examination, urodynamic report and traces of
female patients who underwent an urodynamic evaluation prior surgery for stress urinary incontinence in the
last five years were considered. Patients considered were classified according to the VALUE trial inclusion/
exclusion criteria in “uncomplicated” or “complicated”. The urodynamic observations were compared
with pre-urodynamic data and considered different if: a different type of incontinence was diagnosed (e.g.
stress instead of mixed or vice versa or pure urge incontinence) or a voiding dysfunction was diagnosed.
Different urodynamic observations were separately evaluated in the group of patients “uncomplicated” and
“complicated”. The percentage of patients in whom the planned surgery was changed or cancelled after UD
was also recorded.
Results
Discussion
Data shows that up to 20% of patients will have new urinary complaints after incontinence surgery. A
properly placed suburethral sling does not produce obstruction as long as excessive tension is avoided.
Treatment of urinary retention can begin conservatively with α- adrenergic blockers, urethral dilatation
and clean intermittent catheterization but the majority of patients will, however require the sling incision.
Several surgeons prefers a midline sling incision and subsequently if the relaxation of urethral support is
not adequate unilateral or bilateral incision of the sling as it enters the endopelvic fascia. In this study only a
unilateral incision was performed, choosing when was possible the side where a higher tension of the sling
was evident and also in order to avoid urethral injury. Early relief of obstruction can be associated with a
lower incidence of permanent voiding dysfunction than if treatment for obstruction is delayed.
Conclusions
Urinary retention can be a complication after TOT. If no urethral injury occurred during the operative time
a conservative approach may be considered. The release of the mesh by an unilateral incision, in local
anesthesia is a valid alternative with a rapid return to normal voiding. In our experience all the patients
remained dry. There is general agreement that early relief of obstruction is associated with lower incidence
of permanent voiding dysfunction.
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From six databases containing 12565 UE, data of 2053 female patients were extracted. 740/2053 patients
(36.0%) were considered “uncomplicated” according to the definition used in the VALUE trial. The
urodynamic observations were considered different from the pre-urodynamic diagnosis in 1276 out of
2053 patients (62.2%). A voiding dysfunction was diagnosed in 394 patients (19.2%). The urodynamic
observation differed from the pre-urodynamic clinical picture significantly more frequently in the
“complicated” than in “uncomplicated” patients (74.6% vs. 40%, p=0.0001). The same was observed for
the diagnosis of a voiding dysfunction, present in the 22.5% and in the 13.4% of the “complicated” and
“uncomplicated” patients, respectively (p=0.0001). In 151 (111+40) (9.5%) and 153 (130+23) (9.7%)
on 1582 patients in whom data about clinical management after UE were available, planned surgery was
cancelled or modified, respectively. Again, the management strategy was modified more frequently in the
“complicated” patients (23.8% vs. 11%, p=0.0001).
Conclusions
According to our data, coming from huge databases of six referral centers in a single nation, the
“uncomplicated” patients represent a minority (36%) of the patients evaluated before surgery for
female stress incontinence. In the majority of them, the “complicated” ones, UE is able to provide new
informations, in comparison to the clinical examination, in 74.6% of cases and to change the consequent
management in 23.8% of cases.
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UTERINE PRESERVATION IN PELVIC ORGAN PROLAPSE USING ROBOT ASSISTED
LAPAROSCOPIC SACROHYSTEROPEXY: QUALITY OF LIFE AND TECHNIQUE.
ANALYSIS OF RADICAL CYSTECTOMY COMPLICATIONS IN PATIENTS PREVIOUSLY
TREATED BY PELVIC RADIOTHERAPY
R. Nucciotti, F. Costantini, A. Bragaglia, F. Mengoni, G. Passavanti, F. Viggiani, C. Brunettini, V. Pizzuti
(Grosseto)
M. Allasia, F. Soria, A. Battaglia, A. Gonella, F. Marson, A. Palazzetti, G. Melloni, E. Alessandria, E.
Garzino, A. Bosio, P. Destefanis, P. Gontero, B. Frea (Torino)
Scopo del lavoro
Abdominal sacrocohysteropexy is the gold standard treatment for pelvic organ prolapse and can be
performed laparoscopically. Robotic assistance allows optimal dissection and placement of the mesh. We
present a video of our technique along with the results on 160 patients.
Aim of the study
Radical cystectomy in patients with a history of pelvic radiation therapy is often a challenging and high
risk surgical procedure. We retrospectively evaluated data from patients underwent radical cystectomy and
urinary diversion in our Centre. We focused on the management and early complication rates in those who
previously received high dose pelvic radiation for any cause.
Materiali e metodi
We perform a posterior dissection down to the levator muscles and an anterior dissection down to the
trigone. The meshes are made of polypropylene . The posterior mesh, “butterfly” shaped is sutured to the
levator muscles, to the rectum above the anorectal junction and to the uterosacral ligaments. The anterior
mesh is sutured to the vagina and the isthmus/cervix and attached to the promontory with a tension measured
through a vaginal exam.
Risultati
We operated on 160 patients. The mean operative time was 130 min (118–170). Perioperative complications
were one vaginal effraction . The mean hospital stay was 3 days (2–5). The mean follow-up is 12
months (range 2–16) . We observed no retraction of the prosthesis and no dyspareunia.With this type of
conformation of the posterior mesh we have significantly reduced the dischezia.
Discussione
We consider unnecessary remove uterus and promontory attached of the posterior mesh, reducing the risk of
erosion, constipation and dischezia
Conclusioni
With this technique we performed a complete treatment for severe prolapse by a minimally invasive
approach with a low rate of recurrence at this point.
Patient medical records were retrospectively reviewed. Any patients that underwent a radical or salvage
cystectomy for any diagnosis has been included in the study. The following parameters were collected:
indication to surgery, previous pelvic radiation therapy (for any pelvic caner), intra and post-operative
complication, hospital stay, blood losses, post-discharge follow-up. The complications were graded using the
Clavien - Dindo classification.
Results
Between 2005 and 2012 we collected 330 patients who underwent radical cystectomy, among these 17
(5.2%) were previously treated with pelvic radiotherapy (PRT). Median age was 72 years (59-88). Median
follow-up was 45 months (1-102). PRT was performed as primary RT for prostate cancer (5 patients
external, 1 patient brachitherapy), as adjuvant therapy following radical prostatectomy (3 patients), as
multimodal therapy for muscle-invasive bladder cancer (chemo-radioteraphy, 3 patients), as treatment for
gynecological malignancy (4 patients) and, in one case, as adjuvant treatment following surgery in rectal
cancer. Radical cystectomy was performed in 9 cases for muscle-invasive bladder cancer, in 3 cases for
local progression of primary pelvic disease and in 5 cases for radiation induced cystitis. Urinary diversions
performed were ileal conduit in 12 patients (70.6%) and cutaneous ureterostomy in 5 patients (29.4%).
A total of 11 (65%) complications were identified: grade 1 in 5.9%, grade 2 in 23.5%, grade 3 in 29.4%,
grade 4 in 0% and grade 5 in 5.9%. No complication was seen in 35% of the patients. Complication rate
(Clavien-Dindo score 1-5) of radical cystectomy performed in patients (313) without PRT history was 30%
with a statistical significant difference (P=0,02). Urinary diversion type was not related with occurence of
complications.
Discussion
The early complication rate using a standardized reporting system in patients undergoing radical cystectomy
after radiation therapy is higher than previously published in nonirradiated subjects. In this selected serie
65% of patients experienced complications.
Conclusions
This revision shows as RC in PRT is still afflicted by an high rate of surgical complications and has to
be done in selected and well informed patients. Patients should be also well informed before undergoing
radiation therapy (especially for bladder cancer), that a subsequent salvage cystectomy would be a procedure
with a high risk of complications.
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ASSOCIATION BETWEEN URINARY DIVERSION AND HEALTH RELATED - QUALITY
OF LIFE (HR-QOL) AFTER RADICAL CYSTECTOMY: RESULTS FROM A MULTICENTRE
CROSS-SECTIONAL COHORT STUDY
CONTINENCE RECOVERY IN PATIENTS UNDERGONE RADICAL CYSTECTOMY AND
ILEAL ORTHOTOPIC NEOBLADDER
M. Cerruto, C. D’Elia, G. Cacciamani, D. De Marchi, S. Siracusano, M. Iafrate, M. Niero, C. Lonardi, P.
Bassi, E. Belgrano, C. Imbimbo, M. Racioppi, R. Talamini, S. Ciciliato, L. Toffoli, M. Rizzo, F. Visalli, P.
Verze, W. Artibani (Verona)
Aim of the study
Bladder cancer is a disease which plays an important role in urological clinical practice. When a radical
cystectomy(RC) is indicated, the ideal urinary diversion after RC should be easy to prepare and easy to
handle, presenting few complications, low mortality and morbidity; moreover it should protect the upper
urinary tract function and should be well accepted by the patient, thereby ensuring the best Health-Related
Quality of Life (HR-QoL) as possible. The aim of our study was to assess the association between type
of urinary diversion and HR-QoL in patients who underwent RC for primary bladder cancer using both
validated and not validated questionnaires.
A multicentre cross-sectional cohort study was planned involving 5 academic urological centres. A cohort of
319 patients treated with radical cystectomy and urinary diversion for primary bladder cancer was analysed.
Patients’ HR-QoL was assessed using a phone administered questionnaires by and independent interviewer
(EORTC QOL C-30, EORTC BLM-30, STOMA QOL; IOB-PRO). Univariable and multivariable linear
regression analyses were used to examine the association between type of urinary diversion (ileal conduit
versus orthotopic neobladder) and HR-QoL.
Results
Overall 148 patients with ileal conduit and 171 patients with orthotopic neobladder were recruited. Mean
age of the patients with ileal conduit was 71 years, whereas mean age of patients with ortothopic neobladder
was 66 years. The median follow up duration was 48.35 ± 39.20 months. Univariate analyses showed
significant differences favoring orthotopic neobladder urinary diversion with more favorable HR-QoL scores
on EORTC QOL C-30 compared to ileal conduit concerning the following domains: physical functioning
(80.82 ± 21.99 vs 74.73 ± 24.81, p = 0.006), emotional functioning (84.89 ± 20.87 vs 78.66 ± 24.65, p =
0.023), cognitive functioning (93.08 ± 12.62 vs 85.36 ± 21.19, p = 0.000), fatigue (19.49 ± 21.35 vs 29.55
± 27.04, p = 0.001). Multivariate linear regression analyses showed statistically significant association
between the type of urinary diversion in favor of orthotopic neobladder regarding the following domains:
cognitive functioning (p = 0.002) and fatigue (p = 0.05).
Discussion
Despite the limitation of the study design, the comparison between the urinary diversion showed an
advantage of the neobladder in terms of HR-QoL. Randomized controlled trials comparing types of urinary
diversion using validated, disease-specific QoL instruments are needed.
Conclusions
Multivariate analyses showed statistically significant association between the type of urinary diversion in
favor of orthotopic neobladder.
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G. Pizzirusso, F. Lanzi, F. Scipioni, N. Tosi, F. Gentile, F. Cecconi, A. Canale, G. De Rubertis, G. Barbanti
(Siena)
Scopo del lavoro
The aim of our study is to investigate functionally and oncologically the role of verumontanum as a
landmark for the complete saving of striated sphincter in patients (pts)undergone radical cystectomy and
ileal orthotopic bladder substitution
Materiali e metodi
We prospectively collected the data of 42 pts undergone radical retropubic cystoprostatectomy plus ileal
orthotopic bladder substitution for clinically localized bladder cancer. We compared the intraoperative
identification and saving of verumontamum and follow-up data determined through urodynamic evaluation.
Clinical, surgical and complete follow-up data were available in 37/42 pts. The urethral sphincteric
mechanism was evaluated with urodynamic study in different positions at a minimum follow-up of 12
months. After that, to compare intraoperative findings every patient underwent uretrocystoscopy to confirm
the presence or absence of verumontanum. Continence was evaluated with ICIQ-SF questionnaire at month
1, 3, 6 and 12
Risultati
Mean follow-up was (range) 21.5 (12-41) months. In 4/37 (10.8%) cases it was found transitional cancer
in bladder trigone ed in 2 of them it was found an unespected presence of tumor in prostatic urethra. In
one case it was discovered a pT2b prostatic carcinoma Gleason 3+3. None of the cases showed a positive
apical surgical margin. Overall, 30/37 (81.1%) pts completely fulfilled our continence criteria (≤1 pad/die
and ICIQ-SF≤2/2/2) in daytime and 24/37 (64.8%) on nighttime at a minimum follow-up of 12 months. In
15/37 (40.5%) pts with verumontanum (Group A)continence was obtained within the first month in 2/15
(13.3%) cases Vs 0/22 in pts without the saving of verumontanum (Group B), 5/15 (33.3%) Vs 5/22 (22.7%)
within the third month,10/15 (66.7%) Vs 13/22 (59%) within the sixth month and in 13/15 (86.7%) Vs 16/22
(72.7%) at a12-months follow-up in Group A and B respectively. The saving of verumontanum resulted
statistically significant in overall continence (p=0.0067) and influential in early recovery of continence (p
Discussione
The recovery of continence in pts with orthotopic neobladder is a crucial functional outcome. In our
experience,the saving of verumontanum during radical cistectomy and ileal orthotopic bladder substitution
improved overall and early continence recovery. The limit of this study is represented by the small number
of both groups and the exiguity of events; our pilot study underlines the need of large,randomized trials to
define the role of verumontanum in overall and early continence recovery
Conclusioni
Verumontanum can be considered an visual intraoperative landmark in saving the maximum of striated
sphincter and, consequently, the maximum of striated sphincter improving overall and early continence
recovery
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CORRELATION BETWEEN METABOLIC PARAMETERS AND RADICAL CYSTECTOMY
COMPLICATIONS: A CLAVIEN CALSSIFICATION SYSTEM-BASED ANALYSIS
DEVELOPMENT OF A QUESTIONNAIRE SPECIFIC FOR PATIENTS WITH ILEAL
ORTHOTOPIC NEOBLADDER (IONB)
F. Cantiello, A. Cicione, R. Autorino, C. De Nunzio, A. Salonia, A. Briganti, G. Gandaglia, P. Dell’Oglio, S.
Perdonà, M. Bevacqua, A. Aliberti, R. Damiano (Catanzaro)
S. Ciciliato, S. Siracusano, C. Lonardi , L. Toffoli, G. Benedetto, P. Curti, M. Cerruto, F. Dal Moro, D.
Signorello, C. Simeone, M. Brausi, F. Visalli, T. Silvestri, M. Niero, I. B. C. G. - QoL (Trieste)
Aim of the study
Despite contiuous significant improvements in surgical technique and perioperative management, Radical
Cystectomy (RC) remains a major operative procedure with significant morbidity and potentially lethal
complications. Little is known on the association between Metabolic Syndrome (MetS), and its single
components, and RC complications. The aim of this cohort study was to test the hypothesis that MetS might
be associated with high grade complications in Bladder Cancer (Bca) patients treated with RC and Urinary
Diversion (UD).
Aim of the study
Ileal orthotopic neobladder (IONB) is often used in patients undergoing radical cystectomy because affected
by invasive bladder cancer. IONB allows to void through the native urethra avoiding to the patients the
disadvantages of an external urinary diversion. However, in these patients with IONB the quality of life
(QoL) appears compromised by the need to urinate voluntarily due to the absence of the proprioceptive
sensitivity at IONB level. In this context, the QoL of these patients can be compromised because they
need to wake up at night interrupting sleep-wake rhythm with important consequences on the social
and emotional life. QoL of patients with IONB is evaluated through the use of generic and not specific
questionnaires. In this way generic QoL questionnaires are useful in studies where IONB patients are
compared with patients with different urinary diversion but they are less effective when only IONB are
evaluated. To answer this problem a specific IONB questionnaire was developed.
We retrospectively analysed 346 patients with bladder cancer undergoing RC with standard
lymphadenectomy, according to the procedure suggested by the International Consultation on Bladder
Cancer ( ICUD-EAU), and urinary diversion. All early complications within 90 days of surgery were
recorded and collected according to the 10 Martin criteria and classified according to the established
five grade of modified Clavien classification system (CCS). MetS was defined according to the National
Cholesterol Educational Program’s Third Adult Treatment Panel. A binary logistic regression analysis were
used to analyze MetS and, separately, its single components, as possible independent risk factors for high
grade complications.
Results
A total of 323 complications occurred in 231 patients (66.8%). The rates for low grade (CCS I-II) and
high grade complications (CCS III-V), as well as mortality within 90 days (CCS V), were 80.8, 19.2 and
1.7%, respectively. At univariate analysis, MetS patients showed a higher rate of high grade complications
compared to without MetS patients (p
Discussion
RC is a surgical procedure with significant morbidity, with 19.2% of high grade complications and 1.7%
of death rate. Patients with MetS present a higher risk of high grade complications. It is fundamental
that urologists recognize and manage MetS for the clinical benefit of their patients. A further and better
knowledge of the metabolic factors that predispose to development of complications is needed to help the
urologists in the selection and counseling of the patients. . Finally, in aging patients with comorbidities, we
believe that a ureterocutaneostomy should be considered to reduce the risk of complications and mortality.
Conclusions
Metabolic syndrome (MetS) and, separately, waist circumference represent independent risk factors for
high-grade complications in BCa patients treated with RC
A) Based on a conceptual framework narrative-based interviews were conducted over 35 patients with
IONB. A basic pool of 43 items was produced and organised throughout 2 clinical and 4 QoL dimensions,
further submitted to 15 IONB patients for face validity testing. B) Psychometric testing was conducted
over 145 IONB patients. Both Classic test strategy (Factor analysis, scaling-reliability measures, step-wise
regression) and Rasch analysis (infit/outfit item analysis) were applied. Psychometric properties (reliability,
construct and discriminant validity) of the resulting scales were comparatively tested against other QoL
validated scales.
Results
IONB questionnaire includes two sections: one on QoL and another one including items on the capability
of the patient to manage the IONB. To measure QoL three versions were delivered: 1) QoL 23-item basic
version (3 domains 23-item; Alpha 0.86÷ 9.69). 2) Short-form QoL 12-item scale (Alpha=947). 3) Shortform 15-item Rasch QoL scale (Alpha= 967). Correlations of long version scales with the corresponding
dimensions of EORTC-QLQ C30 and EORTC-BLM30 resulted significant. Short forms showed significant
correlations with the dimension global health of the EORTC-QLQ C30 and with urinary sub-scales of the
EORTC-BLM30. Effect size was around 1.00 between patients at 1 year follow-up and those with 3, 5 and
>5 years follow-up with all scales. Scales proved also very sensitive in discriminating clusters of patients by
urinary problems and by capability of IONB self-management. No relevant performance differences were
seen between the 12-item short-form and the Rasch scale.
Discussion
This is the first study that proposes a specific questionnaire to evaluate this kind of patients. This
questionnaire that was recently validated seems to be effective and comprehensive.
Conclusions
It would be desirable for a wide use of this questionnaire to evaluate its effectiveness on a large scale of
patients
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DIAGNOSTIC ACCURACY OF 11C-CHOLINE PET/CT COMPARED TO CONTRASTENHANCED CT IN THE POSTOPERATIVE RESTAGING OF RECURRENT BLADDER
CANCER: ANALYSIS OF 20 CONSECUTIVE PATIENTS.
DIAGNOSTIC ACCURACY OF 11C-CHOLINE PET/CT IN COMPARISON WITH CONTRASTENHANCED CT IN THE PREOPERATIVE LYMPH-NODE STAGING OF BLADDER CANCER
USING THE PATHOLOGICAL SPECIMENS AS REFERENCE STANDARD.
V. Vagnoni, R. Schiavina, L. Bianchi, M. Borghesi, C. Pultrone, G. Gentile, M. Cevenini, F. Ceci, M.
Giampaoli, M. Rossi, G. Passaretti, B. Barbieri, S. Fanti, E. Brunocilla, G. Martorana (Bologna)
L. Bianchi, M. Borghesi, V. Vagnoni, C. Pultrone, M. Cevenini, G. Gentile, F. Ceci, M. Giampaoli, F.
Chessa, G. Passaretti, E. Brunocilla, S. Fanti, G. Martorana, R. Schiavina (Bologna, Itali)
Aim of the study
Contrast-enhanced Computed Tomography (CE-CT) and Magnetic Resonance Imaging (MRI) are the
most used diagnostic tools in the detection of bladder cancer (BC) relapses. Recently, 11C-Choline-PET/
CT has been used to stage N and M status in BC patients. The aim of this study was to evaluate the role of
11C-Choline-PET/CT in postoperative restaging of local and distant recurrence in BC patients underwent to
radical cystectomy and ePLND, in comparison with CE-CT, using the pathological specimen as reference
standard.
Aim of the study
Current imaging techniques, such as contrast enhanced computed tomography (CE-CT) and magnetic
resonance imaging (MRI), which provide only morphologic information, demonstrated to be not adequately
accurate in the preoperative nodal staging of bladder cancer (BC). 11C-Choline has been proposed as a
potential tracer for visualization of BC. First clinical trials showed controversial results, even if the series
available in literature are still limited. The aim of this study was to evaluate the role of 11C-Choline-PET/CT
in preoperative evaluation of nodal involvement of BC patients suitable for radical cystectomy and ePLND
in comparison with CE-CT using the pathological specimen as reference standard.
From April 2011 to January 2014, we enrolled 20 patients treated with radical cystectomy and ePLND and
referred to PET/CT for clinical or diagnostic suspicious of relapse during the follow up. 7/20 (35%) patients
received adjuvant Cisplatin-containing chemotherapy. 11C-Choline-PET/CT and CE-CT were used to assess
the presence of local, lymph node and distant recurrence, validating the positive finding by pathological
histology.
Results
The mean age was 72.4±8.4 years. 10 of 20 (20%) patients showed a histologically proven relapse. 3
patients (15%) were positive in the bladder bed: 11C-Choline-PET/CT detected all the local recurrence with
1 false positive (FP) while CE-CT detected only 2 local recurrence with 2 FP. 4 patients (20%) developed
a nodal involvement: 11C-Choline-PET/CT correctly detected 3 of them with 2 FP while CE-CT detected
only 1 patient with nodal recurrence with 4 FP. 3 patients (15%) developed distant metastases (2 in bone and
1 in lung): both 11C-Choline-PET/CT and CE-TC correctly detected the patients with systemic recurrence,
with 1 FP and 3 FP, respectively. Valuating the local recurrence 11C-Choline-PET/CT and CE-CT showed
a sensitivity and a specificity 100% and 66%, 94% and 88%, respectively. Valuating the nodal metastases
11C-Choline-PET/CT and CE-CT showed a sensitivity and a specificity 75% and 25%, 88% and 94%.
Valuating the distant metastases 11C-Choline-PET/CT and CE-CT showed a sensitivity and a specificity
100% and 100%, 94% and 82%, respectively [Table 1].
Discussion
MRI and CE-CT, which provide only morphologic information, have a modest utility in LN-restaging of
BC. 11C-choline-PET/CT and MRI have shown a similar accuracy in the detection of bone lesions in other
urological malignancy: no study have ever compare the two methods in the detection of bone lesions from
BC. One major advantage of 11C-choline-PET/CT is the ability to scan the whole-body in the same exam in
order to detect either local or distant metastasis.
Conclusions
11C-choline-PET/CT proved to be a useful tool in the detection of local, nodal and distant BC relapses. For
this reason, it could become a standard diagnostic procedure in patients at high risk of relapse after radical
cystectomy and ePLND. Further studies are needed in order to evaluate the potential clinical impact of this
diagnostic procedure on recurrent BC patients management.
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78 consecutive patients with histologically proven BC, suitable for radical cystectomy and extended pelvic
lymph node dissection (ePLND), were enrolled from April 2011 to January 2014. In all patients pelvic
lymph nodes were dissected up to the origin of the inferior mesentery artery. The areas of the LN dissection
were grouped as follow: region A included preaaortic and precaval LNs; region B included paravescical,
common, internal and external iliac, obturatory, presacral LNs in the right pelvis; region C included
paravescical, common, internal and external iliac, obturatory, presacral LNs in the left pelvis. 11C-CholinePET/CT and abdominal CE-CT were used to assess the presence of lymph node metastases on a patient-,
region- and LN-based analysis, using results of surgical specimens as diagnostic gold standard.
Results
The mean age was 68.9±9.2 years. 24 of 78 (30%) patients showed nodal metastases at pathological
analysis. Overall, 2350 LNs were evaluated and 154 LNs (6.5%) showed metastatic involvement. Detection
rates and comparisons of 11C-Choline-PET/CT and CE-CT according to the patient-, region- and LN-based
analysis are showed in Table 1. Finally, the detection rate (DR) of 11C-Choline-PET/CT and abdominal CECT were calculated for three different ranges of diameter of the metastatic deposit (10 mm): 11C-CholinePET/CT was superior than CE-CT in all the ranges evaluated and was able to detect nodal metastasis even
with small (<10mm).
Discussion
In BC, lymph node involvement is critical for prognostic and therapeutic reasons. In literature few data are
available about the accuracy of 11C-Choline-PET/CT in BC. In our study, 11C-Choline-PET/CT was more
accurate than CE-CT in the LN evaluation of BC: on patient based analysis and on lymph node analysis
11C-Choline-PET/CT showed a better sensitivity, PPV, NPV than CE-CT.
Conclusions
11C-Choline-PET/CT could provide additional diagnostic information in preoperative nodal staging
of patients with BC in comparison with CE-CT. A study with a larger population should determine if
11C-Choline-PET/CT could be recommended as routine technique in high risk patient with BC.
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LA CISTECTOMIA RADICALE (CR) NEI PAZIENTI OTTUAGENARI: RISULTATI A LUNGO
TERMINE DI DUE CENTRI UROLOGICI
LONG-TERM FOLLOW-UP AND HRQOL IN PATIENTS UNDERGOING RADICAL
CISTECTOMY: STATISTICAL AND CLINICAL ISSUES
M. Brausi, C. Selli, A. Rossi, G. De Luca, G. Peracchia, M. Viola, M. Foresio (CARPI)
S. Siracusano, R. Talamini, S. Ciciliato, L. Toffoli, F. Visalli, M. Cerruto, C. Lonardi, M. Niero, I. B. C. S. QoL (Trieste)
Scopo del lavoro
Gli obiettivi dello studio sono stati : valutare la morbidità, la sopravvivenza globale (OS) e la sopravvivenza
malattia specifica (DSS) nei pazienti ottuagenari sottoposti a cistectomia radicale (CR) in due centri
urologici ad alta casistica operatoria
Materiali e metodi
Dal 2000 al 2012, 1.010 pazienti con TCC vescicale infiltrante o plurirecidivo T1 di alto grado sono stati
sottoposti a CR e derivazione urinaria in 2 Centri Urologici Italiani . 170/1010 pazienti (16,8%) erano di
età maggiore o uguale a 80 anni . L’età media è stata di 83,2 anni: M / F: 128/42. Per la classificazione del
rischio preoperatorio è stato utilizzato l’ASA score. ASA 2: 56/170 (33%), ASA 3: 75/170 (44,1%), ASA 4:
39/170 (23%). 113/170 pazienti (66,5%) hanno avuto come derivazione urinaria l’ uretero-cutaneostomia
(UCS) , 42/170 (25%) pazienti l’ ureteroileocutaneostomia ( Bricker ), in 14/170 pazienti (8,3%) è stata
confezionata una neovescica ortotopica, 1/170 paziente ha avuto l’ ureterosigmoidostomia (0,5%). Stadio
P : T0: 1 paziente (0,5%). Tis + Ta-T1: 25/170 pazienti (14,7%); T2b: 35/170 (20,6%); T3a: 32/170 (19%);
T3b: 45/170 (26,5%); T4: 32/170 (19%). Grado. G3: 153/170 pazienti (90%), G2: 17/170 (10%). In 33 paz.
non è stata effettuata linfoadenectomia pelvica ( CR di salvataggio ). 29/137 paz (21%) erano N + (pT3-T4).
125/170 pazienti (73,5%) sono stati ricoverati in Unità di terapia intensiva per 1-6 giorni. 81/170 pazienti
(47,6%) sono stati trasfusi ( 3,5 U : media trasfusioni ).
Risultati
Il follow-up medio è stato di 44,5 mesi (21-118 mesi). La mortalità perioperatoria è stata del 7,6% (13/170).
Periodo di degenza medio in ospedale è stato di 14,5 giorni (7-35 giorni). La percentuale di complicanze
(mediche e chirurgiche ) è stata del 43%. Nell’ 8,3% dei pazienti ha si è reso necessario il reintervento
chirurgico . Le complicanze mediche e chirurgiche in rapporto all’ ASA sono state: ASA 2 = 11,8%,
ASA 3 = 50% , ASA 4 = 38%. La percentuale di complicanze mediche in base all’ approccio chirurgico
è stata : extraperitoneale = 40,4%, peritoneale = 27%;Percentuale di complicanze chirurgiche : approccio
extraperitoneale = 12,8%, approccio trans-peritoneale = 30% (p
Discussione
Nei paziento ottuagenari sottoposti a cistectomia radicale le complicanze maggiori sono correlate con un
ASA score alto (3-4), il tipo di derivazione urinaria (Bricker) e l’approccio chirurgico (intraperitoneale)
Conclusioni
I risultati del nostro studio supportano l’ indicazione a sottoporre i pazienti anziani con età ≥ 80 anni a
cistectomia radicale. Mortalità e le complicanze sono accettabili
Aim of the study
Patients undergoing urinary radical cystectomy (RC) and urinary diversion for bladder cancer had some
early and late complications with limitations in health-related quality of life (HRQOL). The aim of this
multicentric study was to evaluate differences in HRQOL between patients with bladder cancer undergoing
orthotopic ileal neobladder (IONB) and ileal conduit (IC) after RC and with intermediate-term follow-up.
A total of 319 consecutive patients with bladder cancer (271 males and 48 females) underwent RC from five
urological academic centres with subsequent urinary diversion (171 with IONB and 148 with IC) from June
2007 to September 2012 with no evidence of tumor recurrences and with active follow-up were enrolled
in this study. Clinical and pathological data as well as oncological outcome were retrospectively analyzed
and compared. Quality of life was analyzed using Italian version of the EORTC QLQ-30 and the EORTC
QLQ BLM30 questionnaires. Clinical data and questionnaires results were analyzed in order to evaluate the
HRQOL differences between two diversion groups of patients. As null hypothesis was assumed that there
was no differences between two the urinary diversion groups in terms of HRQOL. Wilcoxon rank test was
used to verify differences between two diversion groups. Statistical significance was achieved if p-value was
≤0.05.
Results
Patients underwent IONB were youngest than IC patients: median age were 66 years (range: 31-83) and
71 (range: 49-95) respectively. There were less females in the group of IONB (8.8%) in comparison with
IC (22.3%). No significant differences were found in the pTNM – UICC stage (stage 0-I were 36.8% for
IONB and 33.8% for IC) and in the median of follow-up (38 months, range: 3-247, and 35 months, range:
4-216) for IONB and IC groups. Patients with IC showed a significant worse in physical functioning
(means: 80.8±22.2 and 74.7±24.8 respectively; p=0.006), in emotional functioning (means: 84.9±20.9 and
78.7±24.7; p=0.02), in cognitive functioning (means: 93.1±12.6 and 85.4±21.2; p=0.0002) in comparison
with IONB. Patients with IC had high level of troubles in fatigue (means: 19.5±21.4 and 29.6±27.0;
p=0.0006), in dyspnea (means: 12.9±22.1 and 20.5±27.1; p=0.007), in appetite loss (means: 6.7±17.2 and
14.2±27.5; p=0.01), in constipation (means: 16.0±21.4 and 31.5±34.7; p
Discussion
Cystectomy with any type of diversion remains a complication-prone surgery, nevertheless our results
showed that IC showed higher troubles than IONB.
Conclusions
This results are in favor of IONB as a the urinary diversion of choice.
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NEOVESCICA ILEALE A “Y” CON L’UTILIZZO DI SUTURATRICI MECCANICHE:
VALUTAZIONE RETROSPETTIVA DEI NOSTRI 243 CASI.
NOSTRA ESPERIENZA NELL’APPLICAZIONE DEL PROTOCOLLO FAST TRACK NEI
PAZIENTI SOTTOPOSTI A CISTECTOMIA RADICALE
C. Ambruosi, O. Maugeri, M. Mediago, F. Venzano, C. Dadone, D. Bernardi, G. Chiapello, E. Galletto, F.
Sommatino, G. Oppezzi, G. Arena (Cuneo)
M. Poggio, I. Morra, C. Fiori, G. Cattaneo, D. Garrou, D. Amparore, M. Manfredi, E. Calza, A. Tempia, F.
Porpiglia (Orbassano)
Scopo del lavoro
In letteratura sono descritti molti interventi per la ricostruzione della neovescica dopo cistoprostatectomia
(Camey 1979 e 1990, Studer 1987, Hautmann 1988, Pagano 1990, Fontana 2004). È noto a tutti che non
esiste un tipo di neovescica migliore rispetto alle altre; anche il concetto “sfericità” della neovescica
sembrerebbe discutibile. Ogni urologo adatta, in base alla propria esperienza ed abitudini il tipo di
neovescica che nelle proprie mani fornisce i migliori risultati. Noi eseguiamo un tipo di neovescica ileale
ortotopica detubularizzata, ricostruita secondo la tecnica a “Y” di Fontana riconfigurata totalmente con
l’utilizzo di suturatrici meccaniche GIA 80.
Scopo del lavoro
Il protocollo “Fast Track” e’ una innovativa modalità di approccio al paziente sottoposto ad intervento
chirurgico, che coinvolge numerose figure specialistiche (oltre al chirurgo e l’ anestesista), atte a garantire
una diminuzione delle complicanze da stress chirurgico, migliorandone il decorso complessivo e riducendo
la durata della degenza. Le differenze rispetto al protocollo standard consistono in: assenza di preparazione
intestinale per os, anestesia combinata (generale+epidurale senza opioidi), rimozione immediata del sondino
nasogastrico, precoce mobilizzazione (2° GPO) e alimentazione (1° GPO) Lo scopo di questo studio e’ stato
di valutare i pazienti sottoposti a cistectomia radicale con derivazione urinaria (neovescica o Bricker ) in
protocollo fast track.
Materiali e metodi
Abbiamo valutato retrospettivamente i nostri 243 pazienti sottoposti derivazione urinaria ileale ortotopica
con la tecnica sopradescritta (da marzo 1999 a marzo 2012). Tutti i pazienti sono stati seguiti presso il nostro
ambulatorio uro-oncologico. Follow-up medio 8 aa (range 2-15). Attualmente risultano in vita 171 pz. Sono
stati valutati gli aspetti intraoperatori, postoperatori, funzionali e le complicanze: continenza, ritenzione di
urina, litiasi nella neovescica, stenosi anostomosi ureterali e uretrali.
Risultati
La durata dell’intervento è stato in media 210’ (180-240), durata media della ricostruzione 52’ (38-67),
giornata di rimozione degli stent ureterali monoJ in 15 (11-18), giornata di rimozione del catetere 22 (1828). Abbiamo documentato 5 casi (2%) di litiasi vescicale, 13 casi (5,3%) di stenosi dell’anastomosi uretero
ileale, 6 casi (2.4%) di stenosi dell’anastomosi uretrale. Continenza diurna nel 91% dei pazienti, 3% di
ritenzione cronica di urina. Nessun caso di deiscenza della sutura sulla neovescica.
Discussione
Nella nostra esperienza la riscostruzione della neovescica ileale a Y è semplice, di rapida esecuzione e
facilmente standardizzabile. Il tasso di complicanze è paragonabile a quello pubblicato in letteratura.
L’incidenza dei calcoli ci sembra trascurabile.
Conclusioni
L’utilizzo di suturatrici meccaniche per il confezionamento della neovescica ileale non espone ad un
aumentato rischio di deiscenza, non altera i risultati funzionali, semplifica la ricostruzione riducendo
sensibilmente i tempi.
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Materiali e metodi
I dati relativi a questo studio sono stati raccolti in modalità prospettica. Sono stati arruolati 80 pazienti
sottoposti a cistectomia radicale con derivazione urinaria (Bricker o neovescica), (16 donne, 64 uomini)
nel periodo compreso tra Gennaio 2011 e Marzo 2014 gestiti nel postoperatorio con protocollo “fast track”
(43 derivazioni sec. Bricker, 27 neovesciche). Di ciascun paziente abbiamo valutato le caratteristiche
demografiche, durata intervento, tempo di canalizzazione a gas e feci, giorno di mobilizzazione e
deambulazione, giorni di ricovero. Le complicanze postoperatorie sono state valutate utilizzando la
classificazione di Clavien.
Risultati
I risultati ottenuti nei due gruppi vengono riportati in tabella 1. Riguardo le complicanze postoperatorie,
stratificate in base alla classificazione di Clavien, nei 43 pazienti in cui è stata confezionata derivazione
urinaria sec Bricker 4 hanno manifestato complicanze di tipo III-V, mentre in quelli con derivazione urinaria
ortotopica 5 hanno manifestato complicanze di tipo III-V.
Discussione
In base ai dati disponibili, la cistectomia radicale risulta una procedura chirurgica in cui il protocollo fast
track non è ancora correntemente applicato.
Conclusioni
Dai dati che emergono dalla nostra casistica risulta comunque una metodica facilmente attuabile con
risultati soddisfacenti negli outcomes postoperatori, in assenza di un evidente incremento delle complicanze
postoperatorie.
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QUALITY OF LIFE OF 171 PATIENTS WITH BLADDER CANCER UNDERGOING ILEAL
ORTHOTOPIC NEOBLADDER: A MULTICENTRE STUDY AMONG LONG-TERM SURVIVORS
TOMOGRAFIA AD EMISSIONE DI POSITRONI CON FLUORO-18 2-FLUORO-2-DESOSSID-GLUCOSIO (FDG-PET/CT) VS TOMOGRAFIA COMPUTERIZZATA (TC) NELLA
STADIAZIONE LINFONODALE PRE-CISTECTOMIA: LA NOSTRA ESPERIENZA
S. Siracusano, S. Ciciliato, R. Talamini, L. Toffoli, F. Visalli, E. Belgrano, I. B. C. S. - QoL (Trieste)
Aim of the study
Patients undergoing urinary radical cystectomy (RC) and urinary diversion for bladder cancer had some
early and late complications, and experience substantial limitations in health-related quality of life
(HRQOL). In the present study, we used the validated Italian version of QLQ-BLM30 from EORTC to
assess bladder cancer-specific HRQOL in patients with ileal orthotopic neobladder (IONB) after RC and
with long term follow-up.
From June 2007 to September 2012, a total of 171 consecutive patients with bladder cancer (156 males
and 15 females), who underwent RC with IONB from five urological academic centres, were included
in this study. Quality of life was analyzed using Italian versions of the EORTC BLM30 questionnaires.
Questionnaire results were analyzed in order to evaluate the HRQOL in patients with IONB at different
times of follow-up (approximately quartiles: 1-18, 19-36, 37-72 and ≥73 months). Mean values with
standard deviations (±SD) were computed for all items. Wilcoxon rank test was used to verify differences by
comparing the short follow-up (1-18 months, first quartile) with subsequent quartiles of follow-up. Statistical
significance was achieved if p-value was ≤0.05 (two-sides).
Results
The median age of the patients was 66 years (range: 31-83). The pTNM–UICC stages were: 36.8% (0-I),
46.2% (II), and 17.0% (II+IV stage). Patients underwent adjuvant chemotherapy were 17 (9.9%) and 10
(5.8%) received radiation therapy of the pelvis. The median of follow-up was 38 months (range: 3-247).
The numbers of patients for each quartile of follow-up were: 43, 42, 35, and 51, respectively for 1-18,
19-36, 37-72, and ≥73 months. Our data showed that patients with a long-term follow-up (≥73 months)
had an improvement in HRQOL in urinary symptoms in comparison with patients with short-term followup (1-18 months) (34.1±23.6 and 18.9±21.1, respectively; p=0.0004) as well as in sexual life (96.9±8.5
and 83.7±25.2, respectively; p=0.005). Conversely we found a worse HRQOL in patients with long-term
follow-up regarding the abdominal bloating and flatulence (8.9±22.2 and 17.6±20.9, respectively; p=0.003).
In addition in patients with an intermediate follow-up (37-72 months) we found a poor HRQOL in body
image (23.8±27.6 and 35.6±27.5, respectively; p=0.02), and sexual functioning (13.8±23.8 and 21.9±24.5,
respectively; p=0.04).
Discussion
Based on the result of the present study, RC and IONB have a negative impact on HRQOL. Body image
and sexual functioning are a more significant problems in intermediate follow-up. Patients with a long-term
follow-up had an improvement in HRQOL in urinary symptoms in comparison with patients with shortterm follow-up. We found a worse HRQOL in patients with long-term follow-up regarding the abdominal
bloating and flatulence
A. Buffardi, A. Parente, A. Battaglia, P. Destefanis, M. Bellò, P. Gontero, G. Bisi, B. Frea (Torino)
Scopo del lavoro
Nei pazienti affetti da neoplasia vescicale muscolo-invasiva o con neoplasia non-muscolo invasiva ad alto
rischio ricorrente e refrattaria al BCG, il trattamento è rappresentato dalla cistectomia radicale. In questi
pazienti, la presenza di metastasi linfonodali rappresenta un importante fattore prognostico. La metodica
di imaging impiegata nella stadiazione preoperatoria di tali neoplasie è rappresentata dalla tomografia
computerizzata con mezzo di contrasto (TC), che possiede un’accuratezza (in termini di sensibilità e
specificità) del 70-90% per quanto concerne l’individuazione di metastasi linfonodali. La tomografia ad
emissione di positroni con Fluoro-18 2-fluoro-2-desossi-D-glucosio (18F-FDG-PET/CT) è una metodica
impiegata per diverse neoplasie, ma non ancora validata per lo staging delle neoplasie vescicali. Scopo del
presente lavoro è valutare il possibile ruolo della PET/CT nello staging linfonodale pre-cistectomia.
Materiali e metodi
Tra Ottobre 2012 e Aprile 2014 sono stati stadiati sia con una TC che con una PET/CT 40 pazienti prima
della cistectomia radicale. Tutti i pazienti sono stati sottposti ad una linfadenectomia pelvica standard in
corso di cistectomia; la linfadenectomia è stata allargata a livello retroperitoneale nei casi dubbi alla PET/
CT e/o alla TC. I risultati delle indagini di imaging sono stati infine confrontati con l’esame istologico
definitivo. Dati completi sono disponibili per 33 pazienti.
Risultati
In 8 pazienti la FDG-PET/CT è risultata sospetta per metastasi linfonodali, tutti confermati all’esame
istologico (2 casi pN3, 4 pN2, 2 pN1). Solo in un caso la PET/CT ha dato esito negativo, mentre il paziente
è risultato pN1 all’istologia. La sensibilità della PET/CT nella stadiazione linfonodale è risultata essere,
nel nostro campione, dell’89%, la specificità del 100%. La TC è risultata essere sospetta per metastasi
linfonodali in 3 casi, 2 dei quali confermati all’istologia. La sensibilità della TC nella stadiazione linfonodale
è risultata essere, nel nostro campione, del 22%, mentre la specificità del 96%. Inoltre la PET/CT ha
evidenziato 4 pazienti con secondarietà a distanza (M1), comunque operati con intento palliativo.
Discussione
Sia la TC che la PET/CT sono risultate essere due metodiche di imaging con elevata specificità, ma, per
quanto concerne la stadiazione linfonodale, la PET/CT si è dimostrata di gran lunga più sensibile, in quanto
riesce ad indentificare metastasi linfonodali anche di dimensioni intorno ad 1 cm, morfologicamente non
valutabili alla TC.
Conclusioni
In base ai nostri risultati, la PET/CT è risultata maggiomente utile rispetto alla TC nella stadiazione
linfonodale preoperatoria. Il limite più grande nell’impiego di tale metodica nello staging preoperatorio dei
pazienti con neoplasia vescicale è rappresentato attualmente dai costi.
Conclusions
: Our study based on long-term follow-up in patients undergoing RC with IONB showed some improvement
in HRQOL with regards to the role of urinary symptoms, sexual life.
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AKT ACTIVATION IS INVOLVED IN OLEATE-INDUCED DOCETAXEL RESISTANCE IN
ANDROGEN-INDEPENDENT PROSTATE CANCER CELLS
CXCR4 INHIBITION REDUCES BONE METASTASES BY AFFECTING TUMOUR GROWTH
AND TUMORIGENIC POTENTIAL IN PROSTATE CANCER PRECLINICAL MODELS.
D. Terracciano, V. Cosimato, A. Marino, E. Giorgio, V. Altieri, A. Cioffi, D. Matei, D. Bottero, G. Musi, M.
Capece, O. de Cobelli, V. Mirone, M. Ferro (napoli)
G. Gravina, A. Mancini, L. Ventura, L. Scarsella, A. Jitariuc, A. Colapietro, E. Ricevuto, S. Lonning, E. Di
Cesare, C. Festuccia (L’Aquila)
Aim of the study
Epidemiological studies suggest an association between dietary fat intake, prostate cancer (PCa) risk
and worse prognosis. A common finding has been that the essential polyunsaturated fatty acids (PUFAs),
omega-6 and omega-3, are associated with increased and reduced prostate cancer risk, respectively.
Recently, Hagen et al showed that fatty acid treatments of PCa cells can have a pro- or anti-proliferative
effect in a cell-line dependent manner. However, less is known about the molecular mechanisms regulating
the effects of specific unsaturated and saturated fatty acids on prostate cancer cell. Hardy et al showed
that oleate binds to G protein-coupled receptor GPR40 resulting in the activation of Src proteins, PI3K/
Akt and Ca2+ signaling, thus promoting cell growth in breast cancer cells. Moreover, Liu et al showed that
oleate (OLA) is associated with the development of renal cell carcinoma via activation of GPR40/ILK/Akt
pathway. Therefore, we speculated that OLA modulate PCa cell proliferation and response to Docetaxel
(DCTX) and that these effects may be mediated by GPR40/Akt pathway.
Aim of the study
The majority of prostate cancer (PCa) patient morbidity can be attributed to bone metastases posing a
significant clinical obstacle. Therefore, a better understanding of this phenomenon is imperative and might
help to develop novel therapeutic strategies.I woul like to study the expression of CXCR4 in human prostate
cancer patients and its role in bone metastases.
We incubated PC3 androgen-independent cell lines with OLA 200µM alone and in combination with DCTX
(first-line therapy in androgen-indipendent PCa) for 48 h. We evaluated cell viability and drug response by
MTT assay. GPR40 expression has been analyzed by RT-PCR and Akt phosphorylation by immunoblotting
analysis.
Results
We showed that OLA increased PC3 cell viability. Combined treatment (OLA+ DCTX) showed a reduced
PC3 Drug Response and an increased Akt activation. Of note, these biological effects were reverted
incubating the cells in presence of the PI3K/Akt inhibitor LY294002.
Discussion
This area of research is interesting as revealing that metabolic pathways may broaden therapeutic options
for PCa treatment. Moreover, the role of oleate as an extracellular signaling molecule in cancer cell may
represent a potential link between obesity and cancer.
Conclusions
These findings suggested that OLA induced PC3 proliferation and AKT activation and it could be a key
player in the metabolic mechanisms regulating PCa cell malignant phenotype. Moreover, OLA induced
GPR40 expression and the pathway OLA/GPR40/Akt may represent a potential link between diet, obesity
and cancer.
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We analyzed the expression of CXCR4 in human tissues from prostate cancers, and tested in vitro and in
vivo the capabilities of two CXCR4 receptor antagonists, Plerixafor and CTE9908 to interfere with bone
metastasis.
Results
Bone-derived PCa cells expressed higher CXCR4 levels than other PCa cell lines; this was also the case
in human samples. SDF-1α induced tumor cell migration, invasion and protease expression. CXCR4
antagonists reduced PCa cell proliferation and was more effective when PCa were co-cultured with stromal
cells, possibly due to the high levels of SDF-1α expressed by stromal cells. Plerixafor and CTCE-9908
delayed tumor growth, reduced angiogenesis and incidence of X-ray detectable bone lesions. Boneassociated tumor growth and associated bone erosion were, indeed, efficiently decreased by CXCR4
antagonist treatment with respect to controls. Kaplan-Meier analyses showed significantly improved overall
survival after treatments. The reduced intra-osseous growth of PC3 tumor cells after intratibial injection
correlated with decreased osteolysis and serum levels of both mTRAP and type I collagen fragments (CTX).
Discussion
Although a growing body of evidence has demonstrated that CXCR4 plays an important role in cancer
proliferation, dissemination and invasion and our results seem seem to confirm the role of CXCR4 in bone
metastasis formation. Our report is the first in which CXCR4 antagonists have been tested to discern whether
the number of tumour cells within bone marrow (intraosseous tumour burden) was a variable related to their
effectiveness.
Conclusions
In summary, our report provides novel information on the potential activity of CXCR4 inhibitors on the
formation and progression of prostate cancer bone metastases and supports this treatment as a useful
approach in men with advanced PCa with established metastatic disease or at high risk of bone lesions.
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FINGERPRINTING OF ULTRACONSERVED GENOMIC REGIONS(UCRS) IN BLADDER
CANCER
METABOLIC PATHWAYS IN CLEAR CELL RENAL CELL CARCINOMA: POSSIBLE
THERAPEUTIC TARGETS
M. Olivieri, M. Durso, S. Terreri, F. Febbraio, D. Bottero, D. Matei, G. Musi, M. Capece, V. Mirone, O. de
Cobelli, M. Ferro, D. Terracciano, A. Cimmino (Napoli)
C. Bianchi, C. Meregalli, V. Di Stefano, E. Cattaneo, B. Torsello, S. Bombelli, G. Bovo, P. Viganò, G.
Strada, R. Perego (Monza)
Aim of the study
Urothelial carcinoma is the most common form of cancer in the bladder and can be divided into two groups
defined by their distinct behaviors and different molecular profiles. These groups are characterized as lowgrade tumors, which are always papillary and usually superficial, and high-grade tumors, which can be either
papillary or nonpapillary and often invasive. Recently, thousands of long non-coding RNA (lncRNAs) have
been identified and disease-associated lncRNA profiles, obtained with a variety of molecular approaches,
have placed lncRNAs on the stage of integrated cancer biology. Functional studies have indicated that
some lncRNAs are involved in human bladder cancer pathogenesis, acting as either oncogenes or tumor
suppressors. In our previous study has been demonstrated that a new class of lncRNAs, called transcribed
ultraconserved regions (T-UCRs), is consistently deregulated in several human tumors.
Aim of the study
Clear cell Renal Cell Carcinoma (ccRCC) is characterized by cells filled with lipid and glycogen. The biallelic inactivation of VHL gene prevents degradation of HIF1a and HIF2a that activate specific hypoxiainducible genes, involved in the development of metabolic alterations responsible of the “clear” cytoplasm.
The activation of glycolysis and lactate production even in the presence of oxygen, the alteration of
mitochondrial oxidative metabolism, and the switch of glutamine metabolism that supply Krebs cycle to
support lipogenesis, are present in ccRCC and can be potential therapeutic targets. Interestingly, PPAR
pathway, involved in fatty acid metabolism, seems to be negatively regulated by Annexin A3 protein [J
Biochem 2012, 152, 355] that we have previously evidenced as downregulated in RCCcc cells [Am J Pathol
2010, 176, 1660]. Our aim was to investigate whether: 1) lipid and glycogen storages were differently
modulated on the basis of histopathological features; 2) the viability of ccRCC cells were differently affected
by specific metabolic pathway inhibition; 3) Annexin A3 was involved in lipid storage of ccRCC cells.
In order to assess whether T-UCRs can be detected and are differentially expressed in bladder cancer
tissues (n=24) compared to the control (n=4), total RNA was extracted from each sample, and hybridized
with version 4.0 of Dr. Croce’s ncRNA microarray, that includes probes which are able to detect T-UCR
transcripts both in sense, and antisense (A) orientation.
Results
By using genome-wide profiling, we found that T-UCRs are de-regulated in bladder cancer, and some of
them are able to enhance cell motility and growth in vitro by influencing the expression of motility-related
genes. We obtained a specific signatures of de-regulated T-UCRs listed in fig.1 .
Discussion
Based on the ability of RNA stems to form complexes with other nucleic acids and to be rapidly transcribed
and degraded, we have demonstrate an extensive and dynamic regulatory network of the RNA signaling
associated with cancer progression. In particular, we define a model that explains the effect of single T-UCR
perturbation on whole T-UCRs network of interactions and demonstrate the function of T-UCRs as natural
miRNA decoys in the development of bladder cancer.
Conclusions
the discovery of ultraconserved ncRNA as regulatore of microRNA indicate also how conserved is this
mechanism during evolution and opens up the possibility of a new biological mechanism that could be
targeted by oligonucleotide gene therapy.
Primary cell cultures established from ccRCC of different Fuhrman grade and normal cortex tissue were
used. Lipid and glycogen storages were evaluated in cultures and corresponding tissues by Oil Red “O” and
PAS staining. MTT assay was used to analyze the viability of primary cell cultures after 72 h of treatment
with specific inhibitors of lipid (etomoxir) or glucose (2DG) metabolism, and after culture in glutamine
depleted media.
Results
The lipid storages were more abundant in lower grade (G2) than in higher grade (G3-G4) ccRCC primary
cultures and corresponding tissues. The glycogen storages were more abundant in higher grade (G3-G4)
ccRCC cultures and tissues. The viability of low grade (G2) ccRCC cultures was affected by treatments that
interfered with lipid metabolism (etomoxir and glutamine depletion). Higher grade (G3) ccRCC cultures
were affected by treatments that interfered with glucose metabolism (2DG). Also transcriptomic and miRNA
profiles of our ccRCC primary cultures were consistent with the cytological phenotype. Annexin A3 gene,
silenced by siRNA, induced in ccRCC cell an increase of lipid storage with a decrease of cell viability.
Discussion
The data evidenced different metabolic storages in ccRCC cells and different impact of glucose and lipid
metabolism on cell viability, in relation to histopathological grading of corresponding tumor tissues. The
involvement of Annexin A3 protein in modulation of lipid storage in ccRCC cells may shed light on the
molecular mechanisms involved in metabolic reprogramming of ccRCC.
Conclusions
These results can be useful to develop an approach to “personalized medicine” for ccRCC, targeting
metabolic pathways highly represented in specific ccRCC grades.
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MICRORNA E KALLIKREINE SIERICHE PRIMA E DOPO PROSTATECTOMIA RADICALE
RUOLO DELLE TREG CD8+ NEI TUMORI DI RENE E VESCICA
G. Cochetti, M. Egidi, E. Cottini, F. Barillaro, A. Boni, E. Mearini (Terni)
P. Traverso, A. Parodi, F. Minaglia, F. Kalli, G. Conteduca, D. Fenoglio, A. Simonato, G. Carmignani, G.
Filaci (Genova)
Scopo del lavoro
Scopo primario dello studio è stato valutare la correlazione specifica tra il carcinoma prostatico (CaP) e i
livelli di espressione nel siero di 3 Kallikreine (KLK) (KLK3/PSA, KLK11 e KLK13) e 2 microRNA (miR21, miR-141). L’obiettivo secondario è stato valutare il loro potere diagnostico.
Materiali e metodi
38 pazienti, affetti da CaP organo-confinato e sottoposti a prostatectomia radicale, sono stati arruolati
consecutivamente dal Settembre 2011 all’Aprile 2012. Sono stati poi selezionati 40 controlli sani. I livelli
di espressione nel siero di miR-21 e miR-141 sono stati valutati quantitativamente utilizzando la PCR realtime e miR-93 è stato scelto come reference gene. Negli stessi campioni di siero sono stati quantificati
i livelli di espressione di KLK3, KLK11 e KLK13 con test ELISA. Nei pazienti affetti da CaP, i livelli
sierici dei microRNA e delle KLK sono stati valutati in 4 momenti: 1 giorno prima dell’intervento (T0)
e in 1a (T1), 5a (T2), e 30a (T3) giornata postoperatoria. Abbiamo valutato la correlazione specifica tra
il CaP e KLK3, KLK11, KLK13, miR-21 e miR-141, confrontando i loro livelli di espressione nel siero
prima dell’intervento e dopo (T1, T2, T3). L’accuratezza diagnostica di miR-21, miR-141, KLK3, KLK11 e
KLK13 sono state studiate attraverso l’analisi delle curve ROC (Receiver Operating Characteristic.
Risultati
I livelli sierici di KLK11 e KLK13 si sono ridotti in maniera statisticamente significativa dopo l’intervento,
sebbene al tempo T2 e T3 non si sono azzerati come il PSA. I livelli sierici di KLK11 e KLK13 al tempo
T0 erano significativamente più elevati (p< 0.01 e p< 0.001,rispettivamente), probabilmente a causa di
una sintesi de novo dei microRNA indotta da una reazione infiammatoria sistemica. I livelli sierici dei
microRNA al tempo T3 non erano significativamente differenti dai livelli preoperatori (T0=T3,p>0.05).
Non è risultata alcuna differenza statisticamente significativa tra i livelli sierici preoperatori di miR-21 dei
pazienti con CaP e quelli dei controlli sani (p>0.05). Al contrario i livelli sierici preoperatori di miR-141
nei CaP erano significativamente inferiori rispetto a quelli nei controlli sani (p0.05), mentre miR-141 ha
presentato una AUC di 0.811 (p< 0.0001), seguito da KLK11 (AUC=0.994, p< 0.0001).
Scopo del lavoro
Uno dei meccanismi descritti legati alla soppressione immunitaria tumore associata in certe neoplasie
potrebbe essere la espressione aberrante di molecole inibitrici le cellule T che sono deputate a mediare
la risposta immunitaria antitumorale . Purtroppo, ancora poco si conosce sui linfociti infiltranti i tumori
(TILs) vescicali. Lo scopo della ricerca è stato il confronto a livello molecolare e fenotipico dell’infiltrato
linfocitario derivato da TCC della vescica e del RCC del Rene, rispetto a tessuto sano ed al comparto
linfocitario periferico, nonché le possibili correlazioni.
Materiali e metodi
Abbiamo campionato in 21 casi (10 RCC 11 TCC) : a -il prelievo di sangue periferico eparinato, b - un
campione del tessuto neoplastico c- un campione dello stesso distretto non macroscopicamente affetto da
malattia. Tutte le frazioni sono state processate per la valutazione delle popolazioni linfocitarie T regolatorie
(Treg) sia CD4+ sia CD8+ mediante citometria a flusso e dell’espressione di Mage (Antigene Tumore
Associato) 1, 2 e 3 con approccio molecolare. I dati fenotipici e molecolari ottenuti sono stati correlati con lo
stadio di malattia TNM.
Discussione
I risultati ottenuti necessitano di ulteriori studi su ampia scala per poter essere confermati.
Risultati
Le analisi fenotipiche indicano che: a) la frequenza della popolazione CD8+ Treg nel sangue periferico è
statisticamente superiore nei pazienti con tumore di rene e vescica rispetto ai donatori sani; b) il confronto
dell’infiltrato linfocitario tumorale ed i linfociti nel tessuto sano nei due tipi di neoplasia, ha evidenziato una
presenza statisticamente superiore di cellule CD8+ Treg nell’infiltrato tumorale del rene rispetto al tessuto
sano, mentre nei campioni derivati dalla vescica le CD8+ Treg sono risultate elevate in entrambi i campioni
c) la componente CD4+ Treg infiltrante il tumore è statisticamente superiore rispetto al tessuto sano in
entrambe le neoplasie; d) le frequenze delle cellule CD4+Treg circolanti risultano inferiori nel distretto
periferico dei pazienti con neoplasia renale rispetto ai pazienti con neoplasia vescicale, ma senza differenze
in entrambi i casi statisticamente significative rispetto ai sani. Le analisi molecolari hanno evidenziato una
differenza statisticamente significativa per l’espressione di Mage tra tessuto tumorale e sano, sia nel rene sia
nella vescica. La correlazione dello stadio TNM con le frequenze delle cellule CD8+Treg intratumorali, ha
indicato una relazione positiva tra stadio e presenza di Treg.
Conclusioni
KLK11 e KLK13 hanno mostrato una specifica correlazione con il CaP. KLK13 ha dimostrato la migliore
accuratezza diagnostica, seguita da KLK11 e miR-141. MiR-21 non si è dimostrato un accurato marcatore
diagnostico per il carcinoma prostatico organo-confinato.
Discussione
I dati fenotipici e le analisi statistiche sembrano suggerire un ruolo critico delle cellule CD8+ Treg nella
porzione non macroscopicamente affetta da malattia, nel favorire una maggiore probabilità di recidiva nel
tumore della vescica rispetto al tumore di rene.
Conclusioni
Il tumore renale ed quello vescicale nella nostra casistica risultano diversi nella componente linfocitaria T
dell’infiltrato: tale dato che potrebbe giustificare il diverso decorso clinico e la la peculiare storia naturale del
tumore vescicale, ponendo le basi per un indicatore prognostico clinico.
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SERUM TESTOSTERONE REDUCTION DURING TARGETED THERAPIES FOR MRCC
TUMOR VEGF EXPRESSION CORRELATES WITH TUMOR STAGE AND IDENTIFIES
PROGNOSTICALLY DIFFERENT GROUPS IN CLEAR CELL RENAL CELL CARCINOMA
PATIENTS
A. Mosca, C. Porta, G. Martignoni, V. Ficarra, S. Andorno, G. Aimaretti, O. Alabiso, C. Terrone (Novara)
Scopo del lavoro
The primary objective of this study was to assess the variations of serum testosterone (TST), sexual
hormone-binding globulin (SHBG) and thyroid-stimulating hormone (TSH) during targeted therapies in
mRCC male pts. The secondary objective was to observe androgen, estrogen and progesterone receptor
expression in tissue specimens derived from radical nephrectomies (RN).
Materiali e metodi
We prospectively evaluated serum levels of TST, SHBG and TSH, at baseline and after 1 and 2 months of
therapy, in 43 consecutive male pts with mRCC (89% clear cell, 9% papillary, 2% mixed), submitted to
Sunitinib (63%), Pazopanib (7%), Sorafenib (16%) and Everolimus (14%), as I line (81%), II line (14%)
and III line (5%) treatment. Furthermore, we retrospectively assessed androgen, estrogen and progesterone
receptors in 64 tissue microarray specimens of pts submitted to RN.
Risultati
After 1 and 2 months of therapy, TST significantly decreased (mean values: baseline 316.83 ng/dl; after 1
month 250.82 ng/dl; after 2 months 262.81 ng/dl; p=0.017); SHBG significantly increased (mean values:
baseline 30.88 mmol/l; after 1 month 37.41 mmol/l; after 2 months 40.61 mmol/l; p=0.0007); and, as
expected, TSH significantly increased (mean Log values: baseline 0.82 μUI/ml; after 1 month 1.10 μUI/ml;
after 2 months 1.31 μUI/ml; p=0.0052). Immunoistochemical analysis of RN revealed androgen receptors in
12/64 (19%) of specimens, progesterone receptors in 1/64 (0.6%) of tissues and no expression of estrogen
receptors (0%).
Discussione
Several antiangiogenic therapies have been recently approved for metastatic renal cell carcinoma (mRCC),
targeting the vascular endothelial growth factor axis or the mammalian target of rapamycin pathway.
Efficacy of these agents is largely demonstrated, but toxicity profile may lack of exhaustive clinical
data. Fatigue is experienced up to 77% of patients (pts) receiving antiangiogenic agents. Hypogonadism
contributes to frequent symptoms in cancer pts, including fatigue, anorexia, depression, and sexual
dysfunction. We demonstrate a significant decrease in serum testosterone level during targeted therapies that
could affect quality of life of the patients.
Conclusioni
Sunitinib, Pazopanib, Sorafenib, Everolimus caused a statistical significant suppression of TST levels, with
simultaneous offsetting increase of SHBG, in male pts treated for mRCC. The hypogonadism secondary
to antiangiogenic treatment may contribute to fatigue often described by pts as a serious adverse event.
Androgen receptors expression in RN has to be carefully evaluated when TST replacement is considered.
D. Minardi, M. Santoni , G. Lucarini, R. Mazzucchelli, L. Burattini, A. Conti, M. Bianconi, M. Scartozzi, R.
Di Primio, R. Montironi, S. Cascinu, G. Muzzonigro (Ancona)
Aim of the study
Vascular endothelial growth factor (VEGF) is a potent inducer of tumor angiogenesis and represents the key
element in the pathogenesis of clear cell renal cell carcinoma (ccRCC). Aim of this study was to investigate
the use of tumor VEGF expression as a parameter to identify tumour stage and prognostically different
patient groups.
We retrospectively collected clinical data of patients treated with partial or radical nephrectomy at our
institutions for organ–confined, locally advanced and metastatic ccRCC between 1984 and 2013. Tumor cell
VEGF immunohistochemical expression was compared with pathological and clinical features including
age, sex, tumor stage and Fuhrman grade. Comparison of VEGF expression levels between tumor stages
was performed via Kruskal-Wallis non-parametric test. Survival analysis was conducted via Kaplan-Meier
product-limit method and Mantel-Haenszel log-rank test was employed to compare survival among groups.
Results
Median age at diagnosis was 61 years (range 33-85 years). Tumor stage was pT1N0M0 in 67 patients
(49%), pT2N0M0 in 5 (4%), pT3N0M0 in 25 (18%), while 40 patients (29%) were metastatic at diagnosis.
Fuhrman nuclear grade was G1 in 22 patients (16%), G2 in 60 (44%), G3 in 33 (24%), G4 in 13 patients
(9%) and unknown in 9 patients. Tumor-VEGF was differentially expressed among different stages (p <
0.001) and comparing low (G1-2) with high Fuhrman grades (G3-4) tumors (p < 0.001). No significant
differences were found when stratifying by sex (p = 0.06) or age (p = 0.29). Median overall survival (OS)
from partial or radical nephrectomy was 161 months. We observed a significantly longer OS in patients with
low (25%) VEGF expression (median OS 206 vs 65 months, p < 0.001).
Discussion
Prognostic stratification should be considered a major step forward for the management of ccRCC patients.
Our analysis showed that tumor-VEGF was expressed in different pattern among different stages and
different Fuhrman grades, thus confirming that VEGF expression is associated with higher tumor stage and
grade and malignant potential. Our current study shows that VEGF expression exhibits a complex pattern
of coordinated expression in RCC; our observations were made in an untreated patient population, and it
could be possible that they may have significant therapeutic implications in the selection of patients who
will benefit from adjuvant antiangiogenic therapies. Grouping the tumors on the basis of VEGF expression
in tissue components may provide a prognostic tool and might also provide a mean for determining which
tumors will be best treated with adjuvant antiangiogenic therapies after conservative or radical surgery,
independently from the tumor stage.
Conclusions
Our data show that tumor cell VEGF expression is significantly associated with tumor stage and Fuhrman
grade, and is able to predict patients outcome, suggesting a potential use of this parameter in identifying
prognostically different ccRCC patients.
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XPO1/CRM1-SELECTIVE INHIBITORS OF NUCLEAR EXPORT (SINE) REDUCE TUMOR
SPREADING AND IMPROVE OVERALL SURVIVAL IN PRECLINICAL MODELS OF
PROSTATE CANCER (PCA).
10-YEAR EXPERIENCE WITH ORAL ETHINYLESTRADIOL IN CASTRATION RESISTANT
PROSTATE CANCER
G. Gravina, M. Tortoreto, A. Mancini, A. Addis, E. Di Cesare, Y. Landesman, D. McCauley, M. Kauffman,
S. Shacham, N. Zaffaroni, C. Festuccia (L’aquila)
Aim of the study
Exportin 1 (XPO1) is the sole exportin mediating transport of many multiple tumor suppressor proteins
(TSP) out of the nucleus. Tumor microenvironment promote cell activation and proliferation and resistance
to spontaneous and drug-mediated apoptosis. Many of these microenvironment-activated pathways intersect
with TSPs which are exported from the nucleus by XPO1, leading to their functional inactivation. XPO1
inhibition leads to CRM1 nuclear localization with forced accumulation of TSPs determining reduced
oncogenic functions. Thus, the concept of inhibiting XPO1 has been explored as a potential therapeutic
intervention using clinically relevant orally bioavailable compounds.
In this report we used: (i) orthotopic intra-prostate model, to study the anti-metastatic effects of KPT330 and
KPT251; (ii) intra-ventricular model to mimic an aggressive prostate cancer with no evident bone metastasis
and (iii) intratibial injection to study the intra-bone tumor growth.
Results
In vitro, Selinexor reduced both secretion of proteases and ability to migrate and invade of PCa cells.
SINEs impaired secretion of pro-angiogenic and pro-osteolytic cytokines and reduced osteoclastogenesis in
RAW264.7 cells. In the intra-prostatic growth model, Selinexor reduced DU145 tumor growth by 41% and
61% at the doses of 4 mg/Kg qd/5 days and 10 mg/Kg q2dx3 weeks, respectively, as well as the incidence of
macroscopic visceral metastases. In a systemic metastasis model, following intracardiac injection of PCb2
cells, 80% (8/10) of controls, 10% (1/10) Selinexor- and 20% (2/10) KPT-251-treated animals developed
radiographic evidence of lytic bone lesions. Similarly, after intra-tibial injection, the lytic areas were higher
in controls than in Selinexor and KPT-251 groups. Analogously, the serum levels of osteoclast markers
(mTRAP and type I collagen fragment, CTX), were significantly higher in controls than in Selinexor- and
KPT-251-treated animals. Importantly, overall survival and disease-free survival were significantly higher in
Selinexor- and KPT-251-treated animals when compared to controls.
Discussion
To our knowledge, this manuscript is the first report showing that SINE XPO1-antagonists show antimetastatic properties. Our data suggest that SINE compounds, and Selinexor in particular, could achieve
these effects through several mechanisms: (i) inhibiting the survival and inducing apoptosis of circulating
metastasizing cells; (ii) reducing the migration and the invasion of metastasizing cells; (iii) reducing bone
colonization by metastatic cells; (iv) reducing the tumor burden both in the primary and in bone sites; (v)
reducing the survival and probably differentiation of osteoclast progenitors.
Conclusions
Selective blockade of XPO1-dependent nuclear export represents a completely novel approach for the
treatment of advanced and metastatic PCa.
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S. Salciccia, A. Sciarra, S. Cattarino, A. Gentilucci, M. Innocenti, F. Minisola, G. D’Eramo, V. Gentile
(Roma)
Scopo del lavoro
To describe our 10-year experience with the use of oral ethinylestradiol in the treatment of metastatic CRPC
(mCRPC)cases.
Materiali e metodi
From February 2000 to April 2010, 116 cases with a metastatic CRPC were prospectively submitted to oral
ethinylestradiol monotherapy . Inclusion criteria were represented by : diagnosis of CRPC after failure at
least of two lines of androgen deprivation therapy;radiological evidence of metastases. Exclusion criteria
were represented by: symptomatic cases with an European Cooperative Oncology Group (ECOG) score > 2;
severe or uncontrolled cardiovascular diseases . At inclusion in the study, all cases discontinued the previous
androgen deprivation therapy and started oral ethinylestradiol at the daily dose of 1 mg. Aspirin (100 mg/
daily) was concomitantly given
Risultati
The median ethinylestradiol therapy duration was 15.9 months (range 8 - 36 months), whereas the median
follow-up of patients was 28 months (range 13 - 36 month) . During ethinylestradiol therapy a conformed
PSA response was found in 79 cases (70.5%). The median time to PSA progression was 15.10 months (95%
C I 13.24 - 18.76 months). The oral administration of ethinylestradiol monotherapy was associated with a
very high PSA response rate (70.5%) and a high percentage (21.4%) of cases with an initial “normalization”
(< 4 ng/ml) of PSA levels. Therefore our study sustains that a high percentage of CRPC cases initially
responds to ethinylestradiol therapy. The second point is the duration of this positive response. We found
that the proportion of mCRPC cases without a PSA progression at 12 and 24 months was 64.3% and
7.1 % respectively and the median time for PSA progression was 15 months. Considering the oncologic
characteristics of our population (CRPC metastatic cases), ethinylestradiol was able to produce a significant
time in which patients were free from PC progression. Results in terms of survival sustain these data. The
response to ethinylestradiol therapy was also associated to an improvement (48.1%) or stabilization (51.9%)
in the performance status of the patients. A toxicity that required treatment cessation was described in 26
cases (23.2%) at a median time of 16 months (mainly thromboembolism ).
Discussione
Recently there has been a renewed interest in using estrogens. On the other hand, it is also true that
the development of new significant treatment strategies for CRPC limits the use of an old therapy such
estrogens.
Conclusioni
In the present 10-year experience on mCRPC cases, the use of ethinylestradiol showed a positive therapeutic
effect, either in terms of PSA response or as survival. Possible cardiovascular toxicity can be managed
through an accurate patient selection and follow-up and a concomitant anticoagulation therapy.
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P 174
CAN WE CONSIDER PATIENTS WITH LIMITED BIOPSY GLEASON SCORE 3+4 ELIGIBLE
FOR ACTIVE SURVEILLANCE?
EFFECTS OF PRIOR USE OF STATINS IN A PHASE 3 STUDY OF INTERMITTENT VERSUS
CONTINUOS COMBINED ANDROGEN DEPRIVATION
E. Zaffuto, G. Gandaglia, N. Suardi, U. Capitanio, E. Di Trapani, M. Moschini, D. Vizziello, A. Salonia, V.
Scattoni, F. Montorsi, A. Briganti (Milano)
M. Brausi, M. Viola, F. Calais Da Silva, F. Calais Da Silva (Carpi)
Aim of the study
Several authors proposed different eligibility criteria for active surveillance (AS) in patients with lowrisk prostate cancer (PCa). However, virtually all excluded patients with biopsy Gleason score 3+4. We
hypothesized that, in active surveillance candidates, limited biopsy Gleason score 3+4 at extended biopsy
sampling does not substantially increase the risk of unfavorable disease at final pathology.
The study included 330 patients who could have been selected for active surveillance according to the
PRIAS criteria (namely, PSA≤10 ng/ml, PSA density
Results
Mean patient age was 64.4 years (median: 65). Mean and median number of cores taken was 15.8 and
14, respectively (10-24). Within the PRIAS candidates, 6 (1.8%), 19 (5.7%), 5 (1.5%), and 4 (1.2%) had
pathological Gleason score 8-10, extracapsular extension, seminal vesicle invasion, and lymph node
invasion, respectively. When patients with biopsy Gleason score 3+4 who fulfilled all the other active
surveillance criteria were included, 8 (2.2%), 22 (5.9%), 7 (1.9%), and 6 (1.6%) had pathological Gleason
score 8-10, extracapsular extension, seminal vesicle invasion, and lymph node invasion, respectively. The
5-year BCR-free survival rates were 96.1% and 95.7% in active surveillance candidates and in those with
the same criteria but with biopsy Gleason score 3+4, respectively (p=0.9).
Discussion
Patients with limited involvement of Gleason score 3+4 at extended biopsy sampling who fulfill all the other
active surveillance criteria are not at increased risk of unfavorable disease and BCR after surgery. Although
these results might indicate that also selected patients with biopsy Gleason score 3+4 may be considered for
active surveillance, further studies are needed to test the oncological safety of the inclusion of these patients
in active surveillance protocols.
Conclusions
In active surveillance candidates, limited biopsy Gleason score 3+4 at extended biopsy sampling does not
substantially increase the risk of unfavorable disease at final pathology.
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Scopo del lavoro
The use of statins at the time of diagnosisi has been shown to have a protective effect on the risk of prostate
cancer mortality in a cohort of individuals recently diagnosed with prostate cancer. We retrospectively
collected data on statin use at baseline in a phase 3 randomised trial of intermittent androgen deprivation
using an LHRH analogue ( Triptoreline) and ciproterone acetate. The objective is to investigate if the results
on statin use can be confirmed.
Materiali e metodi
1045 men with a median PSA of 15,9 ng/ml were registered between October 1999 and September 2007
and 918 were randomized. Follow up for this analysis ceased in October 2012. Inclusion criteria were:
histologically confirmed prostate adenocarcinoma, cT3-T4 M0-M1, serum PSA >4 ng/ml and PSA <= 100
ng/ml, age <= 80 yrs, World Health Organization ( WHO) performance staus 0-2, and normal liver function
not suitabile for definitive treatment. Data on statin use on registration to the study was collected from 252
patients in 8 centers, of whom 129 did not use statins and 123 used statins.
Risultati
Among this subgroup of patients 115 received continuos therapy and 137 intermittent. Within the continuous
arm 49,6% of patients used statins while among the intermittent arm 48,2% used statins. Among those who
used statins 21 died ( 12 from Prostate Cancer ( PC), 5 from cardiovascular disease ( CVD) , 4 other causes)
and among those who did not use statins 45 died ( 25 from PC, 14 from CVD, 6 other causes). Metastatic
status and statins use were the only variables associated with overall survival with the hazard ratio of death
on statins ( compared to no statins) is 0,39 ( 95% CI 0.23 , 0.65), p = 0.0004. For prostate cancer death the
correspondinghazard ratio is 0.44 ( 95% CI 0.22, 0.90) , p= 0.025, and for CVD death it is 0.30 ( 95% CI
0.11, 0.83), p= 0.020.
Discussione
This investigation confirms the results reported by Geybels et al ( 2013) in that prior use of statins is
associated with better survival among men with newly diagnosed prostate cancer.
Conclusioni
New studies should be done to confirm this hypothesis
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P 176
FIDUCIAL MARKERS FOR ADAPTIVE IGRT IN LOCALIZED PROSTATE CANCER:7 YEARS
SINGLE CENTRE EXPERIENCE
HOW TO EXPAND INDICATIONS FOR ACTIVE SURVEILLANCE WITHOUT
COMPROMISING CANCER CONTROL: A SYSTEMATIC ASSESSMENT OF THE CURRENTLY
USED CRITERIA FOR PROSTATE CANCER PATIENTS
V. Lacetera, M. Cardinali, G. Mantello, F. Fenu, S. Maggi, A. Conti, G. Sbrollini, G. Muzzonigro, A. Galosi
(Ancona)
Scopo del lavoro
Describe our technique of ultrasound-guided implantation of gold markers in the prostate for adaptive IGRT
to obtain a better 3-D visibility of the prostate in a group of prostate cancer (PCA) patients and to report
the main advantages in terms of reduction of CTV (Clinical Target Volume)-PTV( Planning Target Volume)
margins and consequently in terms of side effects.
Materiali e metodi
78 PCA patients, median age 75 y were submitted to intra-prostatic implantation of gold marker for adaptive
IGRT (period 2007-2013).Inclusion criteria:low-intermediate risk PCA according to D’Amico classification.
Gold markers were inserted on ultrasound guidance by the 2 referring Urologists.We recorded complications
of the procedure. The Planning CT was acquired 7 days after implantation, when markers stability was
achieved: we report the gain of using gold markers, the maximum distance between the CTV and the re PTV
and IGRT toxicity was recorded and classified according to the LENT SOMA score.
N. Fossati, G. Gandaglia, A. Nini, U. Capitanio, L. Villa, V. Scattoni, A. Salonia, R. Bertini, V. Mirone, R.
Damiano, F. Cantiello, F. Montorsi, A. Briganti (Milano)
Aim of the study
Several inclusion criteria have been proposed to enrol prostate cancer (PCa) patients in active surveillance
(AS) protocols. However, despite their accuracy, such criteria result too stringent and challenging to be
applicable in clinical practice. As a consequence, based on currently available criteria, only few patients can
be actually recruited. We decided to systematically assess the ability of each clinical predictor in selecting
potential candidates for AS.
We included 2,077 PCa patients with complete preoperative data treated with radical prostatectomy and
pelvic lymph node dissection at a single Tertiary Care Institution between 2008 and 2013. We calculated the
number of patients who could be candidate for AS according to the criteria proposed by Van De Bergh et al.
(PSA≤10 ng/ml, PSA density
Risultati
Technique:with the patient in left lateral position three fiducial gold markers (0.9 mm x 3 mm) were placed
in the prostate (lateral mid left gland, apex and right base) under ultrasound guidance. The correct gold
markers position was verified by fluoroscopy. No cases of severe early or late complications are reported.
Haematuria, rectal bleeding, dysuria and haematospermia affected 5–15% of patients, all cases at Grade 1
or 2. Mean pain score during the procedure was 2 (range 0–10). IGRT implication and side effects: the rePTVs resulted thinner than standard ones (10 mm) for all the patients: 1 mm cranial, 1 mm caudal, 3.5 mm
anterior, 3 mm posterior, 2 mm left and 2.5 mm right. The toxicity was reported for 57/78 patients with at
least 12 months follow up. At a median follow up of 34 months (12-84) we recorded 8 G1, 5 G2 late rectal
toxicity and 8 G1, 1 G2, 2 G3 late bladder toxicity.
Results
Overall, 320/2077 (15.4%) patients met all the criteria to be enrolled. Mean and median number of cores
taken was 16 and 14 (range:12-24). However, 89/320 patients (27.8%) harboured UD at final pathology.
When PSA, PSA density or clinical stage were excluded from the criteria, only few more patients could be
enrolled [+39 pts (+12.2%), +25 (+7.8%) or +2 (+0.6%), respectively] and virtually the same prevalence of
patients harboured UD (26.5% vs. 28.1% vs. 27.6%, respectively; p=0.8). When Gleason score was excluded
from the criteria 360 more patients could be enrolled [+40 (+12.5%)], although this led to a significant
higher prevalence of UD (119/360, 33.1%; p=0.03). Similarly, when number of positive cores was excluded,
887 patients [+567, +177.2%] patients fulfilled the criteria but up to 35.7% (317/887) harboured UD.
Considering the most parsimonious model (biopsy Gleason sum 6 and percentage of positive cores
Discussione
The prostate gland can be displaced by more than 1 cm on day-to-day radiotherapy session resulting in
geographical miss of the target and unintentional irradiation of surrounding critical structures. For this
reason, a standard margin of 1 cm (CTV-PTV margin) is added to CTV to define the PTV. Image-Guided
Radiotherapy (IGRT) allows the inter-fraction prostate motion correction. Moreover, gold markers inserted
in the prostate gland can help the visualization and correction of prostate position before treatment: we
demostrate in our study the usefullness of fiducial markers implantation in the prostate before IGRT in term
of reducing Planning Target Volume and consequently in its late toxicity.
Discussion
We proposed a user-friendly 2-variables tool to extend AS to one third more of contemporary PCa patients
without compromising cancer control.
Conclusions
Gleason score sum at diagnosis and percentage of positive cores are the most informative variables that may
help in select candidates for active surveillance protocols.
Conclusioni
We report our technique of ultrasound-guided fiducial gold markers implantation with its early and late
complications in a group of PCA patients: it’s a safe and well-tollerated procedure and it results helpful to
reduce CTV-PTV margin in all cases. As expected, toxicity resulted were very low, with few cases of G1-G2
late side effects and only 2 cases of G3 bladder toxicity.
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MULTIPARAMETRIC MAGNETIC RESONANCE IMAGING (MPMRI) OF PROSTATE CANCER
LESIONS - HOW MUCH DO WE HAVE TO LEARN?
PREDICTION OF LONG-TERM CLINICAL PROGRESSION FREE SURVIVAL AFTER
RADICAL PROSTATECTOMY AND ADJUVANT RADIATION THERAPY IN PROSTATE
CANCER PATIENTS WITHOUT LYMPH NODE INVASION: RESULTS OF CONDITIONAL
SURVIVAL ANALYSES
G. Patruno, G. Gaziev, E. Serrao, L. Carmona-Echeverria, K. Wadhwa, T. Barrett, V. Gnanapragasam, A.
Doble, B. Koo, R. Miano, C. Kastner (Roma)
Aim of the study
The introduction of functional mp-MRI imaging has enabled imaging to evolve from a having a limited
role in local staging of prostate cancer to being able to detect tumours with a relatively high sensitivity and
specificity. This study is aimed at determining the accuracy of multiparametric Magnetic Resonance Imaging
(mpMRI) during the learning curve of radiologists in a tertiary-referral cancer centre using MRI targeted,
transrectal ultrasound guided transperineal fusion biopsy (MTTP) for validation.
Prospective data on 340 consecutive patients was collated. Patients underwent mpMRI read by two
radiologists in line with ESUR standards followed by MTTP biopsy of the lesion (targeted biopsy). ). Our
first 70 patients in 2012 (Group A) and the last 70 patients of 2013 (Group E) were compared. A 5-point
likert scale of probability was used to determine lesions suspicious for cancer, with scores ≥3 taken as a
positive MR-target. We compared sequential groups to determine the learning curve. Statistical analysis was
performed with chi-square correlation test.
Results
We detected a positive mpMRI in 64 patients from group A (91%) and 52 patients from the group E (74%).
Prostate cancer (CaP) detection rate on mpMRI increased from 42% (27/64) in group A and 81% (42/52)
in group E (p value 0.003). CaP detection rate by targeted biopsy increased from 27% (17/64) in group A
and 63% (33/52) in group E (p value 0.001). The negative predictive value of MRI for significant cancer (>
Gleason 3+3) was 88.9% in group E vs 66.6% in group A (see Table).
Discussion
.
Conclusions
We demonstrate an improvement in detection of CaP for MRI reporting over time, suggesting a learning
curve for the technique. Despite an improved negative predictive value for significant cancer, this did not
reach a level whereby biopsy can be avoided in MR negative cases.
P. Dell’Oglio, N. Suardi, A. Gallina, M. Bianchi, L. Villa, N. Buffi, G. Lughezzani, A. Larcher, C. Cozzarini,
N. Di Muzio, F. Montorsi, A. Briganti (Milano)
Aim of the study
Previous studies demonstrated that early biochemical recurrence (eBCR) have an higher risk of experiencing
clinical progression (CP) after radical prostatectomy (RP). The aim of this study was to examine the impact
of length of BCR on future CP probability, otherwise known as the effect of conditional survival (CS), in
patients treated with RP and aRT.
The study included 403 patients treated with RP and pelvic lymph node dissection for p2/pT3 node negative
prostate cancer with or without positive surgical margins, at our Institution between 1993 and 2008. All
patients underwent local 3D conformational radiotherapy in the prostatic bed +/- pelvic lymph-nodal yield
(92.3% vs 7.7%). Biochemical recurrence was defined as a post-operative PSA > 0.2 ng/ml and raising.
Clinical progress was defined as any clinical and/or radiological evidence of disease recurrence. KaplanMeier methodology was employed to assess the BCR-free survival rates, and the CR-free survival rates after
BCR. Cumulative survival estimates were used to generate conditional CR-free survival rates assessed at a
5-year interval. The same analyses were subsequently repeated after stratification according to Gleason score
(GS
Results
Overall, 108 (26.8%) patients experienced BCR after RRP and aRT. The mean follow-up time after aRT
was 96 months (median 93 months). Within patients who experienced BCR, 40 (37%), 32 (29.6%), 36
(33.4%) patients recurred within 2, between 2 and 4, and after 4 years after aRT, respectively. Overall, the 5
year clinical relapse free survival rates after BCR was 56.7%. Among patients who developed BCR within
the first 2 years, between the 2nd and 4th year and after 4 years following aRT, the probability to be CRfree survival in the following five years was 44.8, 59, 64.7%, respectively. After stratification according to
Gleason score, the overall 5 years CR-free survival rates after BCR was 57.6 and 45.3% in patients with
Gleason score 6-7 and 8-10, respectively (p=0.03). Moreover, the 5-year CR-free survival rates for patients
who experienced BCR within the first 2 years and after 2 years was 41.8 vs. 28.6% and 63.5 vs. 55.6% in
patients with Gleason 6-7 vs. 8-10, respectively (p=0.03). Finally, at multivariable Cox regression analysis
predicting CR after BCR, time to BCR emerged as the most significant predictor of CR (HR 0.98; 95% CI:
0.97-0.99; p <0.001).
Discussion
The postoperative BCR-free survivorship period may have an important impact on the subsequent CR risk.
Specifically, patients who experience early BCR are at higher risk of developing CR.
Conclusions
This effect appears to be more relevant in patients with aggressive disease characteristics. These results
should be validated in larger patient cohorts.
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PREDICTORS FOR RESPONSE TO INTERMITTENT ANDROGEN DEPRIVATION (IAD) IN
PROSTATE CANCER CASES WITH BIOCHEMICAL PROGRESSION AFTER SURGERY
PREDICTORS OF EARLY FAILURE AFTER TIMELY ADMINISTERED SALVAGE
RADIOTHERAPY FOR BIOCHEMICAL RECURRENCE AFTER RADICAL PROSTATECTOMY
S. Salciccia, A. Sciarra, A. Gentilucci, M. Innocenti, F. Minisola, F. Di Quilio, V. GENTILE (Roma)
N. Suardi, G. Gandaglia, N. Di Muzio, C. Cozzarini, S. Joniau, M. Sun, B. Tombal, K. Haustermans, W.
Hinkelbein, S. Shariat, P. Karakiewicz, H. Van Poppel, T. Wiegel, F. Montorsi, A. Briganti (Milano)
Scopo del lavoro
To define characteristics of the first cycle of intermittent androgen deprivation (IAD) that would predict for
outcomes in a long term follow-up.
Materiali e metodi
We started a prospective study of IAD for the treatment of biochemical progression (BP) after radical
prostatectomy (RP) for prostate cancer (PC). The end-points of the trial were time to clinical progression
(CP) and time to castration resistance PC (CRPC). Eighty-four cases were included in the study. In all cases,
after an initial induction period, an acceptable nadir to switch from on-to-off-phase of IAD was considered
to be a serum PSA 1.0 ng/ml. Measurements: As possible predictors for time to CP and CRPC, we analyzed
pretreatment parameters such as age, Gleason Score, serum PSA, testosterone, chromogranina A (CgA)
levels, and characteristics from the first cycle of IAD.
Risultati
Mean follow-up during IAD was 88.6+/- 16.7 months; 29.7% of patients developed CRPC and 14.2%
of cases showed a CP with a mean time of 88.4+/- 14.3 months and 106.5+/- 20.6 months, respectively.
At univariate and multivariate analysis, the PSA nadir during the first on-phase period and the first offphase interval resulted in significant and independent predictors (P 0.001) of the time to CRPC and CP. In
particular for cases with a PSA nadir 0.4 ng/ml and for those with an off-phase interval 24 weeks,the risk of
CRPC and CP during IAD was 2.7–2.5 and 3.0 –3.1 times that for patients with a PSA nadir 0.1 ng/ml and
with an off-phase interval 48 weeks, respectively.
Discussione
To obtain a better balance between tumor control and side effects related to the therapy, IAD could be
preferred to a continuous therapy.The purpose of our present analysis was to explore characteristics of the
first cycle of IAD and to compare these with baseline clinical characteristics that could predict outcomes in
terms of CRPC or CP development.
Conclusioni
Cases with BP after RP selected to IAD that show at the first cycle a PSA nadir 0.1 ng/ml and a off-phase
interval 48 weeks may identify candidates who will experience better response to IAD treatments and
delayed CP or CRPC development.
Aim of the study
Although previous studies evaluated the efficacy of early salvage radiotherapy (eSRT) in prostate cancer
(PCa) patients experiencing biochemical recurrence (BCR) after radical prostatectomy (RP), none of them
identified the predictors of early treatment failure in these patients. The aim of our study was to assess
predictive factors associated with early failure of eSRT given for BCR after RP.
Using a multi-institutional cohort, 472 patients who received eSRT for BCR after RP between 1993 and
2009 were identified. All patients had histologically confirmed pT2/pT3, R0–R1, pN0 disease at RP and
undetectable PSA values (0.2 ng/ml) within 2 months after eSRT. Univariable and multivariable regression
analyses were performed to test the association between patient characteristics at RT(surgical margin status,
pathological GS, tumor stage, radiotherapy dose, time from surgery to eSRT, and PSA at RT) and treatment
failure after eSRT.
Results
Mean patient age was 62.3 years (median: 63). Pathological stage distribution at RP was pT2, pT3a and
pT3b in 46%,36% and 18% of patients, respectively. Positive surgical margins were present 49.8% of all
patients. Gleason score distribution was ≤6,7 and 8-10 in 44.5%, 39% and 16.5% of patients, respectively.
Median PSA at sRT was 0.24 ng/ml (IQR:0.13-0.35 ng/ml). Median dose of sRT was 67.9 (IQR: 66.6-70.2).
Overall, 25 (5.3%) patients experienced early treatment failure after eSRT. At univariate logistic regression
analyses, surgical margins, pathological Gleason score, and radiotherapy dose were associated with higher
risk of detectable PSA levels after treatment. Particularly, patients with positive surgical margins had 3.4fold higher risk of having detectable PSA after eSRT compared to those with negative margins (P=0.01).
Similarly, men with pathological Gleason score 8-10 had 3.7-fold higher probability of experiencing
treatment failure compared to their counterparts with GS 2-7 (P=0.01). Finally, lower radiotherapy dose
was associated with higher risk of treatment failure (P=0.005). These observations were confirmed at
multivariate analysis, where surgical margin status, pathological Gleason score 8-10, and radiotherapy dose
represented independent predictors of treatment failure, after adjusting for confounders (all P≤0.04).
Discussion
Positive surgical margins at RP, pathological Gleason score 8-10, and lower dose of radiotherapy represent
independent predictors of treatment failure after eSRT.
Conclusions
These parameters should be used to identify patients who might benefit from concomitant systemic
treatment administration at time of eSRT and/or whole-pelvis radiotherapy in the context of a multimodal
salvage approach.
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SELECTING THE OPTIMAL CANDIDATE FOR ADJUVANT RADIOTHERAPY AFTER
RADICAL PROSTATECTOMY AMONG PATIENTS WITH LYMPH NODE METASTASES FROM
PROSTATE CANCER
SIURO-PRIAS-ITA PROJECT: FOUR YEAR EXPERIENCE ON ACTIVE SURVEILLANCE
D. Vizziello, F. Abdollah, N. Suardi, A. Gallina , C. Cozzarini, M. Picchio, M. Bianchi, P. Dell’Oglio, A.
Nini, D. Di Trapani, A. Salonia, F. Montorsi, A. Briganti (Milano)
Aim of the study
The role of adjuvant radiotherapy (aRT) in prostate cancer (PCa) patients with lymph node metastases (LNI)
is controversial. We tested the hypothesis that the impact of aRT on cancer-specific mortality (CSM) in these
individuals is related to different tumor characteristics.
We evaluated data of 1,107 pN1 PCa patients treated with radical prostatectomy and anatomically extended
pelvic lymph node dissection between 1988 and 2010 at two tertiary care centers. All patients received
adjuvant hormonal therapy with or without aRT. Regression tree analysis stratified patients into risk-groups
based on their tumor characteristics and the corresponding CSM rate. Univariable and multivariable cox
regression analysis tested the relationship between aRT and CSM rate in each risk-group separately.
Results
Overall, 35% of patients received aRT. Using the regression tree analysis, the cohort was stratified into five
risk-groups: very low-risk (number of PLNs ≤2, and Gleason score 2-6), low-risk (number of PLNs ≤2,
Gleason score 7-10, pT2/pT3a stage and negative surgical margins), intermediate-risk (number of PLNs ≤2,
Gleason score 7-10, and pT3b/pT4 stage or positive surgical margins), high-risk (number of PLNs =3-4),
and very high-risk group (number of PLNs >4). The discrimination accuracy of this model to predict 8-year
CSM was 72%. At multivariable analysis aRT was associated with more favorable CSM rate (hazard ratio
[HR]: 0.37, p
Discussion
The beneficial impact of aRT on survival in pN1 PCa patients is highly influenced by tumor characteristics.
Conclusions
Men with low-volume LNI (≤ 2 positive lymph nodes) in presence of intermediate to high-grade, nonspecimen confined disease and those with intermediate-volume LNI (3-4 positive lymph nodes) represent
the ideal candidates for aRT after surgery.
C. Marenghi, G. Conti, M. Gallucci, R. Papalia, G. Martorana, D. Diazzi, M. Tanello, E. Frego, R.
Sanseverino, G. Napodano, P. Graziotti, G. Taverna, A. Turci, G. Cicchetti, P. Ditonno, M. Colecchia, C.
Bangma, R. Valdagni (Milano)
Aim of the study
We here report on the 4 year SIUrO-PRIAS-ITA experience on Active Surveillance (AS). Special focus is on
the correlations between Active Treatment Free Survival (ATFS) and patient’s characteristics at diagnosis,
with the aim of investigating the ability to predict disease reclassification.
In December 2009 the SIUrO-PRIAS-ITA project started including patients in PRIAS (Prostate cancer
Research International: Active Surveillance). Eligibility criteria are: iPSA≤10ng/ml, Gleason Score≤6, T1c
or T2a, PSA density≤0.2ng/ml/cc, maximum 2 positive cores. Actuarial ATFS was assessed using KaplanMeier analysis. Correlation between ATFS and clinical risk factors was determined using the log rank test
and Cox Proportional Hazards Model.
Results
Between Decembe 2009 and January 2014, 480 patients were enrolled in SIUrO-PRIAS-ITA. Median age
at inclusion was 65 years (range 42-80 years), median iPSA was 5.46 ng/ml (range 0.5-9.91ng/ml). 355/480
patients (74%) are still on AS with a median follow-up of 21 months (range 2-59 months), median time
in AS is 14 months (range 0.13-58.8mos). 137/480 (28.5%) patients had two positive cores at diagnostic
biopsy. 457/480 (92.5%) patients were classified as T1c at DRE. 80 patients (16.6%) dropped out from AS
because of disease progression/reclassification: 6 due to PSA doubling time and 72 due to upgrading and/or
upsizing at re-biopsy (54/72 at 1 year re-biopsy). 36 patients dropped out due to off-protocol reasons (mainly
comorbidities or personal choice).
Discussion
Biopsy-driven ATFS resulted to be correlated to PSA density≤0.12ng/ml/cc (p=0.022, ATFS at 30 months
83% vs 78%, ATFS at 48 months 77% vs 43%), prostate volume (p=0.01, volume stratified in three groups:
≤40 cc, 40-60 cc, ≥ 60cc, ATFS at 30 months 73% vs 78% vs 88% respectively, ATFS at 48 months 63%
vs 74% vs 85%), DRE=T2a (p=0.009, ATFS at 30 months 80% vs 56%, ATFS at 48 months 76% vs
42%), number of positive cores at diagnostic biopsy=2 (p=0.006, ATFS at 30 months 84% vs 67%, ATFS
at 48 months 79% vs 60%). and number of total cores at diagnostic biopsy≤12 (p=0.019, ATFS at 30
mosnths73% vs 84%, ATFS at 48 months 69% vs 77%). Kaplan Meier curves are shown in figures 1. Best fit
multivariable Cox model for biopsy-driven ATFS resulted in a 3-variable model (overall p=0.03, AUC=0.70)
including DRE= T2a (risk factor, p=0.04, HR=2.2), prostate vol≤60cc (risk factor, p=0.18, HR=1.86) and
PSA density (continuous variable, risk factor, p=0.33, HR=1.03).
Conclusions
AS is feasible in selected men with early prostate cancer. Most of drop out occurred due to 1 year re-biopsy
which should probably be considered as a confirmatory biopsy. PSA density, DRE, number of positive
cores at diagnostic biopsy and prostate volume correlate with biopsy-related ATFS as risk factors for
reclassification. Cox multivariable model confirms the independent value of PSA density, DRE and prostate
volume.
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189
P 183
P 184
VOIDING SYMPTOMS, INCLUDING BLADDER PAIN, RELATED TO POST RADIATION
TREATMENT FOR PCA ARE IMPROVED BY IALURIL®: A PROSPECTIVE OBSERVATIONAL
STUDY
WATCHFULL WAITING (WW) FOR INCIDENTAL CARCINOMA OF THE PROSTATE (CAP) :
LONG TERM RESULTS
C. Giannessi, M. Gacci, O. Saleh, D. Villari, T. Chini, P. Della Camera, A. Raugei, V. Li Marzi, B. Detti, E.
Finazzi Agro’, A. Minervini, M. Carini, S. Serni (Firenze)
Aim of the study
Hyaluronic acid chondroitin sulfate represents the replacement of the protective lining in bladder known
as Glycosaminoglycan, or GAG layer. The aim of our prospective observational study is to evaluate the
efficacy of hyaluronic acid chondroitin sulfate (Ialuril®) administration in men with bladder pain syndrome
(BPS) after radiotherapy (RT) for prostate cancer.
Twenty-three consecutive patients (mean age: 67.9) with bladder pain syndrome due to pelvic irradiation
for locally advanced prostate cancer (16 treated with radical prostatectomy [RP] plus RT and 7 with RT
alone) were enrolled from May 2012 to October 2013. Patients underwent intravesical administration of
Ialuril® weekly for the first month, and on the 6th, 8th and 12th week subsequently. The Interstitial Cystitis
Symptoms Index (ICSI), the Interstitial Cystitis Problem Index (ICPI) and Pelvic Pain and Urgency/
Frequency questionnaire (PUF) were self-administered immediately after RT and at the end of treatment
with Ialuril (12th week) to evaluate the relapse of symptoms. Data were analyzed with Paired samples T test,
and subsequently adjusted for age, primary treatment (RP+RT vs. RT alone), radiotherapy dose and toxicity.
Results
Median (range) pre and post-treatment ICSI score was 7.91 (1-17) and 5.43 (0-14) respectively (p=0.002). In
particular, the most significant items were urgency, frequency and nocturia (p=0.033, p=0.031 and p=0.001
respectively). At multivariate analysis, only the grade of toxicity resulted determinant for the response to
Ialuril (r: 0.735,p=0.037). Median (range) pre and post-treatment ICPI score was 7.22 (1-13) and 6.04 (010) respectively (p=0.068).In particular, the most significant items were nocturia and pain (p=0.016 and
p=0.010 respectively).No significant data were obtained at multivariate analysis. Median (range) pre and
post-treatment PUF score was 6.57 (3-13) and 5.13 (1-10) respectively (p=0.015). In particular, the most
significant items were pollachiuria, pain and urgency (p=0.001, p=0.031 and p=0.024 respectively).
M. Brausi, G. De Luca, M. Viola, G. Peracchia, M. Gavioli, G. Verrini, G. Simonini, A. Romano (carpi)
Scopo del lavoro
The treatment of incidental carcinoma of the prostate is still controversial. The aim of this retrospective
study was to evaluate the long term survival in patients with incidental CAP diagnosed after TURP or open
prostatectomy and followed with observation only
Materiali e metodi
The records of 93 pts with incidental CAP diagnosed from 1976 to 1984 were reviewed. Mean pts. age
was 68.2 years. All pts included presented at our clinic because of lower urinary tract symptoms. 56/93
pts. (60.2%) were diagnosed to have CAP after open prostatectomy while 37/93 (38.8%) after TURP. The
specimens were reviewed by a senior pathologist and re-staged according to TNM. 52 pts had T1a while
41 had T1b CAP. According to Mostofi grading system, 48 pts had G1 tumours, 34 had G2, 5 G3 and 6 Gx
. After surgery pts did not receive any additional treatment and were followed according to WW protocol.
Minimum follow-up was 10 years. 75 patients had 15 and 10 pts had 20 years follow up respectively.
Risultati
10 and 15 years overall survival (OS) was 76% and 50.1% while the disease specific survival (DSS) was
86% for T1a and 85.7% for T1b. The 10 years DSS for G1-G2 tumours was 86% compared to 37.5% for G3.
14/93 (15%) pts progressed: 4 pts had local and 10 systemic progression. Mean time to progression was 7.5
years. 12 pts died because of the disease and 2 are still alive with metastases. All G3 tumours progressed. In
G2 and G1s progression occurred in 5/34 (14.7%) and 4/48 (8.3%) respectively.
Discussione
WW strategy can be proposed to patients with incidental CAP.
Conclusioni
It should be considered a great opportunity expecially for low and intermediate grade (G1-G2) tumors .
Incidental, High grade CAP should be treated more aggressively.
Discussion
Key elements of GAGs layer are hyaluronic acid (HA) and chondroitin sulphate (CS). When this layer
is damaged a neuroinflammatory cascade is activated causing voiding symptoms and bladder pain. The
treatment model to be proposed must therefore aims to reduce mast cell mediated neuro-inflammatory
cascades and to replace the GAGs layer. IALURIL® (Hyaluronic Acid Chondroitin Sulfate) have been
demonstrated to be effective in reducing mast cell degranulation and replacing GAGs layer.
Conclusions
Ialuril demonstrated to be a promising medical device regardless to treat post radiation bladder. Men with
higher toxicity presented a most remarkable reduction of ICSI as compared to those with lower toxicity. This
data should be confirmed by randomized controlled trials.
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P 185
P 186
A PROPOSED NEW RISK CLASSIFICATION FOR INTERMEDIATE RISK PATIENTS WITH
PROSTATE CANCER (PCA) TREATED WITH RADICAL PROSTATECTOMY (RP)
GLYCATED HEMOGLOBIN (HBA1C) LEVELS ARE INDEPENDENTLY ASSOCIATED WITH
UNFAVOURABLE PROSTATE CANCER AND DISEASE RECURRENCE AFTER RADICAL
PROSTATECTOMY
M. Brausi, N. Papa , D. Muller, A. TA, N. Lawrentschuk, G. Severi , J. Millar , R. Syme , G. Giles , D.
Bolton (Carpi)
Aim of the study
The treatment of intermediate risk patients is still controversial due to the heterogeneity of the patients
falling in this category. The aim of this study was to evaluate the long-term outcome of PCa patients with
intermediate risk according to the D’Amico classification who received RP in Victoria, Australia and to subclassify them eventually according to their pre-operative PSA (≤/> 10ng/ml), Gleason score (≤6, 3+4, 4+3)
and stage (T1c, T2a, T2b).
Between 1995 and 2000, 2154 men with PCa underwent open RP and were recorded in the Victorian
Cancer Registry. Complete clinic-pathologic data were available for 1894 men. According to the D’Amico
classification 916 patients were at intermediate risk. Median age for this group was 62.6 years, median preop PSA was 10.1 ng/ml, Gleason Score (GS) ≤6 in 58%, GS 3+4 = 31.4%, GS 4+3 = 10.6%. cStage: T1c =
38.1%, T2a = 19.4%, T2b = 42.5%. 57.6% of pts. received lymph node dissection. We divided these patients
into 4 groups: Group A (n=200): Psa ≤10ng/ml, GS ≤6, cT2b. Group B (n=194): Psa ≤10ng/ml, GS 3+4.
Group C (n=331): Psa 10-20ng/ml, GS ≤6. Group D (n=191): Psa 10-20ng/ml, GS 3+4 and any GS 4+3).
Biochemical recurrence (BR), overall and prostate cancer specific survival hazard ratios were calculated for
all the groups.
Results
Median follow-up was 10.3 years. The overall number of deaths for the intermediate risk patients was 120
(13.1%). 23 (11.5%) in Group A, 15 (7.7%) in Group B, 47 (14.2%) in Group C and 35 (18.3%) in Group
D. Biochemical recurrence: Group A = 25%, Group B = 32.5%, Group C = 36%, Group D = 14 (7.3%). PCa
death: Group A = 8 (4%), Group B = 2 (1%), Group C = 6 (1.8%), Group D = 14 (7.3%). When comparing
D’Amico low risk patients with Group A, no significant difference in biochemical recurrence rates was
found vs. a significant difference for groups B, C and D. When the D’Amico high-risk group was compared
to Group D, no significant difference in BR or PCa mortality was observed vs. significant differences
for groups A, B and C. BR and mortality rates were also calculated for patients grouped according to the
presence of 1, 2 or 3 negative intermediate risk factors (Psa 10-20 ng/ml, GS 7, cT2b). When three factors
were present, BR and PCa mortality rates were comparable to the D’Amico high-risk group. When only one
factor was present, PCa mortality was similar to the low risk patients.
Discussion
The intermediate risk group should be sub-categorized into intermediate-low and intermediate-high risk.
Intermediate-low risk are patients with Psa ≤ 10ng/ml Gleason score ≤ 6, cT2b i.e. patients with only stage
as their intermediate risk factor. Active Surveillance should be the treatment of choice .
A. Gallina, M. Moschini, M. Bianchi, M. Tutolo, F. Castiglione, N. Fossati, A. Nini, F. Cantiello, R.
Damiano, V. Mirone, R. Bertini, F. Montorsi, A. Briganti (Milano)
Aim of the study
Previous studies have shown that diabetic patients diagnosed with prostate cancer (PCa) and treated with
radical prostatectomy (RP) may be at higher risk of harbouring unfavourable PCa at final pathology. We
hypothesized the glycated haemoglobin (HbA1c) levels, regardless of a previous diagnosis of diabetes, may
be associated with adverse PCa features and higher risk of recurrence after RP
The study included 1,249 patients treated with RP for clinically localized PCa between 2008 and 2011 at a
single tertiary care center. Pre-operative HbA1c was measured in all patients the day before surgery. Uniand multivariable logistic regression models tested the association between HbA1c and pathological stage,
defined as extracapsular extension (ECE), seminal vesicle invasion (SVI) and lymph node involvement
(LNI). Univariable and multivariable Cox regression analyses evaluated the role of HbA1c in predicting
biochemical recurrence (BCR), defined as PSA ≥0.2 ng/ml and rising. Covariates consisted of total PSA
at diagnosis, biopsy Gleason sum and clinical stage. HbA1c was tested as both continuous and categorical
variable, according to the WHO classification (namely 6.5%)
Results
Mean and median pre-operative HbA1c levels were 5.73 and 5.60%, respectively (range 4.0-10.8%).
Overall, HbA1c was 6.5% in 643 (51.5%), 500 (40%) and 106 (8.5%) patients, respectively. According
to patient medical history, 124 (9.9%) had a diagnosis of diabetes. Mean and median PSA were 12.3 and
6.8 ng/mL, respectively. Clinical stage was T1 in 54.7%, T2 in 30.4% and T3 in 14.9% of the patients.
Biopsy Gleason sum was 6 in 58.2%, 7 in 30.1% and 8-10 in 11.7% of the patients. Median follow up was
34 months (range 1-118). At multivariable logistic regression analyses, after adjusting for PSA, clinical
stage and biopsy Gleason sum, HbA1c was an independent predictor of SVI (OR 1.43; p=0.003) and LNI
(OR 1.38, p=0.01). At multivariable Cox regression analyses, HbA1c categorized according to the WHO
definition was independently associated with the risk of BCR (p=0.02), after accounting for confounders.
Patients with HbA1c >6.5% had a 2.01 higher risk of BCR as compared to those with HbA1c
Discussion
Increased levels of HbA1c are independently positively associated with more adverse pathological features
and higher BCR rates.
Conclusions
These results should be taken into account when diabetic patients are considered for curative treatments of
PCa.
Conclusions
Any patient with GS 4+3 or GS 3+4 with PSA 10-20ng/ml should be classified as intermediate-high risk.
These patients have a high probability of BR and PCa mortality and should receive active treatment.
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P 187
P 188
IMPACT OF PROSTATE VOLUME ON THE RISK OF BIOCHEMICAL RECURRENCE AFTER
RADICAL PROSTATECTOMY
Can the preoperative prostatic multiparametric-MRI improve the results
of laparoscopic/ robotic-assisted radical prostatectomy?
A. Nini, N. Fossati, G. Gandaglia, A. Gallina, M. Bianchi, M. Moschini, V. Cucchiara, E. Zaffuto, V.
Mirone, R. Colombo, A. Salonia, F. Montorsi, A. Briganti (Milano)
C. Fiori1, Regge D.3, F. Mele1, M. Manfredi1, R. Bertolo1, Garrou D.1, Amparore D.1, G. Cattaneo1, F.
Russo3, I. Morra1, Bollito E.2, M. Papotti2, F.Porpiglia1 .
Department of Urology1; Department of Pathology2 - University of Turin, San Luigi Hospital, Orbassano
(Turin); Radiology Unit3, IRCC, Candiolo (Turin).
Aim of the study
Evidence is conflicting regarding the role of prostate volume (PV) on the risk of biochemical recurrence
(BCR) in patients with prostate cancer (PCa) treated with radical prostatectomy (RP). While retrospective
studies relying on historical cohorts indicated a possible impact of PV on BCR-free survival rates,
others failed to confirm these observations. We aimed at evaluating the role of PV in our large cohort of
contemporary patients treated with RP at a referral institution.
Overall, 5,637 patients with PCa treated with RP between January 1993 and August 2013 were identified.
All patients had available preoperative and pathological data. Multivariable Cox regression analyses tested
the association between prostate volume (PV, continuously coded) and the risk of experiencing BCR after
surgery in the overall population, and after stratifying patients according to the D’Amico risk groups (lowvs. intermediate- vs. high-risk). Covariates consisted of surgical margin status, pathological Gleason score,
pathological stage, lymph node invasion, and the administration of adjuvant therapies.
Results
Mean patient age was 64.8 years (median: 65). Mean PV was 50.6 ml (median: 46). Overall, 1,789 (31.7%),
2,657 (47.1%), and 1,191 (21.1%) patients had low-, intermediate-, and high-risk PCa, respectively. Mean
(median) PV was 51.7 (48), 49.8 (45), and 50.6 (46) in patients with low-, intermediate-, and high-risk PCa,
respectively (P=0.04). Overall, the 5-year BCR-free survival rate was 87.9%. In the entire population, PV
was associated with lower risk of BCR (Hazard ratio [HR]: 0.99, 95% Confidence Interval [CI]: 0.99-1.00;
P=0.03), after accounting for confounders. However, when patients were stratified according to D’Amico
risk groups, PV represented an independent predictor of BCR only in patients with intermediate-risk
disease (HR: 0.62, 95% CI: 0.99-1.00; P=0.04). Conversely, PV was not associated with reduced risk of
experiencing BCR in patients with low- and high-risk disease (all P≥0.4). At cubic spline analyses, the risk
of BCR in patients with intermediate risk disease showed a significant decrease with prostate volume >50
cc.
Discussion
Smaller PV is significantly associated with increased risk of BCR after surgery only in men with
intermediate-risk PCa. In this patient category, PV might be used to identify patients at higher risk of BCR
after surgery, in order to individualize follow-up schedules and administer adjuvant or salvage treatments in
a timely fashion.
Conclusions
Prostate volume is significantly associated with increased risk of BCR after surgery only in men with
intermediate-risk PCa.
194
Introduction:
The prostatic multiparametric MRI (mpMRI), has gained considerable importance in the local staging of
prostate cancer (PCa). On the basis of information obtained from mpMRI, the surgeon can choose the type
of radical prostatectomy (RP) more suitable for the patient (nerve sparing unilateral, bilateral, total, partial
etc. Vs. extrafascial), performing a real surgical “tailoring”. The aim of this study is to verify if informations
obtained from mpMRI (and the consequent surgery tailoring) were able to modify the functional and oncological results after RP if compared with the indications provided by traditional clinic-pathological parameters (PSA, DRE , GS, number and location of positive samples).
We considered the data of patients undergoing to pure laparoscopic or robot-assisted RP from 01/2011 to
03/2014. The patients have been divided into two groups, depending on whether they performed a pre-operative mpMRI (group A=298 patients, group B=190 patients). Patients in group B were not subjected to
mpMRI only for organizational reasons or due to contraindications related to the procedure (claustrophobia,
presence of pacemakers or metal implants). The mpMRI endorectal coil at 1.5 T consisted of T2-weighted
sequences, with diffusion and dynamic contrast enhancement. The 2 groups were compared on the basis of
preoperative (age, PSA at diagnosis, clinical stage, BMI, Charlson Index, ASA score, biopsy GS), intra-operative (type of nerve-sparing approach) and pathological characteristics (prostate volume , GS and pathological stage). The primary endpoint of the study was to evaluate the rate of positive surgical margins, urinary
continence at catheter removal and at 1 month after RP but also sexual power at one month from the RP.
Results
The 2 groups were comparable in terms of preoperative charateristics and intraoperative and pathological
results. The rate of surgical margins was 19.8% for group A and 22.6% for group B (p = 0.053); this difference was maintained stratifying the two groups in terms of pT. Urinary continence at catheter removal was
69% in group A and 62.3% in group B (p = 0.053), while, one month later, was 81.5% and 74.2% (p = 0:27)
respectively. The sexual potency at one month (measured only in the nerve-sparing procedures) was 31.4%
in group A and 28.6% in group B (p = 0.89).
Discussion
Early oncological and functional results after RP show a favorable trend in the group of patients who underwent preoperative MRI-mp. The limited sample size did not allow to achieve statistical significance.
Conclusions
In our series, the preoperative mpMRI and the surgical tailoring based on such a imaging exam results,
seems to come out in a reduction of positive surgical margins and in a higher recovery of urinary continence
and sexual potency.
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P 189
P 190
NOMOGRAM FOR PREDICTING THE GLEASON SUM UPGRADING IN CLINICALLY
DIAGNOSED LOCALIZED PROSTATE CANCER
OUTCOME OF RADICAL PROSTATECTOMY FOR MISCLASSIFIED ACTIVE
SURVEILLANCE CANDIDATES
L. Benecchi, F. Russo, F. Echeverria, M. Potenzoni, C. Grassani, D. Martens, F. Evaristi, C. Destro
Pastizzaro, A. Prati, L. Viviano, C. Del Boca (Cremona)
N. Fossati, N. Suardi, U. Capitanio, V. Scattoni, E. Di Trapani, G. Gandaglia, P. Dell’Oglio, A. Nini, V.
Cucchiara, D. Vizziello, E. Zaffuto, F. Montorsi, A. Briganti (Milano)
Aim of the study
Although the Gleason score is commonly used in nomograms as the most powerful prognostic indicator and
is thus useful in treatment decisions, its possible upgrade after radical prostatectomy (RP) is rarely taken
into consideration. In patients with low-grade prostate cancer on biopsy, inaccurate cancer grading can
lead to a false sense of comfort for both physician and patient, and lead to under-treatment of intermediate
and high-risk cases. In these patients with biopsy Gleason 6 prostate cancer, radical local therapy may be
recommended because the clinician cannot guarantee that more aggressive cancer does not exist. Patients
undergoing radical prostatectomy have the advantage of comprehensive assessment of the Gleason score
by examination of the whole radical prostatectomy specimen. The objective of this study was to build a
nomogram for prediction of Gleason Sum Upgrading in clinically diagnosed prostate cancer.
Aim of the study
The aim of our investigation was to test the effect of unfavorable pathological characteristics on the risk of
recurrence after RP in patients who could have been selected for active surveillance.
Patients undergoing radical prostatectomy with matched diagnostic biopsies were identified from our
database. The prostate Volume, the percent free prostate-specific antigen, the number of positive cores,
the biopsy Gleason score and the clinical T stage were used in a multivariate logistic regression model for
addressing the probability of Gleason Sum Upgrading. The accuracy of the nomogram was quantified with
the Harrel′s concordance index and the calibration plot method. Two hundred bootstrap resamples were used
for internal validation.
Results
In all, 635 patients entered the study. Of them, 197 (31%) were upgraded to higher Gleason sum on final
pathology. A nomogram for a positive biopsy was developed from the final logistic regression model
findings. For internal validation and to decrease overfit bias models were subjected to 200 bootstrap
resamples. By using 5 readily available variables (prostate volume, free prostate-specific antigen, number
of positive cores, biopsy Gleason score and clinical T stage), our nomogram showed a bootstrap corrected
concordance index of 0.64.
Discussion
Because the differences between different Gleason patterns are a continuum, there are borderline grades
between small glands of pattern 3 and poorly formed glands of pattern 4. Similarly, there are borderline
grades between poorly formed glands of pattern 4 and pattern 5 with barely appreciable glandular
differentiation.
Conclusions
In summary, we have confirmed that sampling error at transrectal ultrasound biopsy is a significant cause
of Gleason score under-grading at the time of initial diagnosis. A new nomogram to predict Gleason
Sum Upgrading in clinically diagnosed prostate cancer was developed and demonstrated good statistical
performance in internal validation.
196
The study included 330 patients treated with RP between 1994 and 2013 who could have been selected
for active surveillance according to the PRIAS criteria. The rates of unfavorable disease at final pathology
(defined as non organ confined disease and/or Gleason score upgrading) were examined. Additionally,
patients were categorized in three groups according to the final pathology results: men with organ confined
disease and pathological Gleason score ≤6 (Group 1), men with organ confined disease and pathological
Gleason score 3+4 (Group 2), and patients with non-organ confined disease or pathological Gleason score
≥4+3 or pN1 (Group 3). Biochemical recurrence was defined as the detection of PSA ≥0.2ng/ml after
surgery. The Kaplan-Meier curves were used to assess the time to BCR after surgery. The long-rank test was
used to compare the rates of BCR according to pathological features.
Results
Mean patient age was 64.4 years (median: 65). Overall, 306 (92.7%), 19 (5.8%), 5 (1.5%), and 3 (0.9%)
of the patients included in the study had organ-confined disease, extracapsular extension, seminal vesicle
invasion, and lymph node invasion, respectively. Pathological Gleason score was ≤6, 3+4, and ≥4+3 in 247
(74.8%), 62 (18.7%), and 21 (6.4%) patients, respectively. When patients were stratified according to PCa
characteristics at final pathology, 243 (73.6%), 62 (18.8%), and 25 (7.6%) were included in Group 1, Group
2, and Group 3, respectively. Overall, 12 (3.6%) patients experienced BCR during follow-up. The BCR-free
survival rate at 60-month follow-up was 95.6%. When patients were stratified according to the pathological
features, individuals with worse characteristics (Group 3) had lower BCR-free survival rates compared to
their counterparts with favourable disease (Group 1) at final pathology (P
Discussion
Roughly a quarter of men of potential active surveillance candidates harbors unfavorable disease at final
pathology. While non organ confined and or Gleason score≥4+3 patients had worse cancer control after RP,
the upgrade from biopsy Gleason score ≤6 to pathological Gleason score 3+4 does not significantly increase
the risk of BCR.
Conclusions
Active therapy may be thus consider an overtreatment also in these men despite higher Gleason score (3+4).
This may suggest the potential inclusion also of these men in prospective, AS protocols.
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P 191
P 192
PERIOPERATIVE AND ONCOLOGICAL OUTCOMES IN HIGH RISK ELDERLY PATIENTS
PROPOSAL OF NOVEL RISK GROUPS FOR OUTCOME PREDICTION FOLLOWING
RADICAL PROSTATECTOMY IN CONTEMPORARY PROSTATE CANCER PATIENTS
E. De Lorenzis, B. Rocco, S. Pigilam, K. Palmer, S. Samavedi, H. Abdul Muhsin, V. Patel (Milano)
Aim of the study
ontroversy continues to exist concerning the treatment of choice for D’Amico high risk elderly patients.
The purpose of this study is to compare the perioperative and oncologic outcomes of robotic assisted radical
prostatectomy (RARP) in D’Amico high risk, propensity score-matched elderly and younger cohorts.
From January 2008 through August 2012, 3818 patients underwent RARP at our institution by a single
surgeon (VP). Retrospective analysis of prospectively collected data from our Institutional Review Board
approved registry identified 80 D’Amico high risk patients, 70 years of age and over. A propensity scorematch analysis was conducted using multivariable analysis to compare elderly patients (age 70 and over) to
those under 70. The final two study cohorts – D’Amico high risk elderly patients (n=80) and D’Amico high
risk younger patients (n=80) constituted the clinical material for this comparative study of perioperative and
oncologic outcomes.
Results
Preoperative clinical characteristics were similar for the two matched groups. The operative time,
transfusion rate and intra-operative complications were similar for the two groups.The mean estimated blood
loss was significantly greater in younger patients (156.1 ± 84.2 mL vs 113.6 ± 67.7; p=0.002). No significant
differences were observed in laterality, ease of nerve sparing or surgeon subjectively assessed anastomosis
and pathological outcomes between the groups. No significant differences were found in postoperative
complication rates, overall pain scores, length of stay or duration of indwelling catheterization. At follow-up,
freedom from biochemical recurrence (BCR) in elderly patients was 85.0% vs. 83.8% in younger patients.
The mean time to BCR in elderly patients was 15.0 months (range, 2.3 to 38.8) and 14.5 months (range, 5.2
to 35.1) in younger patients.
Discussion
Conclusions
This study clearly demonstrates that RARP can be performed in D’Amico high risk elderly patients without
increasing perioperative morbidity and with oncologic outcomes comparable to high risk younger patients.
RARP in elderly patients presenting with localized prostate cancer should be considered a viable treatment
alternative based on the individual’s life expectancy.
198
A. Gallina, M. Bianchi, E. Di Trapani, V. Cucchiara, C. Cozzarini, N. Di Muzio, V. Mirone, R. Damiano, F.
Cantiello, F. Montorsi, A. Briganti (Milano)
Aim of the study
NCCN and D’Amico risk classification are widely used in clinical practice, but were developed on historical
patients cohort. We aimed at developing and internally validating a novel clinically useful algorithm to
predict biochemical recurrence (BCR) among contemporary patients treated with RP for prostate cancer
(PCa).
The study population included 4,372 consecutive patients treated with RP for PCa between 1993 and 2012
at single a tertiary referral center. Clinical features (namely pre-operative PSA, biopsy Gleason score and
clinical stage) were employed to develop the novel model. Kaplan-Meier curves assessing BCR were used to
address statistically significant difference categories (defined as a p between each category 50%). Predictive
ability of the model was evaluated using the c (for concordance) index proposed by Harrell et al.
Results
In the overall population, the 5-, 8-, and 10 years BCR free survival rates were 88, 82 and 74%, respectively.
At multivariable Cox regression analyses, all variables included were significantly associated with BCR
(all p 20 ng/ml or GS 8-10 + PSA >10 + positive DRE or GS 4+3 + PSA >20 + DRE positive) vs. 8-10
(very high risk; GS 8-10, PSA >20 ng/mL and positive DRE, or those with GS 8-10 and PSA >50 ng/mL)
The accuracy of the model proposed was of 72.5%. When the D’Amico model was validated in the current
patient population, its accuracy was 59.7%.
Discussion
We developed a novel risk group classification for BCR prediction after RP for PCa. This includes 5
different categories from very low to very high risk of recurrence.
Conclusions
The model showed good predictive ability and might be useful to better sub-stratify the outcome of PCa
patients.
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PROSTATE HEALTH INDEX IS A PREOPERATIVE PREDICTOR OF EARLY BIOCHEMICAL
RECURRENCE IN PATIENTS WITH PROSTATE CANCER TREATED WITH RADICAL
PROSTATECTOMY AND BILATERAL LYMPH NODE DISSECTION
PROGNOSTIC ASSESSMENT OF NEOPLASTIC INVOLVEMENT OF THE PROSTATIC APEX IN
RADICAL PROSTATECTOMY.
G. Lughezzani, M. Lazzeri, A. Abrate, E. Kinzikeeva, F. Mistretta, N. Buffi, G. Lista, N. Fossati, A. Larcher,
G. Gadda, P. Dell’Oglio, G. Guazzoni (Milano)
Scopo del lavoro
In the last few years, prostate health index (PHI) levels has emerged as a promising biomarker to detect
prostate cancer (PCa) and to preoperatively determine its aggressiveness. The aim of this study was to
determine whether PHI could help to preoperatively predict early biochemical recurrence (BCR) in a
contemporary population of patients with PCa treated with robotassisted radical prostatectomy (RARP).
Materiali e metodi
The study population consisted of 313 patients treated with RARP and pelvic lymph node dissection for
clinically localized PCa at a single institution betw een 2010 and 2011. Patients subjected to neoadjuvant or
adjuvant therapies and patients with a follow -up
AIM OF THE STUDY
TO EVALUATE THE PROGNOSTIC ROLE OF PROSTATIC APEX TUMOR INVASION IN PATIENTS
UNDERGOING RADICAL PROSTATECTOMY FOR PROSTATE CANCER (PCA) CLINICALLY ORGAN CONFINED AND TO DEFINE ITS CORRELATION WITH CLINICAL AND PATHOLOGIC VARIABLES (AGE, CLINICAL STAGE, PREOPERATIVE PSA,% FRUSTULES POSITIVE BIOPSY, GLEASON SCORE, SURGICAL MARGIN STATUS).
MATERIALS AND METHODS
FROM OUR DATABASE OF 1693 PATIENTS WHO UNDERWENT RP BETWEEN 2000 AND 2012 FOR
CLINICALLY LOCALIZED PCA, DATA FROM 498 PATIENTS WITH PATHOLOGICAL STAGE T2
WERE RETROSPECTIVELY EVALUATED.
THE ENTIRE PROSTATE WAS EXAMINED WITH 2-4 MM INTERVALS TRANSECTIONS IN A PLANE
PERPENDICULAR TO THE URETHRA. THE APICAL PROSTATE WAS SEPARATELY SECTIONED
AND EXAMINED IN PARALLEL SLICES AND “APICAL INVOLVEMENT” WAS DEFINED AS THE
PRESENCE OF NEOPLASTIC GLANDS IN THE LAST 8 MM OF THE PROSTATE. PATIENTS WITH
LYMPH NODES INVOLVEMENT WERE TREATED WITH EARLY ADJUVANT HORMONAL THERAPY. BIOCHEMICAL RELAPSE WAS DEFINED AS THE EVIDENCE OF PSA > 0.2 NG/ML IN TWO
CONSECUTIVE MEASUREMENTS. THE PROBABILITY OF BIOCHEMICAL RECURRENCE WAS
ESTIMATED BY THE KAPLAN-MEIER METHOD, WITH THE LOG-RANK TEST USED TO EVALUATE DIFFERENCES AMONG LEVELS OF THE ANALYZED VARIABLES (APICAL INVOLVEMENT,
PREOPERATIVE PSA, GLEASON SCORE, PATHOLOGICAL STAGE, SURGICAL MARGINS STATUS). THE MULTIVARIATE COX PROPORTIONAL HAZARD MODEL WAS USED TO ESTIMATE
THE RELATIVE IMPORTANCE OF THE VARIABLES IN PREDICTING SURVIVAL.
RESULTS
OVERALL 280 PATIENTS ( 56.2 %) HAD NEOPLASTIC INVOLVEMENT OF THE PROSTATIC APEX.
THE MEAN FOLLOW-UP WAS 40 MONTHS (RANGE 6-154 ). IN 30 PATIENTS (6.02 %) A BIOCHEMICAL RELAPSE WAS OBSERVED, WITH A MEAN TIME OF 30 MONTHS (RANGE 3-149).
POSITIVE SURGICAL MARGINS WERE OBSERVED IN 34 PATIENTS (6.8 %), OF WHOM, 26 (76.4%)
PRESENTED THE INVOLVEMENT OF THE PROSTATIC APEX. THE NUMBER AND THE PERCENTAGE OVER THE TOTAL OF NEOPLASTIC BIOPSY CORES WERE PREDICTOR FACTORS OF TUMOR APEX INVOLVEMENT (P = 0.018).
THE BIOCHEMICAL RECURRENCE-FREE SURVIVAL (BRFS) FOR PATIENTS WITH POSITIVE
APEX WAS LOWER THAN IN PATIENTS WITH NEGATIVE APEX (91.9% VS 95.9 % AT 36 MONTHS
, 88 % VS 92.8 % AT 60 MONTHS AND 86% VS 92.8 % AT 120 MONTHS, RESPECTIVELY) ( P = 0.05).
POSITIVE SURGICAL MARGINS, THE APEX INVOLVEMENT AND PATHOLOGICAL STAGE WERE
SIGNIFICANTLY CORRELATE WITH BIOCHEMICAL RELAPSE AT UNIVARIATE ANALYSIS. MULTIVARIATE ANALYSIS CONFIRMED THE STATISTICAL INDEPENDENCE OF POSITIVE SURGICAL MARGINS (P = 0.0004 , RR = 5.17 ) AND APEX INVOLVEMENT (P = 0.0536 , RR = 2.47 ).
CONCLUSIONS.
THE PROSTATIC APEX REPRESENTS A CRUCIAL ANATOMICAL STRUCTURE DURING RADICAL
PROSTATECTOMY FOR BOTH ONCOLOGICAL AND FUNCTIONAL OUTCOMES. THE ABSENCE
OF A WELL ANATOMICALLY DEFINED CAPSULE AT THIS LEVEL SUPPOSE THE RISK OF UNDERSTAGING AT FINAL PATHOLOGICAL ANALYSIS. OUR DATA SHOWED THAT TUMOR INVASION INTO THE PROSTATIC APEX IS A SIGNIFICANT PROGNOSTIC FACTOR REGARDLESS OF
THE STATUS OF SURGICAL MARGINS
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Can the “cell cycle progression score” be considered a prognostic tool
in prostate cancer? Preliminary data in a large Italian site
SURVIVAL, CONTINENCE AND POTENCY (SCP) RECOVERY AFTER RADICAL
RETROPUBIC PROSTATECTOMY: A LONG-TERM COMBINED EVALUATION OF SURGICAL
OUTCOMES.
Bollito E.1, Manfredi M.2, Fiori C.2 , Poggio M.2, Cattaneo G.2, Garrou D.2, Amparore D., Aimar R. 2, Papotti M.1, Porpiglia F.2
1San Luigi Gonzaga Hospital, Dept. of Pathology, University of Turin, Orbassano, Italy, 2San Luigi
Gonzaga Hospital, Dept. of Urology, University of Turin, Orbassano, Italy
Introduction
Recently, some studies aimed in identifying prostate cancer (PCa) aggressiveness, were focused on
molecular analysis, using gene-profiling methods. We focused our interest on cell-cycle progression (CCP)
gene expression assay, developed and marketed by Myriad Genetics Laboratories (Salt Lake City, USA).
This CCP assay has been previously validated retrospectively in specimens following prostate surgery and,
more recently, on prostate biopsy specimens. In these studies, the CCP ScoreTM was shown to predict
the biochemical failure after radical prostatectomy and PCa specific mortality. In this preliminary study,
we assessed the CCP score data in an Italian case series, evaluating the distribution of the score and his
correlation with other prognostic factors.
Material & Methods
An open-label, observational study was started on January 2013 at our Institution, after IEC/IRB approval.
Ninety-four patients with localized PCa confirmed by biopsy were enrolled. The CCP score was performed
measuring the expression of 31 genes involved in CCP in combination with 15 housekeeping genes with
quantitative RT-PCR on RNA extracted from formalin-fixed paraffin-embedded tumor samples on prostate
biopsy. All tests were carried out at Myriad Genetic Laboratories and a CCP score, derived from the ratio
between normal and abnormal genes, was calculated for each case. Scores ranging between -1.3 to 4.7 were
expected by this assay. Finally we assessed the association of CCP score with other prognostic factors.
Results
Nowadays 84 out of 94 patients (89.4%) have completed CCP scores (final results awaited), of whom 51
patients (61%) underwent radical prostatectomy. Median CCP score was -0.3 (IQR: -0.7; 0.2). Median CCP
score was significantly different according to clinical stage (Kruskal-Wallis p=0.012) and Gleason score
(p=0.020), while was not different according to margin status (p=0.074) and pathological stage (p=0.345).
Conversely, no significant (p<0.05) correlations were found between Prolaris and age (r Spearman=0.31
p=0.060), % positive cores (r=0.25 p=0.117),
tumor volume (r=0.14 p=0.523) or PSA (r=-0.02 p=0.765). Based on the CCP scores, 14.3% of patients
presented a less aggressive PCa compared to AUA risk classification, while 35.7% a more aggressive PCa.
Discussion
Notwithstanding the small sample size and the preliminary data of this study, our results seems to
demonstrate that the CCP score is significantly related to the clinical stage of PCa and the GS at biopsy.
Conclusions
The test improves risk stratification in 50% of patients when compared to AUA risk classification. The study
is ongoing and more data are expected.
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M. Borghesi, R. Schiavina, C. Pultrone, H. Dababneh, V. Vagnoni, G. Gentile, L. Bianchi, B. Longhi, L.
Della Mora, S. Rizzi, M. Garofalo, S. Concetti, E. Brunocilla, G. Martorana (Bologna)
Aim of the study
A large amount of the new prostate cancer (PCa) cases are being detected in younger and healthier patients,
often in clinically localized stage. The first objective of radical prostatectomy (RP) is cancer control.
However, a fast and complete functional recovery should be attained especially in younger patients. To
date, only few studies report together the survival, continence and potency recovery rates after RP for PCa.
Survival, Continence and Potency (SCP) classification has been recently proposed with the aim to offer not
only a more realistic interpretation of the outcomes, but also being more applicable in the real life scenario.
Aim of our study was to offer a comprehensive account of surgical outcomes on a defined series of patients
treated with radical retropubic prostatectomy (RRP) for prostate cancer in a single European Center after
5-year minimum follow-up according to the SCP system.
We evaluated our Institutional database of 778 consecutive patients who underwent RRP from November
1995 to September 2008. Biochemical disease-free survival (S), urinary continence (C) and potency
recovery (P) were classified according to SCP system. In details, the S category is subdivided into three
different groups: (1) patients treated with adjuvant therapies (Sx), (2) patients without PSA recurrence (S0),
and (3) patients with PSA > 0.2 ng/ml (S1). The C category is subdivided into (1) patients not using a pad
(C0), (2) patients using one pad for security (C1), and (3) patients using > 1 pad (C2). Cx category is used
for patients who were not evaluable because of preoperative incontinence. P category is subdivided into (1)
patients not evaluable (Px), (2) patients potent without any aids (P0), and (3) patients potent with erectile
aids (P1) or patients impotent (P2).
Results
The 5- and 10-year biochemical recurrence-free survival rates were 80.1% and 55.8%, respectively. At the
end of follow-up, 611 (78.5%) patients were fully continent (C0), 107 (13.8 %) used 1 pad for security (C1)
and 60 (7.7%) patients were incontinent (C2). Of the 112 patients who underwent nerve-sparing RRP, 22
(19.6%) were fully potent without aids (P0), 13 (11.6%) were potent with assumption of PDE-5 inhibitors
(P1) and 77 (68.8%) experienced erectile dysfunction (P2). The combined SCP outcomes were reported
together only in 95 (12.2%) evaluable patients. In patients preoperatively continent and potent, who received
a nerve-sparing and did not require adjuvant therapy, oncological and functional success was attained by 29
(30.5%) patients. (Fig. 1a) In the subgroup of 508 patients not evaluable for potency recovery, oncological
and continence outcomes were obtained in 357 patients (70.3%). (Figure 1b).
Discussion
.
Conclusions
SCP classification offer a comprehensive report of surgical results, even in those patients who do not
represent the “best” category, thus allowing to provide a much more accurate evaluation of outcomes after
RP.
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THE IMPACT OF TIME TO BIOCHEMICAL RECURRENCE ON CANCER-SPECIFIC
MORTALITY IN PATIENTS WITH HIGH-RISK PROSTATE CANCER TREATED WITH
RADICAL PROSTATECTOMY: A COMPETING-RISKS REGRESSION ANALYSIS
EFFECTS OF POLLEN EXTRACT IN ASSOCIATION WITH VITAMINS (DEPROX 500®) FOR
PAIN RELIEF IN PATIENTS AFFECTED BY CHRONIC PROSTATITIS/CHRONIC PELVIC PAIN
SYNDROME: RESULTS FROM RANDOMIZED, CONTROLLED STUDY.
G. Gandaglia, M. Spahn, S. Joniau, P. Gontero, M. Bianchi, B. Kneitz, F. Chun, M. Sun, M. Graefen, F.
Abdollah, G. Marchioro, D. Frohenberg, S. Giona, B. Frea, P. Karakiewicz, H. Van Poppel, R. Karnes, F.
Montorsi, A. Briganti (Milano)
T. Cai, D. Tiscione, L. Luciani, G. Malossini, R. Bartoletti (Trento)
Aim of the study
Previous studies reported contrasting results regarding the association between time to biochemical
recurrence (BCR) and the risk of dying from prostate cancer (PCa) after radical prostatectomy (RP). Of note,
none of them accounted for the risk of other causes mortality. This is crucial, given the protracted natural
history of the disease. To address this issue and to overcome this limitation, we aimed at evaluating the
impact of time to BCR on cancer-specific mortality (CSM) relying on competing-risks regression analyses in
men with high risk PCa.
Using a multi-institutional cohort, 2,065 patients treated with RP for high-risk PCa defined according to the
NCCN guidelines (clinical stage ≥T3 and/or biopsy Gleason score 8-10 and/or preoperative PSA ≥20ng/
ml) between 1991 and 2011 were identified. No patient received neo-adjuvant or adjuvant therapy. BCR was
defined as two consecutive PSA values ≥0.20ng/ml after RP. For the purpose of our analyses, we included
only patients who experienced BCR after surgery (n=823). First, we dichotomized time from surgery to
BCR according to the most informative cut-off predicting CSM. Second, cumulative incidence CSM rates
were then generated according to the dichotomized time to BCR and compared with the Gray test. Finally,
multivariate competing-risks regression models were used to test the effect of time from surgery to BCR on
the risk of dying from PCa after accounting for the risk of dying from other causes.
Results
The average age at surgery was 64.5 years (median 65). Median follow-up was 109 months (median: 111.3).
The overall 5- and 10-year CSM were 6.3 (95% confidence interval [CI]: 4.6-8.9%) and 14.8% (95% CI:
16.3-24.4%), respectively. The most informative cut-off for time from RP to BCR in predicting CSM was 35
months (P
Discussion
The time elapsed between surgery and BCR represents an independent predictor of CSM in patients with
high-risk PCa treated with RP. Patients recurring within 3 years from surgery might benefit from more
aggressive, multimodal treatments. Conversely, those experiencing a late BCR should be considered at lowrisk of subsequent CSM.
Aim of the study
The therapeutic efficacy of CP/CPPS is not very satisfactory and the impact on young male quality of life
is considerable. The aim of the present study is to evaluate the efficacy of pollen extract assocaited with
vitamins (DEPROX 500®) in order to improve the quality of life of young patients affected by chronic
prostatitis (CP/CPPS) by pain relieving.
All patients with clinical and instrumental diagnosis of CP/CPPS (class a or b), attending the same
urologic centre, from March to October 2012, were enrolled in this prospective, randomised phase 3 study
comparing the pollen extract associated with vitamins (DEPROX 500®) to nonsteroidal anti-inflammatory
drugs (NSAIDs). Participants were randomised to receive oral capsules of DEPROX 500® (two capsules
q24h) or NSAIDs for 4 wk. Clinical and microbiological analyses were carried out at the enrolment and
after 1 month. NIH-CPSI and IPSS questionnaires have been used. The main outcome measure was the
improvement of quality of life at the end of the whole study period, evaluated by questionnaires results.
Results
78 (mean age 32.8 ±6.78) men were randomly allocated to the pollen extract (DEPROX 500®) (n=38) or
NSAIDs (n=40). The baseline questionnaire mean scores were 25.90 ±2.1 and 8.01 ±3.64 for NIH-CPSI and
IPSS, respectively. At the follow-up examination (1 month after treatment), in the DEPROX 500® group,
31 out of 38 patients (81.5%) reported an improvement of quality of life, in terms of pain reduction, while
19 out of 40 (47.5%) in the control group. The questionnaire results after 1 month from treatment were as
follows: NIH-CPSI 12.8 ±2.20, IPSS 7.6 ±1.58 DEPROX 500® group; NIH-CPSI 19.5 ±2.10, IPSS 8.00
±2.81 control group. Statistically significant differences were then reported between the two visits, in terms
of NIH-CPSI scores (p
Discussion
The therapeutic effect of DEPROX on pain in patients with CP/CPPS may be related to its antioxidant effect
and to its nerve protective action. In fact, the most important vitamins in nerve regeneration are the vitamin
B complex, particularly thiamin, pantothenic acid, vitamin B-6 and B-12.
Conclusions
The pollen extract associated with vitamins (DEPROX 500®) significantly improved total symptoms, pain,
and QoL in patients with CP/CPPS without severe side-effects, when compared to NSAIDs.
Conclusions
Such information can help provide patients and physicians with better follow-up protocols and treatment
strategies for the postoperative management of recurring high-risk PCa patients.
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RELAZIONE TRA PSA E CARDIOPATIA ISCHEMICA
SERENOA REPENS, LICOPENE E SELENIUM VS. TAMSULOSINA PER IL TRATTAMENTO
DEI LUTS: UNO STUDIO ITALIANO MULTICENTRICO RANDOMIZZATO COMPARATIVO
TRA LA MONOTERAPIA O LA COMBINAZIONE (PROCOMB STUDY)
R. Manco, A. Gioia, R. Castellucci, P. Castellan, M. Ingrosso, P. De Francesco, M. Marchioni, R. Tenaglia
(Chieti)
Scopo del lavoro
Il dosaggio del PSA (prostate-specific antigen), che viene utilizzato per monitorare l’andamento delle
patologie prostatiche, è stato associato alla prognosi di patologie coronariche acute. Lo scopo del nostro
studio è stato valutare la relazione tra i valori ematici di PSA e la presenza di pregressi eventi ischemici
cardiovascolari.
Materiali e metodi
Abbiamo condotto uno studio retrospettivo su 330 uomini, di età compresa tra 49 e 79 anni, sottoposti a
prelievo ematico per il dosaggio di PSA. Sono stati valutati età, peso, altezza, razza, tabagismo, pressione
arteriosa, dislipidemie e patologie concomitanti. Tutti i pazienti sono stati sottoposti ad esplorazione rettale
e a ECG basale. Criteri di esclusione sono stati: esplorazione rettale positiva per sospetta neoplasia, pazienti
con anamnesi positiva per LUTS (disturbi delle basse vie urinarie) o cancro prostatico o ipertrofia prostatica
benigna, terapia farmacologica con statine. Dei 330 pazienti, 117 sono risultati idonei per il nostro studio.
Risultati
Dei 117 pazienti, 43 (36,7 %) presentavano all’ECG un pregresso infarto; 20 pazienti (17%) presentavano
lievi anomalie (es. blocco di branca); 54 pazienti (46,1%) mostravano un ECG nella norma. I pazienti con
ECG normale avevano un PSA medio di 2,1 + 2,1 ng/ml (p < 0,05) con esplorazione rettale negativa; i
pazienti con lievi anomalie presentavano un PSA medio di 3,3 + 1,5 ng/ml (p < 0,05) ; i pazienti con ECG
che mostrava un pregresso infarto (IMA), avevano un PSA medio di 7,7 + 1,9 ng/ml (p
Discussione
Recenti studi hanno dimostrato che potrebbe esserci un’associazione tra il PSA e le sindromi coronariche
acute. Il PSA aumenta il rilascio dell’IGF-1 (insulin like growth factor-1), che aumenta il rischio di sviluppo
di infarto. Nel nostro studio valutiamo la relazione tra i livelli ematici di PSA e la presenza di pregressi
eventi ischemici cardiologici. I criteri necessari per la diagnosi di pregresso IMA sono: - Sviluppo di
patologiche onde Q, precedentementi non presenti, in seriali ECG. I markers sierici di necrosi possono
essere normali e il paziente può non riferire sintomi. Nel nostro studio è risultato un aumento significativo
del PSA nei pazienti con pregresso IMA. Non ci sono state significative correlazioni tra il valore del PSA e
soggetti con ECG normale o con ECG con lievi anomalie.
G. Morgia, G. Russo, S. Voce, F. Palmieri, M. Gentile, A. Giannantoni, F. Blefari, M. Carini, A. Minervini,
A. Ginepri, G. Salvia, G. Vespasiani, S. Cimino, R. Allegro, Z. Collura, E. Fragalà, S. Arnone, R. Pareo
(Catania)
Scopo del lavoro
L’Iperplasia Prostatica Benigna (IPB) è una delle cause più frequenti di sintomi delle basse vie urinarie
(LUTS) negli uomini. Il seguente studio multicentrico, randomizzato, doppio-cieco, doppio dummy si pone
come obiettivo quello di valutare l’efficacia della terapia di combinazione con Serenoa Repens, Selenium,
Licopene + tamsulosina versus le singole monoterapie nel trattamento dei LUTS ad 1 anno di follow-up.
Materiali e metodi
Da marzo 2011 a marzo 2012, 225 pazienti provenienti da 11 centri italiani sono stati arruolati in questo
studio randomizzato, in doppio cieco. I criteri erano: età tra 55 e 80 anni, PSA ≤ 4 ng / ml, IPSS ≥ 12,
volume prostatico ≤ 60 cc, Qmax ≤ 15 ml/s, residuo post-minzionale (RPM)
Discussione
E’ possibile supporre cha la terapia di combinazione sia in grado di massimizzare gli effetti di ciascuna
classe di farmaco, la tamsulosina attraverso il blocco del recettore α1-adrenergico e la Ser-Se-Ly attraverso
l’effetto anti-infiammatorio e pro-apoptotico.
Conclusioni
In questo studio multicentrico, randomizzato, doppio cieco studio, la terapia di combinazione con Ser-SeLy + tamsulosina 0,4 mg per 1 anno è risultata più efficace rispetto alle singole monoterapie in termini di
riduzione dell’IPSS e in termini di aumento del Qmax nei pazienti affetti da LUTS/IPB.
Conclusioni
I dati del nostro studio evidenziano una relazione significativa tra aumento del PSA e pregressi eventi
ischemici cardiovascolari.
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TERAPIA CON DUTASTERIDE 0.5 MG PRECEDUTA DA TADALAFIL 5 MG NEL
TRATTAMENTO DEI LUTS DA IPB: PUNTIAMO SUL TRATTAMENTO SEQUENZIALE PER
AUMENTARE LA COMPLIANCE
THE MEDICAL TREATMENT OF BENIGN PROSTATIC HYPERPLASIA EFFECTIVENESS
AND DRUG ADHERENCE: RESULTS FROM A RECORD-LINKAGE ANALYSIS
G. Malossini, T. Cai, P. Verze, D. Tiscione, A. Scardigli, V. Mirone, R. Bartoletti (Trento)
Scopo del lavoro
Scopo del presente lavoro è la valutazione dell’efficacia della terapia sequenziale con tadalafil 5 mg seguita
da dutasteride 0.5 mg nella riduzione degli AEs della sfera sessuale dei pazienti affetti da LUTS da IPB.
Materiali e metodi
Dal Luglio 2013 all’Ottobre 2014, 31 pazienti con LUTS da IPB (età mediana 63, range 61-71), candidati
alla terapia medica con inibitori della 5-alfa-reduttasi, sono stati sottoposti a terapia sequenziale con tadalafil
5 mg 1 cpr al dì per 30 giorni, poi associata a dutasteride 0.5 mg 1 cpr al dì. Tale coorte di pazienti è stata
confrontata con un gruppo di 39 pazienti sottoposti a terapia con dutasteride 5 mg. La diagnosi di LUTS
è stata eseguita secondo le linee guida EAU; ad ogni paziente sono stati sottoposti i seguenti questionari:
IPSS, IIEF-5 all’arruolamento e dopo 6 mesi. Inoltre sono stati indagati gli AEs sulla sfera sessuale.
Dall’analisi sono stati esclusi tutti i pazienti con: terapia al bisogno con 5PDEi e quelli già sottoposti a
trattamento chirurgico per LUTS da IPB. Ogni paziente è stato rivalutato a 6 mesi.
Risultati
I due gruppi erano omogenei in termini di caratteristiche cliniche e strumentali (IPSS 18.3±5.9; IIEF-5
15.1±4.7 vs IPSS 18.4±4.6; IIEF-5 15.0±3.9). A 6 mesi dopo il trattamento i due gruppi erano omogenei
in termini di efficacia terapeutica sui LUTS, anche se il gruppo con tadalafil 5 mg + dutasteride 0.5 mg
presentava dei valori di IPSS maggiori, sebbene non statisticamente significativi. I due gruppi erano
statisticamente diversi in termini di frequenza di effetti collaterali sulla sfera sessuale [calo desiderio:
3/31 (9.6%) nel gruppo tadalafil + dutasteride vs 4/39 (10.2%) nei controlli (p=0.03); IIEF-5 20.1±3.3 vs
15.6±3.8) (p<0.001)].
Discussione
La terapia con inibitori della 5-alfa-reduttasi rappresenta uno dei pilatri del management dei pazienti con
LUTS da IPB, con una frequenza di eventi avversi (AEs) sulla sfera sessuale inferiore al 10%. Un recente
studio ha dimostrato come l’associazione della terapia con tadalafil 5 mg con finasteride 5 mg è in grado di
ridurre la frequenza degli AEs ed aumentare la compliance dei pazienti.
L. Cindolo (Vasto)
Aim of the study
Randomized trials have shown the efficacy of medical treatment of benign prostatic hyperplasia (BPH).
Few data exists on effectiveness and drug adherence in real life. To examine effectiveness and adherence to
pharmacological therapy using a record-linkage analysis in a large cohort of Italian patients.
A retrospective cohort analysis was carried out, using prescription administrative database and hospital
discharge codes from 1.5 million patients. Records of male ≥40years, who were prescribed alpha-blockers
(AB) and 5alpha-reductase inhibitors (5ARI) either monotherapy or in combination (CT) were identified
between January 2004-December 2006 (index period). Main Outcomes and Measures- 1–year and long-term
adherence to prescribed treatment; hospitalization rates for BPH and BPH surgery in treated patients.
Results
In men who received prescription for at least 6-months the 1-year adherence was 29%. Patients who
remained under medical therapy for the entire follow-up period (median 4-years) represented the 13% of
those identified in the index period. Patients on CT had a higher discontinuation rate in the first 2-years
compared to those on monotherapy (70% AB, 59% 5ARI, 34% CT, p<.0001).
Discussion
The long term use of 5ARI and CT was associated with an independent reduced risk of hospitalization for
BPH surgery.
Conclusions
Adherence to the pharmaceutical treatment of BPH is low and reduces drug effectiveness. Results of the
current analysis confirm the effectiveness of medical treatment of BPH observed in randomized clinical trial,
but suggest the need of new strategies to increase adherence to the prescribed treatment.
Conclusioni
Il presente studio dimostra come la terapia con tadalafil 5 mg precedente alla terapia con dutasteride 0.5
mg è in grado di ridurre gli effetti collaterali sulla sfera sessuale nei pazienti affetti da LUTS da IPB, che
comunque resta bassa. Tale studio, sebbene caratterizzato da alcune limitazioni, può essere la base per lo
sviluppo di studi futuri.
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UTILIZZO PROLUNGATO DI ALFA-LITICI: QUALI EFFETTI SULLA MUSCOLATURA
IRIDEA?
WHEN TO PERFORM PRESSURE FLOW STUDY IN PATIENTS WITH LOWER URINARY
TRACT SYMPTOMS AND BENIGN PROSTATIC ENLARGEMENT: EXTERNAL VALIDATION
OF A NOVEL CLINICAL NOMOGRAM
P. Saldutto, S. Masciovecchio , M. Lanciotti, D. Biferi , V. Galica, E. Toska, G. Paradiso Galatioto, C.
Vicentini (L’Aquila)
Scopo del lavoro
La Sindrome dell’iride a bandiera (Intraoperative Floppy Iris Syndrome-IFIS) è uno dei possibili effetti
avversi attribuibile all’utilizzo prolungato dei farmaci alfa-litici. IFIS si associa ad un incremento di
complicanze in corso di chirurgia oftalmologica per cataratta. Scopo del nostro studio è stato quello di
comparare gli effetti dell’utilizzo di Tamsulosina e Silodosina sull’attività del muscolo costrittore dell’iride.
Materiali e metodi
Abbiamo reclutato per lo studio 58 pazienti affetti da LUTS in terapia esclusivamente con alfa-litici da
almeno 24 mesi di cui 32 in trattamento con Tamsulosina 0,4 mg die ( Gruppo A) e 26 in terapia con
Silodosina 8 mg die (Gruppo B). Tutti i pazienti reclutati sono stati sottoposti alla instillazione congiuntivale
di collirio midriatico (Tropicamide 1%) con successiva valutazione, a 10 minuti, del diametro pupillare
verticale mediante l’utilizzo di una lampada a fessura.
Risultati
L’età media dei pazienti appartenenti al Gruppo A è stata di 71 anni ed il tempo medio di trattamento con
Tamsulosina di 4,6 anni; l’età media dei pazienti appartenenti al Gruppo B è stata di 67 anni ed il tempo
medio di assunzione di Silodosina pari a 3,1 anni. Il diametro pupillare mediano ottenuto per i pazienti del
Gruppo A è stato 6,4 mm (5,9-6,5) e quello ottenuto per il Gruppo B di 7,2 mm (7-7,4).
Discussione
IFIS è una sindrome relativamente rara riportata in circa il 2% degli interventi eseguiti per cataratta,
associata all’aumentato rischio di complicanze intraoperatorie quali trauma e prolasso irideo, miosi
pupillare, aspirazione iridea, lesioni della capsula posteriore del cristallino e perdita del vitreo. L’utilizzo di
farmaci ad attività alfa antagonista nel trattamento dei LUTS correla con l’insorgenza di tale sindrome. Non
vi sono studi in letteratura che abbiano comparato gli effetti a lungo termine di Tamsulosina e Silodosina sul
muscolo costrittore dell’iride. La nostra esperienza ha evidenziato che la Silodosina preserva maggiormente
la funzionalità della muscolatura iridea rispetto a Tamsulosina.
Conclusioni
Seppur nei limiti dell’esigua numerosità del campione la nostra esperienza ha evidenziato che l’assunzione
di Silodosina si associa ad un minor danno atrofico da inutilizzo della muscolatura iridea.
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F. Presicce, C. De Nunzio, A. Trucchi, R. Lombardo, M. Gacci, M. Carini, C. Pellegrino, A. Cantiani, A.
Tubaro (Roma)
Aim of the study
Recently the Young Academic Urologist-BPH group developed a clinical nomogram for the prediction
of benign prostatic obstruction (BPO) in patients with lower urinary tract symptoms (LUTS) and benign
prostatic enlargement (BPE) (Figure 1). Aim of our study was to externally validate the YAU-BPH
nomogram for the prediction of BPO in patients with LUTS/BPE.
Between January -September 2013, a consecutive series of patients with LUTS and BPE underwent
standardized pressure flow studies (PFS) before considering transurethral surgery. Variables assessed were
IPSS, PSA, prostate size, transitional zone volume (TZV), maximal urinary flow rate (Qmax), post void
residual urine (PVR). Benign prostatic obstruction was defined as a Schaefer grade ≥3 at PFS. Qmx, TZV
were plotted on the YAU-BPH nomogram to predict the presence of BPO. Receiver-operator characteristics
(ROC) curve analysis was used to evaluate predictive properties of the nomogram for the final diagnosis of
BPO.
Results
A total of 342 patients were consecutively enrolled. Median age was 66 (IQR: 60/71) years, median IPSS
was 15 (IQR: 10/19), median BMI was 26 (IQR: 24/29) kg/m2. Median prostate volume and TZV were
respectively: 50 cc (IQR: 36/70) and 24 cc (IQR: 15-35); median Qmax was: 9.4 ml/sec (IQR: 7/12.6). 262
patients (76.6%)presented a BPO (Schaefer >3 ) at PFS. The novel YAU-BPH nomorgram presented an
AUC of 0.65; 95%CI: 0.58- 0.71 for the diagnosis of BPO. At the best cut-off value of 80% (nomogram
probability) the sensitivity was 0.65 and specificity was 0.77, the positive predictive value was 88% and the
negative predictive value was 32%.
Discussion
In our experience the YAU-BPH nomogram is an easy tool for the diagnosis of BPO in patients with LUTS/
BPE with a good accuracy (AUC: 0.65) and an excellent PPV (88%).
Conclusions
Although further multicenter studies are needed to confirm our results, the implementation of the YAU-BPH
nomogram, in our experience could reduce the number of unnecessary PFSs.
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18F-FACBC COMPARED WITH 11C-CHOLINE PET/CT IN PATIENTS WITH BIOCHEMICAL
RELAPSE AFTER RADICAL PROSTATECTOMY: A PROSPECTIVE STUDY IN 79 PATIENTS.
ACCURACY OF P2PSA AND DERIVATIVES (%P2PSA AND PHI) IN PREDICTING PROSTATE
CANCER IN OBESE MEN FROM A MULTICENTER EUROPEAN STUDY
R. Schiavina, C. Pultrone, L. Zanoni, C. Nanni, M. Borghesi, V. Vagnoni, G. Passaretti, L. Bianchi, G.
Gentile, C. Del Prete, S. Fanti, G. Martorana, E. Brunocilla (Bologna)
A. Abrate, M. Lazzeri, N. Buffi, G. Lughezzani, V. Bini, A. Haese, A. de la Taille, T. Mc Nicholas, J. Palou
Redorta, G. Gadda, G. Lista, E. Kinzikeeva, N. Fossati, A. Larcher, P. Dell’Oglio, F. Mistretta, M. Freschi,
G. Guazzoni (Milano)
Aim of the study
Approximately 40% of patients managed with radical treatment for localized prostate cancer
(PCa) will develop biochemical relapse. Recently, a synthetic L-leucine analogue, anti-1-amino-318F-fluorocyclobutane-1-carboxylic acid (anti-3-18F-FACBC) has been proposed as a promising
radiopharmaceutical agent to detect PCa recurrences, alternative to 11C-choline. The aim of our study was
to compare the detection rate (DR) of 18F-FACBC PET/CT in comparison with 11C-choline PET/CT in the
evaluation of disease recurrence of PCa after radical treatment.
79 consecutive patients with biochemical relapse after radical treatment for PCa were submitted to
18FFACBC PET/CT and 11C-choline PET/CT to evaluate the site of disease recurrence. Androgen
deprivation therapy was avoided in all cases. The results of the two test were compared in terms of DR both
on a patient and lesion basis.
Results
In patient-based analyses, 11C-choline PET/CT was positive in 23 patients and negative in 56 (detection
rate 29,1%) and 18F-FACBC PET/CT was positive in 30 patients and negative in 49 (detection rate 37,9%).
There was a statistical significant difference in terms of number of positive scans between 18F-FACBC and
11C-Choline (Fisher’s exact test p
Discussion
Although the natural history of recurrent PCa is often one of slowly progressing disease, in some men it can
be rapid and might need salvage treatment. Prostatic bed, pelvic or retroperitoneal lymph nodes and bones
are the sites where we must focus our attention in the early phase of PSA relapse. Conventional imaging
is inappropriate to detect disease relapse: when a disease relapse is detected using conventional imaging,
PSA and PSA kinetic characteristics are too high. In recent years, choline PET/CT has been demonstrated
to have better accuracy than conventional imaging. However, the detection rate of 11C-choline PET/CT
is still suboptimal. Very recently, the investigational imaging agent anti-3-18F-FACBC was proposed as
a possible alternative radiopharmaceutical agent to detect PCa relapse. Anti-3-18F-FACBC demonstrated
better detection than choline PET/CT and it detected a significantly greater number of lesions. None of the
11C-choline positive lesions were negative using anti-3-18FFACBC, demonstrating a non-inferiority of this
new compound.
Scopo del lavoro
Obesity is becoming highly prevalent all around the world. Its link with prostate cancer (PCa) is
controversial, although it seems associated with increased risk of high-grade Gleason Score (GS) at biopsy.
Even if PSA accuracy is not affected by BMI, it remains low. In this study, we tested the hypothesis that [-2]
proPSA (p2PSA) and derivatives (%p2PSA and PHI)are more accurate than tPSAin predicting PCa in obese
men (BMI ≥ 30).
Materiali e metodi
The analysis consisted of a nested case-control study from the PRO-psa Multicentric European Study
(PROMEtheuS) project (ISRCTN04707454). The primary outcome was to test sensitivity, specificity and
accuracy of serum p2PSA, %p2PSA ([(p2PSA pg/ml)/(fPSA ng/ml · 1000)] · 100) and Beckman Coulter
PHI ((p2PSA/fPSA) · √PSA), in identifying PCa in obese (BMI ≥ 30) men (clinical validity), and the
number of un-necessary biopsies, which could be avoided (clinical utility). Multivariable logistic regression
models were complemented by predictive accuracy analysis and decision curve analysis.
Risultati
Over 965 subjects, 383 (39.7%) were normal-weight (BMI < 25), 440 (45.6%) were overweight (BMI 2529.9) and 142 (14.7%)were obese patients (BMI ≥ 30). Within obese group, PCa was found in 65 subjects
(45.8%), 21 with GS 6 (32.3%), 26 with GS 7 (40.0%), and 6, 10 and 2 with GS 8, 9 and 10 (9.2, 15.4 and
3.1%) respectively. PSA, p2PSA, %p2PSA and PHI were significantly higher, and %fPSA significantly
lower in patients with PCa (p
Discussione
The strength of our study is its prospective, observational, multicentre European design. This study appears
to be the first in which p2PSA was prospectively evaluated according to BMI. Limitations: patients were all
included for their risk of PCa; we did not consider other parameters of body fat.
Conclusioni
In obese patients, %p2PSA and PHI values are significantly and even more accurate than the currently used
tests in determining the presence of PCa and could avoid unnecessary biopsies w ithout missing significant
PCa.
Conclusions
In our experimental condition 18F-FACBC provides a statistically better performance in terms of lesion
DR compared to 11C-Choline. More studies are required to evaluate the clinical significance in terms of
sensitivity, specificity and accuracy.
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MAGNETIC RESONANCE SPECTROSCOPIC IMAGING 3T without endorectal coil AND
PROSTATE CANCER: CORRELATION WITH TRANSPERINEAL ULTRASOUND GUIDED
PROSTATE BIOPSY
OBJECTIVE
CARDIOVASCULAR RISK AND PROSTATE CANCER: A POSSIBLE LINK TO PROSTATE
CANCER AGGRESSIVENESS
Aim of the study: The aim of our prospective study was to correlate the results obtained by Magnetic
Resonance Spettroscopy Imaging 3 tesla (3T MRSI) with those obtained by histological examination of
samples of the trans-perineal ultrasound-guided prostate biopsy (TPUS-B). In particular, we verified the
presence of prostate cancer (PCa) in areas with changes in the relationship (Cho + Cr)/Cit.
Materials and methods: 34 patients, mean age 67aa, were enrolled in the study. All patients had a clinical
suspicion of cancer due to increased PSA and/or positive digital rectal examination (DRE)
Patients were subjected to an MRSI 3T examination without endorectal coil, and within the following two
weeks, to TPUS-B. The results of the 3T MRSI were examined by experienced radiologists and compared
with the histologic findings.
Results: The average age of patients was 67 years (range 45-80) and the average PSA value was 7.87 ng/
ml (range of 4-40 ng7ml). 13 of 34 patients had a suspicious DRE, and 11 patients had a suspicious area for
PCa on TRUS.
Of the 22 patients who presented abnormalities MRSI at 3T, 9 had a histological diagnosis of Prostate
adenocarcinoma (ADK). Of the remaining 13 patients, 6 were found to be histologically positive for
Benign Prostatic Hypertrophy (BPH) and 7 Chronic Interstitial Inflammation (CII) or High Grade Prostatic
Intraepithelial Neoplasia (HG-PIN).
12 patients found to have no peripheral alterations in their prostate on 3T MRSI, none were positive for
ADK or inflammation on histology.
Specifically, we found in the peripheral portion of the gland, 77 voxels altered. Of these, 21 cases (27.2%)
showed BPH on histology. Of the remaining 72.8% (56 of 77) with abnormal prostate tissue 73.2% (41 of
56) were positive for ADK and 26.8% (15 of 56) for CII or HG PIN.
The Gleason Score (GS) ranged from 5 to 9, in particular, 3 patients had GS 5 (3 +2), 2 had G.S. 6 (3 +3), 1
G.S. 7 (4 +3), 1 G.S. 8 (4 +4) and 2 G.S. 9 (4 +5).
The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were
respectively100%, 48%, 40% and 100% respectively.
from 3T MRSI with the results of histologically
Discussion: In this study, we correlated the values obtained

examined prostate biopsies.
Our work shows that 72.8% of the voxels in which there was a change in ratio of (Cho + Cr)/Cit,
corresponded to areas of prostate tissue disease. Of these, 73.2% were positive for ADK and 26.8% for
CII or HG PIN. In literature, it is noted that PCa can be distinguished from areas of benign tissue, in the
the ratio (Cho + Cr)/Cit (17), although some benign conditions,
peripheral zone, on the basis of the values of
such as prostatitis or PINHG, can alter these values (18-19).

F. Presicce, C. De Nunzio, G. Truscelli, H. Fattahi, G. Giordano, R. Lombardo, C. Leonardo, B. Mariangela,
C. Fabiana, C. Gaudio, A. Tubaro (Roma)
Aim of the study
A possible relationship between prostate cancer and metabolic abnormalities has been recently proposed.
Furthermore, when concomitantly present, blood pressure and metabolic risk factors potentiate each other,
leading to a total cardiovascular risk which is greater than the sum of its individual components. Aim of our
study was to evaluate the association between cardiovascular risk and prostate cancer diagnosis and grade
among a consecutive series of men undergoing prostate biopsy.
From 2010 onwards, a consecutive men undergoing 12-core prostate biopsy at one center in Italy were
enrolled into a prospective database. Indications for a prostatic biopsy were a PSA value ≥ 4 ng/ml and/or
a positive digital rectal examination (DRE). Body mass index (BMI), as well as waist circumferences were
measured before the biopsy. Blood samples were collected before biopsy and tested for: total and free PSA
levels, fasting glucose, triglycerides and HDLs. Blood pressure was also recorded. Metabolic syndrome
was also defined according to the Adult Treatment Panel III (ATPIII). We evaluated the association between
cardiovascular risk (CVR) defined according to European Association of Cardiology Guidelines 2007 and
prostate cancer risk and biopsy Gleason score using logistic regression analyses.
Results
580 patients were enrolled with a median (IQR) age and PSA of 68 (61/74) years and 5.7 (4/8) ng/ml
respectively. Median BMI was 27.3 (25.2/29.7) k/m2 with 138 patients (23.7%) being classified as obese
(BMI ≥30 k/m2). 219 pts (37.7%) had MS. 406 pts (70%) presented a moderate/severe CVR. 236 patients
(40.6%) had cancer on biopsy; 157 (66%) with moderate/severe CVR and 79 (34%) with low/no CVR
(p= 0.20). PSA was independently associated with higher risk of cancer (OR 1.071 per 1 unit PSA; CI:
1.033-1.111, p=0.01). Out of 236 patients with prostate cancer, 113 (49%) had Gleason score 6 [65 (57%)
presented a low/no CVR] and 123 (52%) a Gleason score ≥7 [92 (75%) presented a moderate/severe CVR].
The presence of moderate/severe CVR was not associated with an increased risk prostate cancer (OR: 1.380,
CI: 0.886-2.149; p=0.154) but with an increased risk of Gleason ≥7 (OR: 2.082; CI: 1.036-4.181; p= 0.031).
Discussion
In our single center study, patients with a moderate/severe cardiovascular risk are associated with an
increased risk of high grade Gleason score when prostate cancer is diagnosed on biopsy. Although these
results should be confirmed in a larger multicenter study, patients with moderate/severe CVR should be
carefully evaluated for prostate cancer diagnosis.
Conclusions
Even though the molecular pathways are yet to be understood, it is also assumable that hypertension and
metabolic factors should be considered as possible mechanism involved in prostate cancer differentiation.
Conclusions: In conclusion, that the use of MRSI 3T, also without endorectal coil, before performing
prostate biopsies may represent a valid aid for the urologist in the diagnosis of PCa, allowing them to avoid
unnecessary prostate biopsies that may be negative. Furthermore, it would also be possible to reduce the
total number of biopsies, thus decreasing patient exposure to the unnecessary risks associated with biopsy.
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Can Prostate Cancer Gene 3 (PCA3) score predict results of bioptical and
pathological Gleason Score?
DECISION CURVE ANALYSIS TO EVALUATE COST/BENEFIT RATIO OF
MULTIPARAMETRIC MAGNETIC RESONANCE (MMRI) TOGETHER WITH PROSTATE
CANCER ANTIGEN 3 (PCA3) IN THE DIGNOSIS OF PROSTATE CANCER
De Luca S.1, Fiori C.1, Poggio M.1, Grande S.1, Manfredi M.1, Mele F.1, Garrou D.1, Cattaneo G.1, Aimar R.1,
Scarpa R.M.1, Passera R.3, Cappia S.2, Bollito E.2, Papotti M.2, Randone D.F.4, Porpiglia F.1
2
Department of Pathology - University of Turin, San Luigi Hospital, Orbassano Turin
Department of Nuclear Medicine3 - University of Turin, San Giovanni Battista Hospital, Turin
Department of Urology4, Gradenigo Hospital, Turin
Introduction: Aim of the study is to evaluate the correlation between PCA3 and bioptical and pathological
Gleason score in patients undergoing radical prostatectomy (RP) for prostate cancer (PCa).
Materials and Methods: 381 consecutive patients with PSA ≥ 4 ng / ml, after performing the measurement
of the PCA3 score (cut off 35) and prostate biopsy (BxP), were subjected to PR in the period between 1/2010
and the 12/2013 at 2 divisions of Urology. Exclusion criteria: taking 5-ARIs and / or previous prostate surgery.
For the determination of PCA3, samples were collected after prostate massage and analyzed to quantify
the concentrations of PSA mRNA and PCA3 mRNA using the kit PROGENSA ™. The PCA3 score was
calculated as PCA3mRNA/PSAmRNA x1000. The mapping biopsy performed under transrectal ultrasound
guidance included 12 samples in the seat device for the first biopsy and 18 samples for re-biopsy (including
the transition zone). Data were analyzed with SPSS 21.0.0 March 2013, considering significant p-values<0.05.
Results: The median age was 72 (56-75) years. The digital rectal examination (DRE) was positive in
15.4% of patients. The median PSA, free PSA / tot. and PCA3 were respectively: 10 (5.3-23) ng / ml, 15
(3-27)%, 66 (9-254). 87.4% of the patients had organ-confined disease (T1c or T2). We did not observe
any linear correlation between PCA3 and PSA tot. (p = 0.311) and between PCA3 and PSA free / tot. (p =
0.176). Relatively the BxP and RP GS we observed an “upgrading” in 37% of cases (concordance in 56.7%,
“downgrading” in 6.3%). The median PCA3 were significantly lower in patients with ≤ 33% vs.> 33% of
positive biopsies (44.2 vs. 72.7, p <0.001), in patients with indolent PCa (T1c, PSA density <0.15, biopsy
GS ≤ 6, positive samples ≤ 33%) vs. clinically significant PCa (31.2 vs. 66.3, p <0.001) and in the patients
with GS <7 vs. ≥ 7 (54 vs 68, p = 0.006 and 50 vs. 68., p = 0.007 at biopsy and RP, respectively). The high
PCA3 (≥ 100) were more related to GS only at RP (p = 0.043) but not at biopsy (p = 0.122). In multivariate
analysis the predictive factors for RP GS ≥ 7 were: positive DRE (OR = 5:47, p = 0.026), pT3 (OR = 3.68, p
=0.006) and PCA3 score (OR = 2.04, p = 0.030).
Discussion: The rate of “upgrading” was very high (37%), this may have important consequences for
treatment-decision making, in particular to select men with clinically insignificant cancer in whom active
surveillance may be proposed. In this group of patients a direct proportionality between PCA3 and GS at RP,
but not between GS at biopsy was recorded.
Conclusions:, we have documented a direct proportionality between PCA3 and GS at RP. The high rate
of “upgrading” registered requires extreme caution in selecting candidates for active surveillance with high
PCA3 score.
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G. Busetto, E. De Berardinis, A. Sciarra, V. Panebianco, R. Giovannone, G. Antonini, V. Gentile, S. Salciccia
(Roma)
Aim of the study
Several new biomarkers have been proposed to overcome the current limits of PSA. Since its introduction
in clinical practice, urinary prostate cancer gene 3 (PCA3) assay has shown promising results for prostate
cancer (PC) detection, staging and prognosis information. Furthermore multiparametric magnetic resonance
imaging (mMRI) has the ability to better describe several aspects of the natural history of PC.
To assess the role of mMRI and PCA3 tests in identifying PC patients previously negative to a prostate
biopsy, we conducted a prospective study on 171 patients with clinically suspected prostate cancer,
previously resulting negative to the TRUS-guided prostate biopsy but with persistent high PSA serum levels
(between 4 and 10 ng/ml). All patients were submitted to PCA3 test and mMRI prior to second TRUSguided prostate biopsy.
Results
Accuracy and reliability, most used diagnosis tests, have been evaluated. Four multivariate logistic
regression models have been analyzed, in terms of discrimination and cost benefit, to assess the clinical role
of PCA3 and mMRI in predicting biopsy outcome. Furthermore a decision curve analysis has been plotted.
Discussion
The repeated TRUS biopsy identified 68 (41.7%) new PC patients; 95 patients (58.3%) were not evaluated
according to the Gleason score as the biopsy was negative. The sensitivity and specificity of PCA3 test (cutoff 35) and mMRI were respectively; 68% and 49%, 74% and 90%. Decision curve analysis showed a good
performance in predictin PC cancer with the model including mMRI and PCA adjusted by age, PSA and
DRE (full model). Limitations: not randomized study, small sample size.
Conclusions
According to our experience the use of mMRI to guide prostate biopsy can increase both the accuracy of this
procedure and the sensitivity of the PCA3 test.
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HIGHLY-TRAINED DOGS’ OLFACTORY SYSTEM DETECTS PROSTATE CANCER IN URINE
SAMPLES
Multiparametric MRI (mp-MRI) in the Detection of prostate cancer index
lesions: a prospective study using whole-mount histological sections as
the reference standard.
G. Taverna, G. Taverna, L. Tidu, F. Grizzi, V. Torri, L. Castaldo, A. Mandressi, P. Sardella, G. la Torre, G.
Cocciolone, M. Seveso, G. Giusti, A. Benetti, R. Hurle, P. Graziotti (Rozzano)
Scopo del lavoro
The detection of volatile organic compounds (VOCs) in urines is a promising approach to cancer
recognition. Here, we establish the level of sensitivity and specificity at which a rigorously trained canine
olfactory system can recognize prostate cancer (PC)-specific VOCs in urine.
Materiali e metodi
A total of 902 participants were divided into two Groups: a) PC Group (n = 362) and b) Control Group (n =
540). The PC Group included patients with PC ranging from very-low risk to metastatic. The Control Group
included healthy participants, patients with non-neoplastic diseases or non-prostatic tumors. Two dogs and a
full-time, highly specialized, multidisciplinary team was involved in the study.
Risultati
The dogs achieved the following performances: Dog 1: sensitivity 100% (95%CI: 99.0-100.0%) and
specificity 98.7% (95%CI: 97.3-99.5%). Dog 2: sensitivity 98.6% (95%CI: 96.8-99.6%) and specificity
97.6% (95%CI: 95.9-98.7%). When the female participants were excluded, Dog 1 achieved a sensitivity of
100% and specificity of 98.3% (95%CI: 96.6-99.3%), while Dog 2 achieved a sensitivity of 98.6% (95%CI:
96.8-99.6%) and specificity of 96.9% (95%CI: 94.7-98.3%). When only the adult men in the Control Group
were considered, Dog 1 achieved a sensitivity of 100% and specificity of 98% (95%CI: 96-99.2%), while
Dog 2 a sensitivity of 98.6% (95%CI: 96.8-99.6%) and specificity of 96.4% (95%CI: 93.9-98.1%). Analysis
of false positive cases did not reveal any consistent pattern in terms of participant demographics or tumor
characteristics.
Discussione
Currently, patients who have had a first negative prostate biopsy are followed through consecutive PSA
examinations and several of them undergo further biopsies over time. According to Djavan et al. 22 and
Ploussard et al. 23 repeat biopsies have a detection rate respectively of 16,7%-22-%, 10.5%-16.9%,
5%-12.5% at the first, second, third repeat biopsy respectively. Prostate biopsy is an invasive procedure
associated with complications including pain, hematuria, infections, urinary retention, rectal bleeding and
more severely sepsis and death 24-27. Many patients, however, undergo an unnecessary risk simply because
they have an elevated serum PSA. The use of dogs for cancer detection emerged after the first case report in
1989 12. Over the last 24 years, preliminary studies have been published on the subject regarding different
methods and organs without any conclusive evidence.
Conclusioni
A trained canine olfactory system detects PC specific-VOCs in urine samples. These findings are
unattainable through current urological tools.
Filippo Russo, Daniele Regge, Enrico Armando, Valentina Giannini, Anna Vignati, Simone Mazzetti, Matteo
Manfredi,Fabrizio Mele, Cristian Fiori,Enrico Bollito, Loredana Correale, Francesco Porpiglia.
Division of Urology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, (TO)
Division of Pathology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, (TO)
Division of Radiology, IRCC Candiolo Hospital, Candiolo, (TO)
Introduction
Recent advances in the comprehension of PCa support the theory that disease progression and metastatization are driven by the largest tumor focus,the index lesion. According to this theory therapeutic decision-making could be heavily influenced by the clinical relevance of index lesions, which therefore need to
be accurately assessed, for example with the use of Magnetic Resonance Imaging (MRI). The MRI is currently limited to men with clinical suspicion of PCa that have already performed one or more rounds of prostate biopsies with a negative result and in staging of locally advanced disease. The aim of the study was to
prospectively evaluate endorectal mp-MRI detection rate of prostate cancer (PCa) index lesionsusing wholemount histological sections as the reference standard.
Materials and Methods:
143 patients with ultrasound biopsy confirmed PCa underwentmp-MRI with T2-weighted, diffusion-weighted (DWI) and dynamic contrast-enhanced sequences (DCE-MRI). Patients that did not undergo radical
prostatectomy, or underwent hormonotherapy, or had a negative histology at the final pathological reportwere excluded from analysis. A single expert radiologist prospectively recorded all PCa foci including the
largest (index) lesion blinded to pathologist’s biopsy report. The reference standard was 5 µm microsections
obtained from 3mm thick whole mount histological sections. All lesions were contoured by an experienced
uropathologist who assessed their volume and pathological Gleason Score (pGS).A second radiologist
matched PCa detected by pathologist with MR findings. Clinically significant PCa was defined as a tumour
with volume >0,5 cc and/or pGS >6. The main outcome measure was per-patient sensitivity. Multivariate
analysis aimed at describing the characteristics of lesions identified by MRI was performed.
Results
All 115 enrolled patients underwent radical prostatectomy. Mp-MRI correctly diagnosed 104/115 index lesions (per patient sensitivity of 90,4%), including 98/105 clinically significant index lesions (93,3%) among
which 3/3 lesions with volume <0,5 cc and pGS >6. Overall mp-MRI detected 131/206 lesions (63,6%) including 13 of 68 insignificant PCa lesions (19,1%). Two index
lesions characteristics were independently associated to detection at MRI: pGS value (ORs, 11.7; 95% CI:
2.3-59.8; P=0.003) and lesion volume (ORs, 4.24; 95% CI: 1.3-14.7; P=0.022).
Discussion
This study shows that endorectal mp-MRI has a high sensitivity in the detection ofclinically significantPCa
index lesions, while it has disappointing results in the detection of small volume low GS prostate cancer
foci.
Conclusions
The choice of the best strategy in the management of PCa is conditioned by the index lesion,that should be
carefully evaluated.
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MULTIPARAMETRIC MAGNETIC RESONANCE IMAGING SHORT-TERM FOLLOW-UP
AFTER FOCAL HEMIABLATIVE BRACHYTHERAPY FOR LOCALISED PROSTATE CANCER
PLASMA CIRCULATING MIRNAS: A NEW POTENTIAL BIOMARKER FOR PROSTATE
CANCER DIAGNOSIS
F. Mistretta, A. Losa , G. Cardone, A. Larcher, N. Fossati, G. Lista, A. Abrate, G. Gadda, G. Lughezzani, G.
Balconi, M. Lazzeri, G. Guazzoni (Milano)
S. Giglio, C. De Nunzio, R. Cirombella, F. Esperto, F. Presicce, A. Tubaro, A. Vecchione (Roma)
Aim of the study
To assess multiparametric magnetic resonance imaging (MRImp) effectiveness in the early evaluation of
post-implant dosimetry in patients treated with hemiablative focal brachytherapy (FB) for localised prostate
cancer (PCa).
The study is a prospective observational assessment of 7 patients with unilateral low-grade localized PCa
who underwent FB at a tertiary high volume hospital. To evaluate morphology of the gland, seeds position
and post implant dosimetry, 30 days after the treatment a morphological 1.5T MR study was performed.
The post-plan dosimetries were based on unenhanced T1w and T2w imaging, obtained using a phased-array
body coil and a dedicated treatment planning system (Variseed 7.0, Varian) with an image fusion software.
MRImp follow-up was scheduled at 6, 12 and 24 months after FB, with an endorectal coil 1.5T MR
system, to evaluate morphology, vascularization and metabolism of the gland. All the patients underwent
MR conventional multiplanar Turbo Spin-Echo (TSE) T2w sequences, followed by dynamic axial contrast
enhanced (ce) Gradient-Echo (GRE) T1w and spectroscopic acquisitions.
Results
At 30 days after FB, prostate resulted more than 5 mm larger than the original gland on morphologic
T1w and T2w MRI. A 40% mean decrease in size of the gland was showed by MRI at 24 months after
the treatment. In the lesion area, 30 days after FB procedure, T2w images showed a heterogeneously
iso-hyperintense parenchima, without a significative different signal intensity between peripheral and
central gland. Radioactive seeds were seen on GRE T1w image as small focal signal intensity voids.
MRImp imaging follow-up performed 6, 12 and 24 months after FB showed reduction in size of treated
areas, with diffuse reduction in signal intensity on T2w images and reduction in contrast enhancement
on dynamic ce GRE T1w images, due to parenchimal fibrosis and atrophy. All the patients showed
persistence of isointensity of the spared prostatic tissue. Dynamic ce MR evaluation showed a reduction
of the vascularization of the treated areas. MR spectroscopy showed metabolic alterations, with significant
decrease of metabolites, in particular of choline, in the treated areas. Re-biopsy after 12 months showed
absence of cancer in treated areas.
Discussion
The increased rate of detection of indolent and non-significant cancer led to a change in PCa epidemiology
forcing physicians to a re-examination of the standard radical therapies and to consider a more important
role for focal therapies. Recent progress in MRI of the prostate could further improve the role of imaging for
predicting the clinical significance of cancer and give a real-time feedback after most focal therapies.
Aim of the study
Recent studies have demonstrated that aberrant expressions of miRNAs are closely associated with the
development, invasion, metastasis and prognosis of various cancers including prostate cancer. Circulating
miRNAs may be useful for early diagnosis as well as to predict the clinical outcome and the treatment
response. The aim of this study was to investigate the hypothesis that changes in circulating miRNAs
represent potentially useful biomarkers for the diagnosis of prostate cancer.
From 2013 onwards, a consecutive men undergoing 12-core prostate biopsy at one center in Italy were
enrolled into a prospective database. Indications for a prostatic biopsy were a PSA value ≥ 4 ng/ml and/
or a positive digital rectal examination (DRE). 7,5 ml EDTA blood sample were drawn before the biopsy,
the samples were centrifuged at 1800 RPM for 20 min and the plasma stored at -20°C. Total RNAs has
been extracted using Plasma/serum Circulating and Exosomal RNA purification mini kit (NorgenBiotek)
and assessed on RNA 6000 Nano Chip using an Agilent 2100 bioanalyzer (Agilent Technologies). Next
generation sequencing (NGS) have been carried out at the Department of Molecular Virology, Immunology
and Medical Genetics and Comprehensive Cancer Center, Ohio State University, OH, USA using
SOLiD5500XL (Applied Biosystems). Receiver-operator characteristics (ROC) curve analysis was used to
evaluate the diagnostic accuracy of miRNAs for the final histopathological diagnosis of prostate cancer.
Results
32 patients were enrolled with a mean age and PSA of 66.6 years (SD ±7.9) and 14.3 (range to 0,53-185)
ng/ml, respectively. 16 patients (50%) had cancer on biopsy; 8 with Gleason score 6; 3 with a Gleason
score 7 and 5 with a Gleason score ≥8. Profiling of microRNAs by deep sequencing allowed to identify
a “signature” of 27microRNAs aberrant expressed in prostate cancer samples. 24miRNAs were overexpressed and 3 were down-regulated in patients with prostate cancer when compared to patients with a
negative biopsy. Specifically, ROC curve analysis also showed as a small subgroup consisting of 6 miRNAs
(miR-125b, miR-532-5p, miR-874, miR-3940, miR-188-5p, miR-15a*) presented a good performance to
discriminate patients with prostate cancer (AUC = 0.805; 95%CI; 0.77-0.85).
Discussion
NGS seems to be a valid method to evaluate miRNAoma. In our experience mRNA presented a good
accuracy for the detection of PCa.
Conclusions
Our preliminary results, although should be validated in a large group of patients that is ongoing in our
centre, confirmed the possible role of miRNA as novel biomarker for the diagnose of patients with prostate
cancer.
Conclusions
MRImp can be an effective imaging technique in the follow-up of prostate tumors treated with FB, in
particular in the evaluation of postimplant dosimetry. MR imaging might also play a role in the evaluation of
patients with clinical or laboratory suspect of recurrence.
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PSA KINETICS PARAMETERS ARE PREDICTIVE OF PET FEATURES WORSENING IN
PATIENTS WITH BIOCHEMICAL RELAPSE AFTER PROSTATE CANCER TREATMENT
WITH RADICAL INTENT: RESULTS FROM A LONGITUDINAL COHORT STUDY
SATURATION BIOPSY CON SINGOLO ACCESSO TRANS-PERINEALE E SCHEMA A 32
PRELIEVI: DESCRIZIONE DELLA TECNICA E ANALISI DEGLI OUTCOME IN 152 PAZIENTI.
G. Siena, M. Gacci, T. Cai, A. Minervini, A. Tuccio, A. Cocci, O. Saleh, A. Raugei, A. Pupi, S. Serni, M.
Carini (Firenze)
Aim of the study
To identify prostate-specific antigen (PSA) kinetics parameters predictive of (18)F-fluorocholine PET (18FC
PET/CT) features worsening in a cohort of patients with biochemical failure after prostate cancer treatment
This longitudinal cohort study comprised 103 consecutive patients. All patients underwent two 18FC PET/
CT: one at baseline (PET 1) and one after 6 months (PET 2). Total PSA (tPSA), PSA velocity (vPSA), PSA
doubling time (dtPSA), absolute variation of PSA values between PET2 and PET1 (∆PSA), percentage
variation of PSA between the two PSA measurements were measured from each patients (PSA%).
Progression of disease on 18FC PET/CT findings were compared with the PSA kinetics parameters. The
major outcome measures were the disease progression at the PET
Results
18FC PET/CT progression between PET1 and PET2 was reported in 64 patients (62.1%), while in 39 cases
remained unvaried. We found that the following PSA kinetic parameters are correlated with worsened
18FC PET/CT findings: ∆PSA >5 ng/mL (OR=6.44;[95%CI 1.04-39.6]; p=0.04), vPSA >6 ng/mL/month
(OR=5.2;[95%CI 0.9-29.8]; p=0.05) and PSAdt
Discussion
the knowledge of the PSA level may not be sufficient to decide whether referral to 18F-CH-PET is
appropriate or not and 18F-CH-PET features predictive of disease progression are still matter of discussion.
Conclusions
PSA kinetics is strictly related to 18FC PET/CT findings. In patients with biochemical relapse, a ∆PSA >5
ng/mL, a PSAdt 6 ng/mL/month are highly predictive of 18FC PET/CT feature worsening, independently
from the treatment received.
S. Micali, E. Martorana, A. Ghaith, R. Galli, M. Paterlini, G. Bianchi (Modena)
Scopo del lavoro
Descrivere la nostra tecnica di saturation biopsy, analizzare I risultati e compararli con quelli delle alter
tecniche di saturazione riportate in letteratura
Materiali e metodi
Tra Ottobre 2008 e Luglio 2013, 152 pazienti consecutive sono stati sottoposti a saturation biopsy
transperineale. 27 pazienti sono stati esclusi per la mancanza di dati completi. L’età media dei pazienti era
di 64,74 anni, il valore medio del PSA totale era di 9,49 ng/ml, il valore medio del PSA density era di 0,184,
e i volume prostatico medio era di 57,95 ml. Tutti i pazienti erano stati sottoposti ad almeno 1 precedente
mapping prostatico con diagnosi di proliferazione microacinare atipica nel 24,8% dei casi, neoplasia
intraepiteliale di alto grado nel 39,2% dei casi e infiammazione o IPB nel 36% dei casi Abbiamo eseguito
una saturation biopsy trans-perineale con schema a 32 prelievi senza template. L’accesso alla ghiandola è
stato realizzato, previa anestesia locale con 10 ml di carbocaina al 2%, attraverso una sola puntura sulla linea
perineale media a 1.5 cm dallo sfintere anale.
Risultati
La detection rate di cancro alla prostate è stata del 38.4%. La diagnosi di cancro alla prostate si è avuta
nel 61.3% dei pazienti con diagnosi di ASAP in almeno 1 dei precedenti mapping prostatici (p < 0.007)
mentre restava bassa e senza differenze significative tra i pazienti con pregressa diagnosi di HGPIN e
IPB. La detection rate si riduceva con l’incrementare del numero dei precedenti mapping prostatici e con
l’incrementare del volume prostatico (p < 0.001), e incrementava con l’aumentare del PSA density (p =
0.03). Il 20.8% dei pazienti ha avuto diagnosi solo su prelievi eseguiti sulla zona anteriore più la zona di
transizione. Non sono state osservate complicanze maggiori e solo 2 pazienti hanno riportato un episodio di
ritenzione urinaria acuta risolta con il posizionamento di un catetere vescicale.
Discussione
La nostra tecnica presenta tutti i vantaggi dell’approccio trans-perineale (miglior campionamento della
zona anteriore e di transizione, minor rischio di lesioni del plesso del santorini, minor rischio di infezioni e
urosepsi) eseguito con un accesso singolo e quindi mini-invasivo (minor sanguinamento, ematomi, lesioni a
carico d retto, uretra, corpo spongioso, fasci vascolo-nervosi). Questi vantaggi sono associati ad una elevata
detection rate se comparata con quella di altre tecniche descritte in letteratura.
Conclusioni
La tecnica standard di saturation biopsy, il numero più accurato di prelievi e il timing di biopsia sono
ancora materia di dibattito. La nostra saturation biopsy è la prima tecnica trans-perineale con uno schema
a 32 prelievi eseguiti attraverso un singolo accesso. Questa tecnica si è dimostrata sicura e accurata per la
diagnosi di cancro alla prostata in pazienti ad alto rischio di PCa e precedenti mapping prostatici negativi.
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P 218
SIDE-EFFECTS AND COMPLICATIONS OF TRANSPERINEAL PROSTATE (TP) BIOPSIES
- THE FIRST PROSPECTIVE EVALUATION USING A PATIENT REPORTED OUTCOME
MEASURES (PROM) TOOL
THE INFLUENCE OF PHYSICAL ACTIVITY ON PROSTATE CANCER DIAGNOSIS: A BIOPSY
COHORT ANALYSIS
G. Gaziev, G. Patruno, L. Carmona-Echeverria, E. Serrao, K. Wadhwa, J. Frey, R. Miano, G. Vespasiani, T.
Kuru, B. Hadaschik, G. Muir, C. Kastner (Roma)
Aim of the study
Transrectal ultrasound guided biopsies of the prostate (TRUSP) are standard for detection of prostate cancer
(CaP). Increasing sepsis rates have turned many urologists to using the TP approach with alleged higher
detection rates and negligible infection rates. There is no published PROM (Patient Reported Outcome
Measure) data to assess side-effects and complications of TP biopsies. We aimed to prospectively assess
their occurrence using a validated PROM tool.
Using the PROBE (Prospective randomized open blinded end-point) PROM tool, validated for TRUSP
biopsies as part of the ProtecT (Prostate Testing for Cancer and Treatment) study, we collected data
prospectively in four centres between February and November 2013. All patients undergoing TRUSP or TP
biopsies were asked to complete the questionnaires immediately after the procedure and at follow up.
Results
655 patients were included in the study, of these 65% (429) of patients in total completed both
questionnaires (228 for TRUS and 201 for TP biopsy). The side effect profile and demographics can be seen
on table 1. There was one confirmed case of sepsis in the TRUS group, and 4 patients had clot retention in
the TP group (1.99%). More than twice the numbers of cores were taken for TP biopsies (12.17 VS 27.1),
yet, subjective infection and urinary retention rates were measured significantly less in the TP group.
Discussion
.
Conclusions
This study reports the first prospective PROM based assessment of side-effects and complications from TP
biopsies. Despite accruing more biopsies TP appears to have a similar side effect profile to TRUS with fewer
septic events and – surprisingly – lower urinary retention rate.
A. Tubaro, F. Presicce, L. Cindolo, M. Gacci, C. Leonardo, F. Cancrini, M. Bonetto Gambrosier, M. Carini,
M. Lanciotti, F. Pellegrini, L. Schips, A. Tubaro (Roma)
Aim of the study
A possible relationship between prostate cancer and physical activity has been proposed. The Physical
activity scale for elderly (PASE) questionnaire has been recently proposed to evaluate the association
between physical activity and benign prostatic hyperplasia. Aim of our study was to evaluate the association
between physical activity and prostate cancer (PCa) risk and grade in a consecutive series of men
undergoing prostate biopsy.
From 2011 onwards, a consecutive men undergoing 12-core prostate biopsy were enrolled into a prospective
database. Indications for a prostatic biopsy were a PSA value ≥ 4 ng/ml and/or a positive digital rectal
examination (DRE). Body mass index (BMI) and waist circumferences were measured before the biopsy.
Blood samples were collected before biopsy and tested for: total PSA, glycemia, HDL, trygliceridemia
levels. Blood pressure was recorded. Metabolic syndrome (MetS) was defined according to the Adult
Treatment panel III. PASE questionnaire was colelcted before the biopsy.
Results
286 patients were enrolled with a median age and PSA of 68 (IQR 62/74) years and 6.1 ng/ml (IQR 5/8.8)
respectively. Median BMI was 26.4 kg/m2 (IQR: 24.6/29); median waist circumference was 102 cm (IQR:
97/108) and 75 pts (26%) presented a Metabolic syndrome. One-hundred and six patients (37%) had
prostate cancer on biopsy. Patients with PCa presented an higher PSA (6.7 ng/ml, IQR: 5/10 vs 5.6 ng/ml,
IQR: 4.8/8; p= 0.007) and a lower PASE score (108, IQR: 66/150 vs 126, IQR 84/198; p=0.005). PASE
score inversely correlate with waist circumference (σ: -0.196; p= 0.004) and Age (σ-0.223; p= 0.0041). On
multivariate analysis PASE (OR: 0.996 per unit, 95%CI: 0.993-1.000; p= 0.003) and PSA (1.054 per unit
95%CI: 1.013-1.116, p= 0.04) were the only independent risk factor for prostate cancer diagnosis.
Discussion
In our single center study, a reduced physical activity evaluated by the PASE questionnaire is associated
with an increased risk of prostate cancer on biopsy, although these results should be confirmed in a larger
multicenter study.
Conclusions
Even though the molecular pathways are yet to be understood, it is assumable that a reduced physical
activity and the associated metabolic abnormalities should be considered as possible factors involved in
prostate cancer pathogenesis.
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P 220
TRUE FALSE NEGATIVE MRI SCANS IN PROSTATE CANCER SCREENING: EXPERIENCE
FROM A TERTIARY CANCER CENTRE.
ANALISI MULTIVARIABILE IN 553 PAZIENTI SOTTOPOSTI A PRELIEVO DI MUCOSA
ORALE PER URETROPLASTICA: VALUTAZIONE DELLE COMPLICANZE PRECOCI,
TARDIVE E DEL GRADO DI SODDISFAZIONE
G. Gaziev, G. Patruno, E. Serrao, K. Wadhwa, L. Carmona-Echeverria, G. Vespasiani, T. Barrett, V.
Gnanapragasam, A. Doble, R. Miano, B. Koo, C. Kastner (Roma)
Aim of the study
With the advent of MRI guided biopsy, one important question is that of false negative scans: that is
when the MRI has reported no lesion but the patient subsequently is found to have a tumour either on
prostatectomy or by subsequent biopsy. This study aims to determine the rate and causes of false negative
prostate MRI exams and suggest methods to improve current practice.
148 prostate MRI exams (T2WI, DWI and ADC maps) conducted in patients with suspected prostatic
cancer, prior to transrectal ultrasound (TRUS)-guided biopsy were retrospectively reviewed and compared
with histological Gleason grade (June 2011 to May 2013). False negative lesions on imaging were identified
and retrospectively reviewed by a single experienced radiologist. The prostatic sectors where the histologic
lesions were found were characterized.
Results
False negative lesions were identified in 28 exams out of 148 (18.92%; 46 lesions). This number was
reduced by the second reader to 25 exams (35 lesions). Most false negative lesions were located in sector 1
(10/46) and 6 (11/46) followed by sectors 3L, 4L and 5L (6/46 each); Table 1.
Discussion
Double reading decreased the number of false negative scans by 23.91% showing the potential value of
doing this. Furthermore, we observed that many of the false negative lesions (15/46) were MRI-invisible
, even after double-reading. This might be due to the limitations of the technique; the volume of diseased
tissue required in each voxel for the lesion to be detected and the subtle nature of many areas of abnormality.
In addition, anterior lesions were more likely to be missed than lesions elsewhere within the prostate, as has
previously been shown.
Conclusions
Although MRI of the prostate still cannot substitute biopsy; double reading is a potentially valuable tool to
decrease the number of false negatives.
G. Romano, M. Castigli, M. Maleci, M. Pulvirenti, S. Sansalone, M. de Angelis (Arezzo)
Scopo del lavoro
La morbidità associata al prelievo di graft di mucosa orale (GMO) è tuttora un problema aperto. Noi
abbiamo studiato le complicanze precoci, tardive ed il grado di soddisfazione finale in pazienti sottoposti a
prelievo di GMO attraverso un’analisi multivariabile.
Materiali e metodi
553 pazienti di età media di 40,7 anni (range 14-79 anni) sono stati sottoposti a prelievo di GMO da unica
guancia o due guancie utilizzando una tecnica standard: la lunghezza media del graft è risultata di 4 cm, la
larghezza media di 2.5 cm; il graft presentava sempre una forma ovoidale/ellisoidale, ed il sito di prelievo è
sempre stato chiuso con suture a punti staccati o continue. L’incidenza delle complicanze precoci, tardive ed
il grado di soddisfazione post-chirurgica dei pazienti è stato studiato utilizzando dei questionari non validati
somministrati 10 giorni dopo l’intervento per valutare le complicanze precoci e 4 mesi dopo, in occasione
delle visite di follow-up, per valutare le complicanze tardive. Il questionario comprendeva 6 domande per
investigare le complicanze precoci, 14 domande per investigare le complicanze tardive e la soddisfazione
finale del paziente. Le complicanze soggettive sono state misurate utilizzando un punteggio da 0 a 3 dove
0 indicava l’assenza di complicazioni, 1 indicava un basso punteggio, 2 un punteggio medio e 3 un alto
punteggio (forte dolore o intorpidimento).
Risultati
Un’analisi univariata e multivariata sono state effettuate per predirre l’insoddisfazione precoce e tardiva
dei pazienti. Il sanguinamento è stata documentato nel 3,4% dei pazienti. Complessivamente il 53,2% dei
pazienti non ha accusato alcun dolore e il 36,3% ha segnalato nessun gonfiore. L’analisi delle complicazioni
tardive ha mostrato che il 95,5% dei pazienti ha dichiarato che la chiusura chirurgica della ferita non
ha causato alcuna difficoltà ad aprire la bocca o problemi a sorridere (98,2%) e /o secchezza delle fauci
(95,8%). Complessivamente il 98,2% dei pazienti sono rimasti soddisfatti per la procedura. L’analisi
univariata e multivariata ha rivelato che il prelievo per innesto bilaterale era l’unico elemento significativo di
insoddisfazione del paziente (OR 2.85, p = 0.01 e OR 2.72, p = 0.02, rispettivamente).
Discussione
Nella nostra esperienza su 553 pazienti il GMO prelevato da unica guancia con sutura dell’area di prelievo
è una procedura che presenta un’incredibile grado di soddisfazione da parte dei pazienti. Le complicanze
precoci e tardive non progrediscono verso postumi permanenti.
Conclusioni
Il GMO ovoidale da una singola guancia con chiusura della ferita è una procedura sicura con alta
soddisfazione del paziente. L’unico elemento predittivo e significativo di insoddisfazione del paziente è il
GMO bilaterale
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ARGUS-T DEVICE NELL’INCONTINENZA URINARIA MASCHILE: RISULTATI NEL BREVE
PERIODO IN 182 PAZIENTI
CONFEZIONAMENTO INTRACORPOREO DI SLING RETROPUBICO SOTTO-URETRALE
AUTOLOGO DURANTE PROSTATECTOMIA RADICALE ROBOTICA PER IL RECUPERO
PRECOCE DELLA CONTINENZA URINARIA: RISULTATI PRELIMINARI.
F. Visalli, S. Siracusano, C. Tallarigo, M. Favro, S. Ciciliato, L. Toffoli, T. Silvestri, M. Saccomanni, R.
Talamini, A. Kugler (Trieste)
Scopo del lavoro
E’ noto che il 5-48% dei pazienti sottoposti a prostatectomia radicale è affetto da insufficienza sfinterica
con incontinenza urinaria da sforzo (IUS). Lo sfintere urinario artificiale è considerato il trattamento gold
standard per questo tipo di patologia. Recentemente è stato dimostrato che nei pazienti con IUS di piccola e
media entità lo sling sottouretrale consente un recupero della continenza urinaria. Lo scopo di questo studio
è di valutare i risultati a breve termine dei pazienti trattati con dispositivo ARGUS-T
Materiali e metodi
Dal Giugno 2008 al Marzo 2013, 161 pazienti affetti da IUS post-prostatectomia radicale e 21 pazienti
affetti da IUS post-TURP sono stati sottoposti a posizionamento del dispositivo ARGUS-T. La popolazione
in studio è stata suddivisa in base al grado di incontinenza: lieve (1-2 pad/die), moderata (3-5 pad/die)
e grave (>5 pad/die). E’ stato considerato come risultato soddisfacente il miglioramento o la risoluzione
dell’incontinenza urinaria rispetto alla condizione di partenza. 21/182 pazienti (11.5%) erano affetti da IUS
lieve, 96/182 pazienti (52.7%) erano affetti da IUS moderata e 65/182 pazienti (35.7%) erano affetti da IUS
grave. 49/182 pazienti (26.9%) erano stati precedentemente sottoposti a radioterapia adiuvante. Per ogni
paziente è stata valutata la qualità di vita mediante l’impiego di questionari specifici (VAS score scale/ QoL
score scale) ed è stato quantificato il numero di pad impiegati giornalmente prima e dopo il posizionamento
del dispositivo ARGUS-T.
Risultati
L’età media dei pazienti era di 71 anni (range 50-86 anni) mentre il follow-up medio è stato di 22 mesi (1-59
mesi). Nel nostro studio i risultati sono apparsi soddisfacenti in 157/182 pazienti (86.2%) e in 37/49 pazienti
(75.5%) che erano stati sottoposti a pregressa radioterapia adiuvante. L’analisi statistica infine ha dimostrato
una significativa differenza per quanto riguarda il numero dei pad impiegati giornalmente prima e dopo la
procedura di posizionamento dello sling (p
Discussione
Al momento questo studio è il primo a presentare i risultati a breve termine per quanto riguarda il dispositivo
ARGUS-T. Questa soluzione chirurgica sembra essere sicura ed il suo utilizzo indicato soprattutto nei
pazienti radiotrattati.
Conclusioni
Studi ulteriori con follow-up nel medio e lungo termine sono necessari per confermare i risultati ottenuti nel
breve periodo.
A. Cestari, M. Ferrari, M. Zanoni, F. Fabbri, M. Sangalli, M. Ghezzi, F. Sozzi, P. Rigatti (Milano)
Scopo del lavoro
Descriviamo il primo sling retropubico sotto-uretrale autologo creato e posizionato in corso di
prostatectomia radicale robotica (RARP). Sono presentati la tecnica chirurgica ed i dati preliminari
riguardanti la sua efficacia nel determinare un recupero post-operatorio precoce della continenza urinaria.
Materiali e metodi
Tra novembre 2013 e febbraio 2014 una coorte di 60 pazienti, continenti e neurologicamente sani, affetti
da carcinoma della prostata localizzato e candidati a RARP presso un singolo Centro ad alto volume sono
stati prospetticamente randomizzati rispetto al confezionamento dello sling. La tecnica prevede i seguenti
punti-chiave: 1) all’inizio della linfoadenectomia pelvica destra, attraverso un’incisione peritoneale lungo il
legamento ombelicale laterale, isolamento e rimozione del dotto deferente; 2) modellamento extracorporeo
del campione rimosso in un tratto di dotto deferente di 5 cm inserito assialmente al centro di un doppio filo
non assorbibile di 14 cm; 3) posizionamento dello sling autologo ottenuto immediatamente sotto il piano
ricostruito del muscolo retto-uretrale e suo ancoraggio al periostio della branca pubica bilateralmente; 4) al
completamento dell’anastomosi vescico-uretrale, fissaggio definitivo dello sling con trazione dei capi per
ottenere il sostegno uretrale desiderato. Il recupero della continenza urinaria è stato valutato a 5 (rimozione
del catetere vescicale), 10 e 30 giorni dall’intervento attraverso la registrazione del numero di pads
utilizzati giornalmente e dello score dell’International Consultation on Incontinence Questionnaire-Urinary
Incontinence-Short Form (ICIQ-UI-SF). I test statistici Chi-square ed Indipendent Sample T-test sono stati
utilizzati per indagare il recupero della continenza urinaria tra i due gruppi.
Risultati
Dai clinici completi sono stati raccolti in 60/60 (100%) pazienti. La media±DS dell’età è stata 63±9.0 anni.
A 5, 10 e 30 giorni di follow-up la media±DS del numero di pads giornalmente utilizzati è stata nei gruppi
non-sling e sling rispettivamente di 1.9±1.2 vs 1.7±1.4 (p=0.5), 1.8±1.3 vs 1.3±1.3 (p=0.1) e 1.1±1.2 vs
0.4±0.8 (p=0.01); ad 1 mese la media±DS dello score ICIQ-UI-SF 4.8±4.6 vs 1.8±3.4 (p=0.01). A 30 giorni
i pazienti portatori di sling sono risultati essere associati al non utilizzo di pads (Χ2: 4.7; p=0.03) rispetto al
gruppo non-sling.
Discussione
Il confezionamento dello sling retropubico sotto-uretrale autologo da noi ideato permette di raggiungere a 30
giorni dall’intervento un recupero della continenza urinaria significativamente migliore rispetto ai pazienti
non sottoposti a tale tecnica.
Conclusioni
Sebbene questi dati preliminari necessitino di essere confermati in campioni più estesi, la nostra
iniziale esperienza mostra che lo sling retropubico sotto-uretrale autologo è tecnicamente fattibile e può
rappresentare un valido strumento per migliorare il tasso di recupero precoce della continenza urinaria nei
pazienti sottoposti a RARP.
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NUOVA SLING TRANSOTTURATORIA INSIDE-OUT PER IL TRATTAMENTO
DELL’INCONTINENZA DA SFORZO POST-CHIRURGICA MASCHILE: RISULTATI
PRELIMINARI A MEDIO-TERMINE
URETROPLASTICA BULBARE CON DOPPIO INNESTO DORSALE PIU’ VENTRALE DI
MUCOSA BUCCALE: RISULTATI A LUNGO TERMINE.
E. Sacco, R. Bientinesi, S. Recupero, F. Marangi, N. Foschi, M. Racioppi, F. Pinto, A. Totaro, P. Bassi
(Roma)
Scopo del lavoro
Riportare i risultati preliminari in termini di efficacia e sicurezza di una nuova sling per l’incontinenza da
sforzo post-chirurgica maschile.
Materiali e metodi
Studio prospettico monocentrico. Dal 11/2012 al 11/2013, 18 pazienti affetti da incontinenza urinaria
da sforzo dopo prostatectomia radicale (16) o dopo TURP (2) sono stati sottoposti a impianto di sling
transotturatoria con tecnica inside-out sec. DeLeval. La sling utilizzata è la TiLoop® (pfmmedical, Köln,
Germany), una mesh in polipropilene rivestita di titanio per migliorarne la biocompatibilità, 40x1,5
cm. I pazienti sono stati valutati preoperatoriamente e a 3-6-12 mesi postoperatori con uroflussometria,
numero di pannolini/die, studio urodinamico (preoperatorio), International Consultation on Incontinence
Questionnaire–Short Form (ICIQ-SF) e Patient Global Impression of Improvement (PGI-I; score 1-7),
grado di soddisfazione(si/no). La guarigione è stata definita come non utilizzo di pannolini o impiego di un
assorbente di sicurezza, mentre una riduzione di almeno il 50% del numero di pannolini è stata considerata
come miglioramento.
Risultati
Sedici pazienti (89%) sono stati valutati escludendo due (pregressa prostatectomia radicale) persi al
follow-up. Preoperatoriamente, 6 (37,5%) e 10 (62,5%) pazienti usavano due o da tre a cinque pannolini,
rispettivamente. Due pazienti erano precedentemente radiotrattati. Dopo un follow-up mediano di 12 mesi
(5-17 mesi), 8 (50%) pazienti risultano guariti, 4 (25%) risultano migliorati e 4 (25%) non hanno riportato
beneficio (pazienti con uso di 4-5 pads/die, due radiotrattati). Lo score medio del ICIQ-SF si è migliorato da
17,7 nel preoperatorio a 7,4 nel postoperatorio (p
Discussione
I risultati preliminari della sling transotturatoria TiLoop® sono soddisfacenti e sovrapponibili a
quelli riportati in letteratura per sling simili di tipo fisso, in una casistica con incontinenza di grado
prevalentemente moderato-severo. Gli insuccessi hanno riguardato pazienti con incontinenza severa o
radiotrattati, pertanto una migliore selezione dei pazienti potrebbe ulteriormente migliorare i risultati.
Conclusioni
La sling transotturatoria TiLoop® risulta efficace soprattutto in pazienti con incontinenza lieve-moderata
e la tecnica inside-out impiegata risulta sicura. Studi prospettici su casistiche di maggiore numerosità sono
necessari per confermare questi risultati.
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E. Palminteri, E. Berdondini, G. Antonini, G. Di Pierro (Arezzo)
Scopo del lavoro
Riportiamo i risultati a lungo termine sulla riparazione di stenosi bulbari strette trattate con la nuova tecnica
di ampliamento con doppio innesto dorsale-ventrale di mucosa buccale (MB).
Materiali e metodi
Tra il 2002 ed il 2013, abbiamo sottoposto ad uretroplastica con doppio innesto dorsale-ventrale di MB,
166 pz (età media 40 aa) con stenosi dell’uretra bulbare stretta. L’eziologia della stenosi era sconosciuta
in 118 pz (71%), da catetere in 32 (19,4%), traumatica in 7 (4,2%), infettiva in 2 (1,2%), iatrogenica in
7 (4,2%). Dei 166 pz, 39 (23,4%) non avevano subito precedenti trattamenti mentre 3 (2%) erano stati
precedentemente sottoposti a dilatazioni, 64 (39%) ad uretrotomia interna, 2 (1%) ad uretroplastica, 58
(35%) a trattamenti mutipli. Dopo essere stata aperta ventralmente, l’uretra stenotica è stata ampliata
dorsalmente sec. Asopa con il primo innesto di MB; successivamente il canale è stato allargato ventralmente
con il secondo innesto di MB. In 6 pz è stato effettuato un prelievo bilaterale di MB dalle guance, mentre
in tutti gli altri un prelievo unico suddiviso poi in due parti. Il prelievo è stato di lunghezza media 5,7 cm
(range 4-8) e larghezza media 1,8 cm (range 1-2,5). La lunghezza media dell’innesto dorsale è stata 2,25
(range 1-10), quella dell’innesto ventrale 4,12 (range 2-11). I risultati clinici sono stati considerati fallimento
in caso di getto urinario ostruito oppure di necessità di qualsiasi ulteriore manovra postoperatoria, inclusa la
dilatazione.
Risultati
Alla rimozione del catetere dopo 3 settimane in 9 (5%) casi la cistouretrografia minzionale ha evidenziato
una fistola, guarita con una prolungata cateterizzazione. Con un follow up medio di 65 mesi (range 12-144)
abbiamo avuto 149 (90%) successi. Dei 17 (10%) insuccessi, 10 sono stati sottoposti ad uretrotomia, 4 a reuretroplastica con MB e prepuzio, 3 a perineostomia.
Discussione
La riparazione delle stenosi bulbari tramite sezione ed anastomosi termino-terminale può causare
complicanze sessuali, mentre l’ampliamento con singolo innesto di MB può risultare insufficiente ad
allargare adeguatamente l’uretra ristretta. Nel 2008 nelle stenosi bulbari strette abbiamo proposto la tecnica
dell’ampliamento con doppio innesto dorsale-ventrale di MB allo scopo di evitare la sezione e asportazione
dell’uretra ristretta ed al contempo ridurre il rischio di recidiva dovuto ad ampliamento uretrale insufficiente
con un singolo innesto. Il nostro studio con casistica ampia e lungo follow-up ha dimostrato un elevato
successo della tecnica del doppio innesto dorsale-ventrale di MB.
Conclusioni
La nuova chirurgia uretrale è caratterizzata dal risparmio dei tessuti uretrali tramite ampliamento dorsale
o ventrale del piatto uretrale stenotico preservato e non sezionato. Con un follow-up lungo, il doppio
ampliamento uretrale con innesto dorsale-ventrale di MB ha dimostrato un’alta percentuale di successo nella
riparazione delle stenosi bulbari strette.
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URETROPLASTICA DI AMPLIAMENTO DORSO-LATERALE CON INNESTI SECONDO
KULKARNY: RISULTATI A MEDIO TERMINE.
VALUTAZIONI A LUNGO TERMINE DELLE COMPLICANZE POST IMPIANTO DI PROACT®.
E. Palminteri, E. Berdondini, G. Cucchiarale, G. Milan, U. Ferrando (Arezzo)
Scopo del lavoro
Riportiamo i risultati a medio termine sulla riparazione di stenosi uretrali anteriori trattate con la nuova
tecnica di ampliamento dorso-laterale con innesti secondo Kulkarny.
Materiali e metodi
Tra il 2009 ed il 2013, abbiamo sottoposto ad uretroplastica di ampliamento con innesto dorso-laterali sec.
Kulkarny, 69 pz (età media 50 aa) con stenosi dell’uretra anteriore: 11 pz con stenosi bulbare, 34 con stenosi
peniena, 24 con stenosi peno-bulbare. L’eziologia della stenosi era sconosciuta in 22 pz (31.8%), da catetere
in 19 (27.5%), traumatica in 2 (2.9%), lichen sclerosus in 8 (11.6%), iatrogenica in 13 (18.9%), ipospadia
fallita in 5 (7.3%). Dei 69 pz, 12 (17.4%) non avevano subito precedenti trattamenti mentre 5 (7.3%) erano
stati precedentemente sottoposti a dilatazioni, 9 (13%) ad uretrotomia interna, 5 (7.3%) ad uretroplastica,
38 (55%) a trattamenti mutipli. La lunghezza media della stenosi era 5 cm (range 1-17). Dopo essere stata
staccata dorso-lateralemente dai corpi cavernosi da un solo lato, l’uretra è stata ampliata con innesti di
mucosa buccale (MB) e/o cute peniena (CP) adagiati sui corpi cavernosi e preservando il supporto uretrale
vascolare controlaterale. Gli innesti usati sono stati MB in 29 (42%) pz, CP in 38 (55%) pz, MB + CP in 2
(3%) pz. La MB è stata prelevata da una singola guancia in 25 (86%) casi, da entrambe le guance in 4 (14%)
casi. La lunghezza media dell’innesto è stata 6.1 cm (range 2.5-17). I risultati clinici sono stati considerati
fallimento in caso di getto urinario ostruito oppure di necessità di qualsiasi ulteriore manovra postoperatoria,
inclusa la dilatazione.
Risultati
Alla rimozione del catetere dopo 4 settimane in 7 (10%) casi la cistouretrografia minzionale ha evidenziato
una fistola, guarita con una prolungata cateterizzazione. Con un follow-up medio di 30 mesi (range 1251) abbiamo avuto 61 (88%) successi. Degli 8 (12%) insuccessi, 5 sono stati sottoposti ad uretrostomia
derivativa, 3 sono in attesa di soluzione.
Discussione
Nel 2009 Kulkarny ha proposto per il trattamento delle stenosi uretrali anteriori, soprattutto quelle lunghe,
l’ampliamento uretrale con innesti appoggiati ai corpi cavernosi. La mobilizzazione dorso-laterale su un
solo lato dell’uretra, lasciando intatta la vascolarizzazione uretrale controlaterale, rappresenta un ulteriore
riduzione dell’aggressività chirurgica rispetto alla tradizionale tecnica di scollamento dorsale totale dai
corpi cavernosi. Il nostro studio con casistica ampia e follow-up medio dimostra che la tecnica ha un elevato
successo ed una percentuale non alta di complicanze.
Conclusioni
La riparazione delle stenosi uretrali anteriori tramite ampliamento dorso-laterale con innesti secondo
Kulkarny ha dimostrato nel follow-up a medio termine un’alta percentuale di successo.
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M. Abbinante, M. Rossanese, B. Grossetti, G. De Giorgi, L. Paganin, S. Praturlon, V. Ficarra (Udine)
Scopo del lavoro
Valutazioni a lungo termine delle complicanze post impianto di ProACT®.
Materiali e metodi
Dal Novembre 2005 al Giugno 2013 sono stati eseguiti presso il nostro centro 252 impianti di protesi
ProACT® in 179 pazienti. 157 impianti erano stati posizionati con l’ausilio della fluoroscopia fino al
Novembre 2009 ed i successivi 95 con la guida ecografica trans-rettale.
Risultati
L’analisi retrospettiva dei risultati ha mostrato che nel 46% dei 157 pazienti con tecnica fluoroscopica, si è
verificata una complicanza. Nel dettaglio, nel 17% si è verificata un’erosione della protesi, nel 11% una sua
infezione e nel 18% la sua rottura. Tali complicanze hanno necessitato un re-intervento nel 39% dei casi. Il
20% dei pazienti sottoposti a posizionamento con tecnica fluoroscopica era stato in precedenza radiotrattato.
Nel 47% dei pazienti appartenenti a questo sottogruppo, sono state osservate la rottura e/o l’erosione delle
protesi. Utilizzando come criterio di continenza l’impiego di 0-1 pad, solo il 46% dei pazienti trattati è
risultato continente nel postoperatorio. Il 16% del totale dei pazienti trattati utilizza più di 4 pads/die. Nei
pazienti sottoposti a posizionamento dei pro-ACT con guida ecografica una complicanza postoperatoria
è stata osservata nel 31% dei casi. Nel dettaglio, nel 11% si è verificata un’erosione della protesi, nel 5%
un’infezione delle protesi e nel 15% la rottura di una delle protesi. Tali complicanze hanno necessitato un
re-intervento nel 27% dei casi. Il 14% dei pazienti sottoposti al posizionamento con tecnica ecografica, era
stato in precedenza radio trattato. In questo sottogruppo si è osservato il 38% di complicanze in termini
di rottura ed erosione delle protesi. I risultati in termini di soggettiva percezione del miglioramento
dell’incontinenza hanno mostrato l’utilizzo di 0-1 pads solo nel 34% dei casi. Nell’11% dei casi totali è stato
riportato l’utilizzo di più di 4pads/die.
Discussione
L’evoluzione della tecnica mininvasiva di impianto dei ProACT® con l’utilizzo della guida ecografica
transrettale ha ridotto la gravità delle complicanze ed il numero di reinterventi. Tuttavia i risultati in
termini di miglioramento della continenza non sono tali da giustificare il pur sempre significativo tasso di
complicanze soprattutto nella popolazione radio trattata.
Conclusioni
I risultati a lungo termine dell’impiego di ProACT nel trattamento dell’incontinenza urinaria evidenziano un
elevato tasso di reintervento e complicanze postoperatorie in assenza di percentuali accettabili di successo
della metodica in termini di percentuale di pazienti continenti. I risultati osservati risultano peggiori nel
gruppo di pazienti radiotrattati.
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VIRTUE® MALE SLING FOR POST-PROSTATECTOMY STRESS INCONTINENCE:
SUBJECTIVE AND OBJECTIVE OUTCOMES WITH 1-YEAR FOLLOW-UP YEARS FOLLOW
UP
ANATOMIA DELLA VASCOLARIZZAZIONE PROSTATICA E IMPLICAZIONI NELLA
STRATEGIA NELLA EMBOLIZZAZIONE ARTERIOSA PROSTATICA PER IPB
D. Bottero, M. Ferro, D. Matei, A. Cioffi, G. Musi, S. Melegari, S. Detti, G. Galasso, G. Cordima, F.
Mazzoleni, A. Brescia, E. Dinang Cheguie, R. Bianchi, G. Matroprimiano, O. de Cobelli (Milano)
Aim of the study
Male stress urinary incontinence (SUI) after radical prostatectomy (RP) varies throughout the literature
ranging from 8-77% . A recent surgical device for treating postprostatectomy incontinence treatment option
includes Virtue quadratic male sling, consisting of a large pore knitted monofilament polypropylene mesh
with 2 pre-attached inferior (transobturator) extensions and 2 superior (prepubic) extensions.Evaluate
functional and anatomical outcomes as well as complications, 1year after the implantation of this new
device.
Between July 2012 and October 2012 , 29 patients (range 57-73 years old )treated with Virtue® Male were
included in this prospective non randomized study.All patients meeting the folllowing preoperative criteria:
history of prostate surgery,symptoms of low to moderate SUI assessed by clinical examination, urodynamic
diagnosis, adequate trial of nonsurgical treatment by pelvic floor exercise or physiotherapy. Patients
presenting severe incontinence or previous radiotherapy treatment were excluded from this evaluation.
The primary end point of this study is to assess the efficacy and safety of the surgical procedure based
on improvement after sling 1-year follow-up implantation in :24-hour pad weight , daily pad use , PGI-I
(Patient’s Global Impression) ,Questionnaire-short form [ICIQSF ] PAD 24 hours weight, ICIQ score were
analyzed using a fixed effect multivariate analysis of variance for repeated measures taking into account the
pre-op , 1 month, 3 months, 6 months and 12 months results as dependent variables and time as repeating
factor. For PPD the analysis was performed using the general estimating equation method
Results
Mean follow-up time was 14.5 months (range 12-22).Mean surgery time was 43,7 minutes .Significant
improvement of 24-hour pad weight ,ICIQ score, daily pad use , PGI-I were noted between baseline and last
follow up (P
Discussion
This quadratic technique has a potentially greater ability to provide urethral compression than does a purely
perineal or transobturator sling.
G. La Pera, P. Riu, S. Minucci (Roma)
Scopo del lavoro
la recente introduzione della embolizzazione arteriosa della prostata (PAE) nel trattamento della Ipertrofia
Prostatica Benigna rende la definizione delll’anatomia della vascolarizzazione prostatica un passaggio
fondamentale per l’esecuzione di questa metodica ancora sperimentale. Scopo del presente studio è definire
l’origine delle arterie prostatiche attraverso una analisi delle ANGIO TAC pelviche eseguite per studio
preliminare alla PAE, per embolizzazione in caso di emorragia irrefrenabile post turp e per patologie
vascolari
Materiali e metodi
Dopo approvazione del comitato etico di un protocollo di ricerca per la embolizzazione arteriosa della
prostata sono state eseguite 44 ANGIO TAC pelviche di cui 5 come studio preliminare della embolizzazione
arteriosa prostatica, 4 eseguite in corso di embolizzazione prostatica per ematuria irrefrenabile post turp 35
per patologie vascolari.
Risultati
la TC ha consentito in via preliminare di escludere nel 4,5 % dei casi la via di accesso per ostruzione
dell’arteria ipogastrica. L’origine delle arterie prostatiche è stata individuata dalla pudenda interna, dal
tronco comune della arteria vescicale superiore, dal tronco comune arteria gluteo-pudenda e più raramente
dalla arteria otturatoria
Discussione
la embolizzazione arteriosa della prostata deve ancora oggi essere considerata una metodica sperimentale
perché non è stata ancora dimostratata l’efficacia tuttavia la ricerca di nuove procedure miniinvasive, i
minori rischi operatori e l’assenza di danni alla sfera sessuale come la eiaculazione retrograda potrebbero
costituire il loro vantaggio principale.
Conclusioni
La complessità della vascolarizzazione prostatica rende l’identificazione della origine della arteria prostatica
con una ANGIO TC preliminare un passaggio fondamentale per la pianificazione della embolizzazione della
prostata
Conclusions
Virtue® Male Sling is an effective treatment option for low to moderate postprostatectomy incontinence
evidenced by objective improvements in 24-hr pad count and,pad weight and patient perceived success via
validated questionnaires
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ASSOCIAZIONE TRA LA STEATOSI EPATICA NON ALCOLICA (NALFD) E I SINTOMI DEL
BASSO TRATTO URINARIO (LUTS): RISULTATI DI UNO STUDIO TRASVERSALE
I LIVELLI INTRAPROSTATICI DI EME OSSIGENASI-1 SONO SIGNIFICATIVAMENTE
RIDOTTI NEI PAZIENTI AFFETTI DA LUTS MODERATO-SEVERI SECONDARI AD
IPERPLASIA PROSTATICA BENIGNA: STUDIO PILOTA
G. Russo, S. Cimino, E. Fragalà, S. Privitera, M. Madonia, T. Castelli, V. Favilla, G. Morgia (Catania)
Scopo del lavoro
Diversi studi hanno dimostrato l’associazione tra i Sintomi delle Basse Vie Urinarie (LUTS) e la presenza
di Sindrome Metabolica (MetS). Inoltre, la Steatosi Epatica Non Alcolica (NAFLD) è universalmente
conosciuta come la componente epatica della MetS. Diversi mezzi diagnostici non invasivi sono stato
proposti per studiare la NAFLD. Scopo del nostro studio è stato quello di valutare la prevalenza della
NAFLD nei pazienti affetti da LUTS e stabilire l’efficacia del Fatty Liver Index (FLI) nel predire la presenza
LUTS di grado moderato-severo.
Materiali e metodi
448 pazienti consecutivi affetti da LUTS sono stati arruolati in questo studio trasversale. I pazienti sono stati
valutati con l’IPSS e la MetS è stata classificata in accordo ai criteri dell’IDF. Sono stati altresì valutati il
FLI, il volume prostatico (PV), il PSA sierico, il testosterone totale (TT) e l’indice di omeostasi glucidica
(HOMA). Il FLI è stato calcolato tramite la seguente formula: FLI = e 0.953*loge (triglieridi) + 0.139*BMI
+ 0.718*loge (glutamiltransferasi) + 0.053*circonferenza vita - 15.745) / (1 + e 0.953*loge (trigliceridi) +
0.139*BMI + 0.718*loge (glutamiltransferasi) + 0.053*circonferenza vita - 15.745) * 100. Il Fatty Liver
Index (FLI) ≥40 è stato fissato come valore in grado di predire la steatosi epatica non alcolica (ROC= 0,81).
I pazienti, quindi, sono stati divisi in due gruppi: il Gruppo A (FLI
Risultati
Il Guppo B (FLI≥40) ha mostrato una prevalenza più alta di MetS, insulino resistenza (IR), LUTS di
grado moderato-severo, disfunzione erettile (DE), punteggi più alti al questionario IPSS sia nella fase di
riempimento che di svuotamento, PV, insulinemia, indice di resistenza insulinica (HOMA) e più bassi livelli
di TT e un punteggio basso di IIEF-5. La regressione logistica univariata ha dimostrato che il FLI, come
variabile continua (OR = 1.02, p
Discussione
: I risultati del nostro studio suggeriscono per la prima volta un’associazione tra NAFLD e LUTS. E’ noto
in letteratura che l’IR secondaria a MetS gioca un ruolo necessario nell’insorgenza della NAFLD. Questi
fattori sono anche associati con la presenza di LUTS. Infatti, i pazienti con FLI >40 presentano dei LUTS
più severi.
Conclusioni
I pazienti affetti da NAFLD dovrebbero essere considerati come una nuova popolazione a maggior rischio di
LUTS. Un valore di FLI pari o superiore a 40 può essere usato per determinare i soggetti con elevato rischio
di LUTS.
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G. Russo, L. Vanella, E. Fragalà, S. Privitera, V. Favilla, G. Li Volti, I. Barbagallo, V. Sorrenti, S. Cimino, G.
Morgia (Catania)
Scopo del lavoro
L’eme ossigenasi-1 (HO-1) è una proteina endoplasmatica responsabile della rimozione dei radicali liberi
dell’ossigeno e dell’inibizione dell’apoptosi. Diversi livelli di evidenza suggeriscono che l’incremento del
tessuto adiposo e la Sindrome Metabolica (MetS) possono sopprimere l’espressione dell’HO-1. Lo scopo
del nostro studio è stato quello di valutare l’associazione tra i livelli intraprostatici di HO-1, HO-2 ed HOenzimatica in pazienti affetti da LUTS di grado severo secondari ad ostruzione cervico-uretrale e sottoposti a
TURP.
Materiali e metodi
132 pazienti consecutivi con IPSS ≥12, PSA < 4 ng/ml o PSA > 4 ng/ml ma biopsia prostatica negativa,
Qmax < 15 mL/sec, volume prostatico tra 30 ml e 80 ml, sono stati arruolati e sottoposti a TURP. La
presenza di MetS è stata definita in accordo ai criteri IDF. I soggetti sono stati categorizzati in 3 gruppi
in relazione alle seguenti alterazioni: Gruppo A (HDL-C≥40 mg/dl e trigliceridi 150 ng/ml). Per ciascun
paziente sono stati raccolti 3 differenti campioni di adenoma prostatico prelevati casualmente ed utilizzati
per la determinazione dei livelli di HO-1, HO-2 ed HO-enzimatica. Il protocollo è stato approvato dal
comitato etico locale (ID: 578/12). I livelli di HO-1 sono stati misurati mediante tecnica di ELISA (Enzo
Life Sciences, Plymouth Meeting, PA), mentre l’HO-2 e l’HO-enzimatica tramite western blotting.
Risultati
75 pazienti (56.8%) erano affetti da MetS mentre 57 (43.2%) erano normali. L’analisi istologica ha rilevato
la presenza di iperplasia prostatica benigna in tutti i pazienti. Comparando i pazienti affetti da MetS con
quelli normali, abbiamo osservato delle differenza significative di HO-1 (5.29 vs. 6.28; p=0.04), HO-2 (1.01
vs. 1.83, p
Discussione
Abbiamo dimostrato come la MetS abbassi significativamente i livelli intraprostatici di HO-1, HO-2 ed HOenzimatica Le alterazioni dei trigliceridi e delle HDL sembrano essere associate con queste riduzioni. Questi
risultati confermano la stretta associazione tra MetS e LUTS secondari ad IPB ed il ruolo significativo
dell’HO in questa patologia.
Conclusioni
Strategie interventistiche mirate alla correzione del profilo lipidico ed il conseguente miglioramento della
MetS possono influenzare positivamente i LUTS secondari ad IPB.
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L’INSULINO-RESISTENZA è UN FATTORE PREDITTIVO DI DISFUNZIONE ERETTILE E DI
SINTOMI DEL BASSO TRATTO URINARIO: RISULTATI DI UNO STUDIO TRASVERSALE
LA FLOW-MEDIATED DILATION DELL’ARTERIA BRACHIALE ED I SINTOMI DEL BASSO
TRATTO URINARIO: SONO FRA LORO CORRELATI?
S. Cimino, G. Russo, E. Fragalà, S. Privitera, T. Castelli, M. Madonia, V. Favilla, G. Morgia (Catania)
S. Masciovecchio, P. Saldutto, E. Toska, V. Galica, D. Biferi, C. Cicconetti, G. Giovanditti, G. Paradiso
Galatioto, C. Vicentini (L’Aquila)
Scopo del lavoro
Diversi studi hanno dimostrato l’associazione tra sintomi del basso tratto urinario (LUTS), la disfunzione
erettile (DE) e la presenza di insulino-resistenza (IR) in soggetti con Sindrome Metabolica (MetS). Lo scopo
dello studio è stato quello di determinare la relazione tra insulino-resistenza, disfunzione erettile e i LUTS e
dimostrare se l’insulino-resistenza possa essere considerato un fattore predittivo di disfunzione erettile e di
LUTS di grado severo.
Materiali e metodi
Tra il gennaio 2008 e il gennaio 2013 sono stati valutati 544 pazienti consecutivi affetti LUTS secondari
ad iperplasia prostatica benigna (IPB) con LUTS ad essa correlata. La funzione sessuale e i sintomi del
basso tratto urinario sono stati valutati attraverso l’uso di questionari validati: l’International Index of
Erectile Function (IIEF) e l’International Prostate Symptom Score (IPSS). I pazienti sono stati considerati
affetti da sindrome metabolica in accordo a quanto definito dalla Federazione Internazionale del Diabete,
considerando affetti da insulino-resistenza i pazienti con HOMA Index ≥ 3. E’ stata eseguita una regressione
logistica univariata e multivariata con l’obiettivo di valutare i fattori predittivi di LUTS severi (IPSS score
≥20) e di disfunzione sessuale (IIEF-EF
Risultati
I pazienti affetti da insulino-resistenza avevano un punteggio più alto al questionario IPSS (19.0 vs. 15.0; p
Discussione
I risultati del seguente studio suggeriscono che l’IR secondaria alla MetS è associata alla presenza di LUTS
secondari ad IPB ed a DE, e dovrebbe essere considerata come target al fine di contrastare la crescita
prostatica.
Conclusioni
I pazienti con insulino-resistenza hanno un rischio più elevato di manifestare LUTS severi e di essere affetti
da disfunzione erettile: è auspicabile quindi un una correzione dell’IR al fine di ridurre questo rischio.
Sarebbero utili, quindi, studi osservazionali per meglio comprendere l’associazione tra IR, LUTS e DE.
Scopo del lavoro
Recenti evidenze scientifiche mostrano come alterazioni della biodisponibilità l’ossido nitrico (nitric oxide
–NO) sono almeno in parte correlabili all’insorgenza dei sintomi del basso tratto urinario (lower urinary
tract symptomps – LUTS). La flow-mediated dilation (FMD) dell’arteria brachiale costituisce la tecnica non
invasiva più utilizzata per studio della disfunzione endoteliale NO-correlata. Scopo del nostro lavoro è stato
quello di comparare la FMD dell’arteria brachiale di soggetti sani con quella di pazienti affetti da LUTS.
Materiali e metodi
Abbiamo reclutato per il nostro studio 51 soggetti non affetti da LUTS (GRUPPO A) e 47 pazienti (pz)
affetti da LUTS correlabili all’ ipertrofia prostatica (benign prostatic enlargement – BPE) (GRUPPO B)
non fumatori e non affetti da patologie endocrino-metaboliche. Tutti i pz oggetto di studio hanno compilato
il questionario IPSS (International prostatic symptoms score) e sono stati sottoposti a FMD brachiale.
L’esecuzione di tale metodica prevede la valutazione ecografica del diametro medio dell’arteria brachiale in
condizioni di riposo e dopo 60-90 secondi dalla desufflazione rapida di un manicotto di sfigmomanometro
precedentemente gonfiato per 5 minuti a pressione elevata (250 mmHg). La FMD è stata calcolata come
differenza percentuale (%) fra il massimo diametro post-ischemico e il diametro medio basale.
Risultati
L’età mediana dei soggetti sani e dei pazienti affetti da BPE/LUTS è stata rispettivamente di 51 anni
(range 45-55) e di 56 anni (range 50-62). Lo score mediano al questionario IPSS rilevato per i soggetti del
GRUPPO A e dei pazienti del GRUPPO B è stato rispettivamente di 2 e 31. In 48 soggetti del GRUPPO A
(94,1%) abbiamo osservato una FMD maggiore del 10%. In 3 soggetti (5,9%) abbiamo rilevato una FMD
inferiore al 10% ma sempre maggiore del 5%. In 45 pz del GRUPPO B (95,7%) abbiamo rilevato una FMD
inferiore al 10% di cui 35 (74,4%) con una FMD inferiore al 5%. In 2 pz affetti da BPE/LUTS (4,3%) la
FMD era superiore al 10%.
Discussione
Una consolidata letteratura dimostra che una FMD brachiale inferiore al 10% è causata da una alterazione
della sintesi/rilascio dell’NO endoteliale e correla con diverse patologie cardiovascolari e metaboliche. Sono
presenti in letteratura soltanto pochi studi che hanno dimostrato una connessione fra patologie uro-genitali
NO-correlate e la FMD. Alcuni studi hanno evidenziato una interdipendenza fra la presenza ed il grado del
deficit erettile e una ridotta FMD dell’arteria brachiale. Nessuno studio era stato finora condotto al fine di
comparare la FMD brachiale di soggetti sani con quella di pz affetti da LUTS. I nostri risultati evidenziano
che i pazienti affetti da LUTS presentano ridotte FMD brachiali a conferma della presenza di disfunzione
endoteliale NO-correlata.
Conclusioni
La nostra esperienza dimostra che esiste una correlazione fra la ridotti valori della FMD dell’arteria
brachiale ed i LUTS, entrambe condizioni caratterizzate da disfunzione endoteliale NO-correlata.
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METABOLIC SYNDROME CAN BE ASSOCIATED WITH PERSISTENT STORAGE SYMPTOMS
AFTER TREATMENT OF LUTS DUE TO BPH
METABOLIC SYNDROME CAN INCREASE PROSTATE VOLUME AND MODIFY THE
PROSTATIC SHAPE: RESULTS OF A MULTICENTER STUDY
M. Salvi, A. Sebastianelli, A. Cocci, A. Tubaro, C. De Nunzio, L. Vignozzi, M. Maggi, M. Carini, S. Serni,
M. Gacci (Firenze)
A. Sebastianelli, M. Salvi, T. Jaeger, A. Tubaro, C. De Nunzio, L. Vignozzi, M. Maggi, M. Carini, S. Serni,
M. Gacci (Firenze)
Aim of the study
Several preclinical and clinical evidences suggested the association between Metabolic Syndrome (MetS)
and lower urinary tract symptoms (LUTS) due to benign prostatic enlargement (BPE). The aim of our study
is to evaluate the impact of MetS components on urinary outcomes after surgical treatment for BPE
Aim of the study
Several epidemiological data and preclinical evidences underline the potential role of metabolic syndrome
(MetS) in the development and progression of benign prostatic hyperplasia (BPH). The aim of our study is
to evaluate the effect of MetS construct, as well as of its individual MetS components, on the growth of the
overall prostate volume (PV), and its related diameters, in men treated with transurethral (TURP) or open
(OP) prostatectomy for BPH.
We evaluated a non-selected consecutive population of 378 men (mean age 68) surgically treated with
simple open prostatectomy (OP) or transurethral resection of the prostate (TURP) for severe LUTS due
to large BPE in two tertiary referral centers. Age, prostate volume (PV) and all MetS parameters (waist
circumference [WC], Triglycerides, HDL cholesterol, blood pressure and fasting glucose), defined according
to NCEP-ATPIII criteria, were recorded at recovery. LUTS were scored by total (tot-IPSS), voiding (voiIPSS) and storage (sto-IPSS) IPSS: for all men data were recorded 3 months after surgery. Spearman’s
correlation coefficient was used for univariate analyses, whereas multiple linear or logistic analysis were
used for multivariate analyses, as appropriate
A total of 378 consecutive men (mean age 68) treated with TURP or OP for severe LUTS refractory to
medical treatment were selected in two tertiary referral centers. The main diameters of the prostate (AP:
antero-posterior; CC: cranio-caudal; LL: latero-lateral) were measured by TRUS and the PV was calculated
using the ellipsoid formula (D1xD2xD3xπ/6). Metabolic syndrome was defined according to NCEP-ATPIII
criteria. Spearman’s correlation coefficient was used for univariate analyses, while multiple linear or logistic
analysis were used for multivariate analyses.
Results
Overall, 140 men (37.0%) satisfied MetS criteria. The improvement of Total and sto-IPSS postoperatively
was related with surgical procedure, PSA and Waist circumference (WC). The number of MetS parameters
were correlated with postoperative storage IPSS scores (adjusted r=0.162, p=0.008). Moreover, significant
differences in delta tot-IPSS score and delta sto-IPSS score between men with or without MetS have been
detected (63.2 vs. 81.7, p=0.015 and 19.6 vs. 63.6, p=0.013, respectively, see Figure 1). TURP and WC>102
cm were associated with an higher risk of an incomplete recovery of tot-IPSS (OR: 0.273, p=0.006; OR:
0.288, p=0.010) and Storage IPSS (OR: 0.206, p=0.002; OR: 0.149, p=0.001) as compared to OP and WC
Results
Among 378 men, 140 (37.0%) were affected by MetS. PV and all diameters - in particular the AP - were
significantly and positively associated with the number of MetS parameters (Figure A,B), even after
adjustment for age, BMI and the use of 5-alpha reductase inhibitors (p=0.005 and p=0.002 for PV and AP
diameter respectively, p=0.02 for CC and LL diameters). High serum triglycerides and low serum HDLcholesterol levels were significantly associated with prostate volume (Figure C,D), even after adjustment for
the aforementioned confounders and MetS severity. In particular, men with MetS had a higher risk of having
a prostatic volume >60cc than those without MetS (HR=2.4, CI: 1.441-4.095, p
Discussion
Men with MetS comorbid to LUTS, and, in particular those with WC≥ 102cm, showed worse urinary
function recovery after any treatment for BPH. The storage symptoms were less decreased after TURP or OP
in men with MetS and in particular in those with WC≥102
Discussion
The presence of MetS is associated with a remarkable increase of prostate volume and a concomitant,
component-dependent, modification of prostatic shape.
Conclusions
The presence of MetS should be considered before surgery for LUTS/BPH, to improve MetS patient
counseling
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Conclusions
These data suggest that MetS is an important determinant of BPH progression and underline the importance
of assessing MetS in men with severe LUTS/BPH.
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PREVALENCE OF SUBJECTIVE LOWER URINARY TRACT SYMPTOMS ACCORDING
TO SEXUAL ORIENTATION - FINDINGS OF A REAL-LIFE SURVEY IN A COHORT OF
CAUCASIAN-EUROPEAN MEN
SUBJECTIVE LOWER URINARY TRACT SYMPTOMS ACCORDING TO HEALTHSIGNIFICANT COMORBIDITIES BURDEN - FINDINGS OF A REAL-LIFE SURVEY IN A
COHORT OF CAUCASIAN-EUROPEAN MEN
L. Boeri, E. Ventimiglia, A. Serino, M. Colicchia, G. Castagna, P. Capogrosso, C. Regina, M. Paciotti, A.
Briganti, R. Damiano, F. Montorsi, A. Salonia (Milan)
G. La Croce, P. Capogrosso, E. Ventimiglia, M. Colicchia, A. Serino, L. Boeri, G. Castagna, F. Castiglione,
A. Russo, M. Paciotti, A. Briganti, F. Cantiello, R. Damiano, F. Montorsi, A. Salonia (Milan)
Aim of the study
We sought the prevalence of and severity of LUTS in a cohort of Caucasian-European men seeking first
medical help for uro-andrologic purposes other than LUTS, according to sexual orientation (SO).
Aim of the study
To assess prevalence and severity of lower urinary tract symptoms (LUTS) in a cohort of CaucasianEuropean men seeking first medical help for uro-andrologic purposes other than LUTS, according to their
clinical relevant comorbidities burden.
Sociodemographic, clinical and psychometric data from 1103 consecutive individuals were analysed.
Subjective perception of LUTS was measured by the International Prostate Symptom Score (IPSS). Men
with storage symptoms scored 1-3 and ≥4 (of 15), and voiding symptoms scored 1-4 and ≥5 (of 20) were
considered as having mild and moderate-to-severe symptoms, respectively. For individual symptoms,
patients were assessed as symptomatic if their score was ≥1 (Apostolidis A, et al. Eur Urol 2009;56:937-47).
Health-significant comorbidities were scored with the Charlson Comorbidity Index (CCI; categorized 0 vs 1
vs ≥2). Descriptive statistics and logistic regression models tested the association between LUTS and SO.
Results
Complete data collection was available for 165 (14.9%) men who have sex with men (MSM) [mean (SD)
age: 41.8 (14.1) yrs; range: 17-73] and 938 (85.1%) heterosexual individuals [age: 40.4 (12.3) yrs; range:
17-77]. MSM and heterosexual men were age-comparable (difference: -1.4; p=0.19). MSM and heterosexual
individuals did not differ in terms of total IPSS score. Conversely, MSM showed higher rates of mild (49.4%
vs 29.3%; χ2: 25.01; p<0.001).
Discussion
Numerous studies have indicated that MSM are at increased risk for poor health due to various social and
behavioural factors. Owing to casual sex, MSM are more frequently diagnosed with sexually transmitted
infections (STI) and STI related disease as compared to general population. Prevalence and severity of
LUTS according to male SO have been scantly analysed. This is the first retrospective major study with the
aim to investigate the effects of SO on voiding and storage symptoms.
Conclusions
Current findings suggest a higher prevalence of storage and voiding symptoms according to male sexual
orientation, in a cohort of age-comparable Caucasian-European men not specifically seeking medical help
for LUTS.
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Sociodemographic, clinical and psychometric data from 938 consecutive heterosexual individuals were
analysed. Subjective perception of LUTS was measured by the International Prostate Symptom Score
(IPSS). Men with storage symptoms scored 1-3 and ≥4 (of 15), and voiding symptoms scored 1-4 and ≥5
(of 20) were considered as having mild and moderate-to-severe symptoms, respectively. For individual
symptoms, patients were assessed as symptomatic if their score was ≥1 (Apostolidis A, et al. Eur Urol
2009;56:937-47). Health-significant comorbidities were scored with the Charlson Comorbidity Index (CCI;
categorized 0 vs 1 vs ≥2). Descriptive statistics and logistic regression models tested the association between
LUTS and CCI score.
Results
Mean (SD) patients age was 40.4 (12.3) yrs. Of all, CCI was 0, 1 or ≥2 in 795 (84.8%), 30 (3.2%) and 113
(12.0%) men, respectively. No significant age difference was found among aforementioned groups. Total
IPSS score did not vary according to CCI scores. Conversely, higher rates of both mild (M) and moderateto-severe (S) storage LUTS were observed in men with CCI≥2 (M: 38.9%; S: 38.1%) or CCI=1 (M: 36.7%;
S: 23.3%) as compared with those with CCI=0 (M: 27.7%; S: 19.0%; χ2: 40.7; p
Discussion
A higher CCI may be considered a reliable proxy of a lower general health status. Our results confirmed the
hypothesis that the lower urinary tract health is strictly related to the general health status of the patients.
Conclusions
Current findings showed a higher prevalence of subjective storage and voiding symptoms according to
health-significant comorbidities burden, in a cohort of Caucasian-European men not even specifically
seeking medical help for LUTS.
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APPROPRIATE PROPHYLACTIC ANTIBIOTIC USE FOR PATIENTS TO UNDERGO
UROLOGICAL SURGERY REDUCES DIRECT AND INDIRECT COSTS
COMPARISON OF OUTCOMES IN THULLIUM LASER PROSTATECTOMY BETWEEN PURE
BLADDER OUTFLOW OBSTRUCTION AND COEXISTENCE OF DETRUSOR OVERACTIVITY.
T. Cai, D. Tiscione, G. Malossini, N. Mondaini, F. Meacci, S. Mazzoli, R. Bartoletti (Trento)
F. Marson, F. Soria, A. Gurioli, P. Destefanis, B. Lillaz, G. Casetta, B. Frea.
Aim of the study
The adherence to European Association of Urology (EAU) guidelines concerning prophylactic antibiotics
reduces the surgical site infection rates and emergence of resistant bacterial strains. However, the
compliance with EAU guidelines in urological surgery is not optimal. The aim of this study was to evaluate
the costs saving due to complete adherence to EAU guidelines in a tertiary referral urological institution.
Aim of the study
In January 2011, we started a protocol of complete adherence to EAU guidelines for antibiotic prophylaxis
in all surgical urological procedures. From January 2011 to October 2013, data from 2,879 surgical
urological procedures have been collected and compared with 3,112 procedures obtained before agreeing
recommendations for best practice. The direct and indirect costs related to surgical site infection were the
outcome measurements. Chi-square or Fisher’s exact tests were used.
Results
The adherence to EAU guidelines was high (87%). The rate of surgical site infection is quite similar between
the two periods, without any statistically significant difference (3.5% vs 4.1%). The costs related to drugs
amounted to 36,700 Euro and the indirect costs to 29,560 Euro. In the 3 years before, the costs related to
drugs amounted to 76,980 Euro and the indirect costs to 45,870 Euro. We observed a statistically significant
reduction in terms of direct and indirect costs between the two periods (p
to assess outcomes of Thullium laser prostatectomy dividing patients, evaluated by urodynamics, into two groups: first group made
of pure obstruction at voiding time, second group made of obstruction and detrusor overactivity (DO).
we retrospectively analyzed 22 patients undergone Thullium laser prostatectomy. They were evaluated with urodynamics to better
clarify their voiding and empting disfunctions.
At the moment of urodynamics 8 patients were taking both alpha blockers and 5-alpha reductase inhibitors (combination therapy),
while 12 patients were taking only alpha blockers and 2 patients were taking only 5-alpha reductase inhibitors. All patients had
severe symptom index at International prostate symptom score (I-PSS) , and urgency was always complained. Urodynamics showed
DO with phasic waves in 9 patients (41%), whereas 13 patients (59%) had stable detrusor function. All patients were obstructed at
voiding time with Schafer grades from III to VI. TRUS showed enlarged prostate in all cases, with a mean prostatic volume of 65
gr (range from 40 to 120), and all underwent Thullium laser prostatectomy. 22 patients were discharged in first post operative day
without complicationes, 2 patients in third postoperative day (grade I according to Clavien Dindo Scale). All patients were revisited
in clinic two months after surgical operation.
Results
all patients (100%) referred significant urinary flow improvement 2 months after surgery. Patients with stable detrusor function had
not de novo urgency; of 9 patients with DO, 4 (44%) referred urgency disappearance, whereas 5 patients (56%) referred persistence
of urgency. Urgency was treated with anticholinergic drugs in 3 cases, whereas in 2 cases no drugs was prescribed. At six month
after surgery no patient had urgency, irrespective of anticholinergic drugs, with complete recovery.
Discussion
Discussion
Our study shows that the complete adherence to European Association of Urology guidelines concerning
prophylactic antibiotics for all surgical urological procedures protocol, reduces the direct and indirect costs
without any significant difference in terms of surgical site infection.
Conclusions
In this report we analyzed the impact of complete adherence to European Association of Urology guidelines
concerning prophylactic antibiotics for all surgical urological procedures in cost saving. We found that the
adherence to guidelines reduces the direct and indirect costs in all urological procedures. The adherence to
EAU guidelines is, then, the right way to costs reducing and improves the antibiotic stewardship.
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when improvement of quality of life is the first purpouse of a surgical operation it becomes essential to predict outcomes. DO
can coexist or not in patients with urodynamic voiding obstruction; our study shows that, in patients treated with miniinvasive
techniques like Thullium laser prostatectomy, DO is present in about 40% of cases, and urgency as symptom due to DO can go on
for some months after surgery. DO is understood as a consequence of obstruction needing a period of time before self-resolving.
When pure obstruction is present one month postoperative evaluation usually shows complete recovery.
Conclusions
urinary urgency can persist for some months after Thullium laser prostatectomy in patients with both DO and bladder outflow
obstruction. This usually doesn‘t need additional pharmacological treatment, and a period of six months can be necessary to get
complete recovery.
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ANALYSIS OF EARLY COMPLICATIONS OF 532NM PVP FOR BENIGN PROSTATE
OBSTRUCTION (BPO) DURING THE FIRST 50 CASES OF LEARNING CURVE COMPARED
TO LAST 50 THUVAP/THUVEP IN THE SAME INSTITUTION
CLINICAL COURSE OF PATIENTS RECEIVING ANTI-PLATELETS THERAPY WHO
UNDERWENT THULIUM LASER ENUCLEATION OF THE PROSTATE.
P. Destefanis, G. Melloni, F. Pisano, F. Marson, A. Battaglia, M. Allasia, A. Bosio, A. Bisconti, G. Casetta, P.
Gontero, B. Frea (Torino)
Aim of the study
Benign prostate obstruction (BPO) can be treated with a range of laser treatments. Learning curve of laser
treatments has been discussed but there are still many controversies. The aim of this work is to assess the
safety of 532nm photoselective vaporization of prostate (PVP) during the first 50 procedure of the learning
curve and to compare it to the safety of another laser treatment (ThuVAP-ThuVEP) already introduced and
well experienced, in the same Institution.
The first 50 patients treated with PVP (GreenLight™ 180-W XPS) were included. Data were compared to
the last 50 (of more than 300) patients undergone to ThuVAP/ThuVEP and morcellation (Revolix 120W®
and Piranha® morcellator) at our Institution. The PVP patients were all treated by the same surgeon during
his learning curve. The 50 ThuVEP patients were treated by different experienced surgeons. The following
data were analyzed: age, prostate volume, antiplatelet drugs, duration of laser, operative times, energy
delivered, post-operative hospital stay, blood transfusions, ER re-admission, post-operative urinary retention,
fever and infections. All the complications were graded according Clavien-Dindo classification.
Results
The 50 PVP patient (Group A) were treated from November 2013 to March 2014, the 50 ThuVEP (35 with
morcellation) patients (Group B) were treated from January 2013 to July 2013. Mean age was 69+9y for
Group A and 69+7y for Group B(p=0.710). The mean prostate volume resulted 70+35ml for Group A and
61+27ml for Group B (p=0.151). 17 patients of group A and 16 of group B were under anti platelet drugs
(p=0.8). Mean energy delivered resulted 279+171 kJ for Group A and 178+92 for Group B (p=0.003). Mean
laser duration resulted 29 min for each group while total endoscopic duration was 80 min for group A and
110 min for group B (p=0,001) Mean post-operative stay resulted 1.48 days and 1.49 respectively (p=0.98).
Post-discharge ER admission occurred in 9 pts of group A and in 13 of Group B (p=0.334). Fever and
urinary infections occurred in 3 pts of each group, and urinary retention in 5 pts of each group. Haematuria
occurred in 5 and 7 patients respectively (p=0,759). Two patients of group B required blood transfusions.
One patient of group A experienced a chest pain that required deferral to Cardiology Dept. According
Clavien-Dindo classification we recorded: Group A: grade 1: 8 pts, grade 2 3 pts; Group B: grade 1: 11 pts,
grade 2: 4 pts, grade 3b 2 pts.
Discussion
The two groups resulted comparable for age, volume of the prostate and use of anti-platelet drugs. PVP
required a significantly higher laser energy with shorter operative time. PVP, even if in the learning curve,
proved to be as safe as another laser treatment (ThuVEP) performed by experienced surgeons. In particular,
we underline that no PVP patient required blood transfusions.
S. Picozzi, A. Macchi, C. Marenghi, G. Bozzini, S. Maruccia, D. Ratti, B. Osmolovskiy, A. Kamalov, L.
Carmignani (Milano)
Aim of the study
With the progressive ageing of the population, the prevalence of vascular disease as the prevalence of benign
prostatic enlargement is increasing. In recent years, laser prostatectomy is emerging as a replacement for the
standard transurethral resection of prostate (TURP). The aim of this study was to evaluate the clinical course
of patients receiving anti-platelets therapy who underwent Thulium Laser Enucleation of the Prostate.
A cooperation between the University of Milan and Moscow was settled. From September 2011 we start a
prospective study on patients who underwent ThuLEP. All candidates for surgical therapy of lower urinary
tract symptoms (LUTS) and obstruction due to a BPH. This work evaluated the surgical outcomes of 42
ThuLEP in patients taking anti-platelet therapy to 50 procedures performed in patients who have never taken
anti-platelet agents before surgery.
Results
The study group included 39 patients who had been on anti-platelet monotherapy with ASA 100 – 300 mg
and 3 in Ticlopidine. In the study group 37 procedures (88%) were performed under spinal anaesthesia,
while 5 were performed under general anaesthesia. There was not a significant difference in operative
time. A comparison test between groups was not statistically significant with regards to the decrease in
hemoglobin concentration. Transfusional support was required in one procedures performed in patients
taking anti-platelet therapy, and in no procedures in controls. There were no adverse cardiac events
(myocardial infarction, angina, cardiovascular failure, hypovolemic shock). One patient in the treatment
group required re-intervention to ensure hemostasis. During this period one case of haematuria happens two
week in every of the two group that was treated conservatively. No further bleeding or cardiac events were
recorded.
Discussion
In this study we demonstrated for the first time that patients undergoing ThuLEP, who continued taking antiplatelet agents had no a significantly increased incidence of perioperative bleeding-associated morbidity
compared with those who were not taking any anti-platelet medication.
Conclusions
ThuLEP can be performed in patients taking anti-platelet agents without increased of perioperative bleedingassociated morbidity.
Conclusions
PVP treatment of BPO proved to be safe also in the first cases of the learning curve.
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Prostatic artery embolization for prostate volume greater than 80 cc:
HOLEP (HOLMIUM LASER ENUCLEATION OF PROSTATE) FOR MANAGING BENIGN
PROSTATIC HYPERPLASIA OF > 100 ML: FUNCTIONAL RESULTS AT 1 YEAR OF FOLLOWUP.
results from a single-center prospective study
Aim of the study
To investigate clinical benefits and safety of prostatic artery embolization (PAE) in subject with prostate
volume ≥ 80 cc and Charlson Comorbidity Index (CCI) ≥ 2 and affected by benign prostatic obstruction
(BPO).
From January 2009 to January 2012 PAE was performed in 88 consecutive patients affected by clinical BPO.
Inclusion criteria were: symptomatic BPO refractory to medical treatment, IPSS ≥ 12, total prostate volume
(TPV) ≥ 80 cc, Qmax < 15 mL/sec and CCI ≥ 2. Primary end-points were the reduction of 7 points of the IPSS
and the increase of Qmax. Secondary end-points were the reduction of TPV, post-void residue (PVR), PSA,
IIEF-5 and IPSS-QoL. Follow-up was addressed at 3-, 6-months and at 1 year.
Results
Of all patients enrolled, 88 completed the procedure. Of these, 51 (57.95%) e 37 (42.05%) had a Charlson
Comorbidities Index =2 e ≥3 respectively. All patients were discharged with a visual analog Score of 0 out
of 12. The mean IPSS (10.40 vs 23.98; p<0.05) and the mean Qmax (16.89 vs. 7.28; p<0.05) at 1 year were
significantly different respect to baseline. When considering secondary end-points, we observed significant
variation in terms of PVR (18.38 vs. 75.25; p<0.05), TPV (71.20 vs. 129.31; p<0.05) and PSA (2.12 vs. 3.67;
p<0.05) at 1 year compared with baseline. Finally, the mean IPSS-QoL significantly changed from baseline to
1 year after PAE (5.10 vs. 2.20; p<0.05). No minor or major complications were reported.
Discussion
All these findings could be explained by the reduction of blood flow of prostatic arteries leads to an ischemic
necrosis and consequent prostate volume reduction, and consequent improving of peak flow and reducing of
PSA, IPSS and PVR. Although PAE costs analysis are lacking in the literature we may suppose that it could
be more cost effective therapies. In fact, Based on our results, we could affirm that some advantages of PAE
could be the minimally invasive procedure and the significant reduction of LUTS/BPO related symptoms and
improving of urinary flow, with short hospitalization and limited complications and furthermore by significant
improvement of quality of life.
F. Di Loro, M. Spurio, A. Del Grasso, M. Mencarini, A. Macchiarella, C. Dattilo, F. Rubino, F. Blefari
(Prato)
Scopo del lavoro
Holmium laser enucleation of the prostate (HoLEP) is an efficient procedure for the treatment of men
suffering from the obstructive symptoms of BPH Several study supports the hypotesis that HoLEP is an
ideal endoscopic surgical treatment form men with large prostates. In this study we report our experience
whit HoLEP in patients with symptomatic BPH resulting from large prostate (> 100 ml).
Materiali e metodi
A total of 505 patients with lower urinary tract symptoms due to an enlarged prostate underwent Holep
between May 2008 and January 2014. 74 patients with a prostate volume greater then 100 ml who
underwent HoLEP at our institution where included in this retrospective. The preoperative prostate volume
are measured by sovrapubic ultrasound: mean volume 144 cc (105 -320 cc). All HoLEP procedures were
performed by one surgeon with considerable experience in this technique. The clinical and functional
outcomes were assessed at 1, 3, 6 e 12 months postoperatively using: the International Prostate Symptom
score (IPSS), Quality of Life (QoL) score, Maximum flow rate (Q max) and post void residual urine (PVR).
Risultati
The mean age 70,4 (51-88) years.The mean weigth of resected tissue was 99.2 (61-254) gr. At follow-up
the patients had a significant improvement from baseline in IPSS, QoL, Qmax and PVR. There has been a
steady improvement in these parameters during follow-up.
Discussione
The mean age 70,4 (51-88) years.The mean weigth of resected tissue was 99.2 (61-254) gr. At follow-up
the patients had a significant improvement from baseline in IPSS, QoL, Qmax and PVR. There has been a
steady improvement in these parameters during follow-up.
Conclusioni
Holep represents a safe and effective endoscopic treatment for patients with symptomatic larges prostates
who traditionally required open prostatectomy. However, to be come comfortable performing Holep in large
prostates a prolonged learning curve is required.
Conclusions
We showed clinical benefits of PAE for the treatment of LUTS/BPO by reducing IPSS, TPV, PSA, PVR and
improving of urinary flow and QoL after 1 year in prostate volume ≥ 80 cc and in patients with CCI ≥2.
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Transurethral resection of the prostate in patient with detrusor
underactivity : surgical outcomes
LONG-TERM CHANGES IN SERUM PROSTATE SPECIFIC ANTIGEN (PSA)
CONCENTRATION IN PATIENTS SUBMITTED TO EITHER TRANS-URETHRAL RESECTION
(TURP) OR HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP)
BACKGROUND AND OBJECTIVE
Detrusor underactivity (DU) is one of the causes of male lower urinary tract symptoms. In our study we have
evaluated the effectiveness of transurethral resection of the prostate (TUR-P) in patients with urodynamic
diagnosis of DU.
From February 2010 to June 2013, we enrolled 46 patients affect to DU with bladder contractility index
(BCI) ≤ 100, peak flow (Qmax) ≤ 12 ml /s and Bladder Outlet Obstruction Index (BOOI) ≤ 40. TUR-P by
bipolar plasmakinetic resector was performed for all patients, by the same operator. All patients completed the
questionnaire International Prostate Symptom Score (IPSS) and were subjected to urodynamic examination
before surgery and 6 months after surgery.
RESULTS
It was found a stastically significant improvement (p <0.05) of IPSS, Qmax and post-voided residual after
surgery. No statistical differences were reported in other urodynamic parameters considered; however, in 14
patients (30.5%) was observed an increase in Pdet Max to follow-up.
DISCUSSION
The recent literature shows that the transurethral endoscopic surgery is an appropriate treatment for cases of
DU associated with bladder outlet obstruction; few studies with non-unique outcomes have been conducted
to prove the role of endoscopic surgery in the treatment of patients suffering exclusively from DU. In the
presence of DU, however, the detrusor pressure fails to rise sufficiently and BOO can be difficult to diagnose
and some patients are classified as “non obstructed.” When the urethral resistance is reduced due to the
TUR-P, even at low detrusor pressure can complement the process of bladder emptying. The improvement of
Pdetmax could be attributed to improved contractility of the bladder after surgery.
CONCLUSION
Although within the limits of the small sample size, our experience has shown that the TUR-P is effective to
improve IPSS and urodynamic parameters in patients with DU urodynamic diagnosis was not associated with
BOO.
G. La Croce, G. La Croce, P. Capogrosso, M. Colicchia, E. Ventimiglia, L. Boeri, A. Russo, F. Castiglione,
G. Castagna, A. Briganti, F. Cantiello, R. Damiano, F. Montorsi, A. Salonia (Milan)
Aim of the study
Assess long-term changes in PSA values in patients treated with HoLEP vs TURP for bladder outlet
obstruction associated with benign prostate hyperplasia (BPH).
Complete clinical, prostate morphometric, and PSA values data from 99 patients submitted to HoLEP and
102 patients submitted to TURP with a follow-up (FU) > 4 years were analyzed. All patients completed a
remembered (= targeting a date preceding surgery) and a real-time (= targeting the 4 weeks prior to survey)
IPSS. Descriptive statistics tested the differences between the two groups. Logistic regression models tested
the association among potential clinical and pathologic predictors and long-term postoperative PSA values
changes in both groups.
Results
Mean (SD; range) age at surgery was 65.1 (6.8; 47-78) and 65.1 (7.9; 48-84) yrs, for patients submitted to
HoLEP vs TURP, respectively (p>0.05). Mean (SD; range) FU was 67.7 (6.9; 57.6-80.4) and 66 (6.3; 56.479.2) months for patients submitted to HoLEP vs TURP, respectively (p>0.05). HoLEP patients showed
higher mean preoperative prostate volumes than TURP patients [65.7 (34.2; 10-200) vs 56.6 (23.3; 22-124
) ml; p=0.03]. Likewise, weight of prostate resected was 67.2 (42.8; 6-207) vs 20.23 (15.7; 1-107) mL,
respectively in HoLEP vs TURP patients (p0.05). PSA values significantly decreased both after HoLEP [3.8
(3.3) vs 1.2 (0.8) ng/mL; p<0.05).
Discussion
As reported in literature TURP and HoLEP have good and comparable efficacy on LUTS caused by bladder
outlet obstruction associated with BPH. Considering PSA changes after surgery we found significant
differences between groups.
Conclusions
PSA values significantly decreased both after HoLEP and TURP at long-term FU. At inter-groups difference
analysis PSA values were significantly lower in HoLEP than in TURP patients.
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ONE DAY SURGERY IN THE TREATMENT OF BENIGN PROSTATIC ENLARGEMENT WITH
THULIUM LASER: A SINGLE INSTITUTION EXPERIENCE
SEXUAL OUTCOME OF PATIENTS UNDERGOING THULIUM LASER ENUCLEATION
(THULEP) FOR BPH: FIRST STUDY OF 110 PATIENTS
S. Maruccia, S. Picozzi, E. Finkelberg, C. Marenghi, G. Bozzini, B. Osmolovskiy, A. Kamalov, L.
Carmignani (Milano)
L. Carmignani, G. Bozzini, A. Macchi, S. Picozzi, S. Maruccia, C. Marenghi, S. Casellato, B. Osmolovskiy,
A. Kamalov (Milano)
Aim of the study
Recently, different papers deal with the introduction of new surgical laser therapy for enlarge prostate
gland causing obstructive symptoms. The objective of this study was to report the feasibility of performing
in a one day surgery the endoscopic surgical treatments for benign prostatic obstruction with the ThuLEP
procedure.
Aim of the study
To assess the effect of ThuLEP on sexual function in a group of patients with LUTS secondary to BPH. To
assess whether ThuLEP has any effect on retrograde ejaculation reduction.
A cooperation between the University of Milan and Moscow was settled. From September 2011 to
September 2013 we start a prospective study on patients who underwent ThuLEP in a one day surgery
(a “one day surgery” procedure is considered as a procedure which request at least one night of
hospitalization”). Perioperatively the primary outcomes measured included operative time, resected tissue
weight, hemoglobin decrease, transfusion rate, postoperative irrigation and catheterization time, and
postoperative hospital stay. Also the preoperatory and post-operatory IPSS score and an uroflowmetry
performed at the 7TH and 30TH post-operatory days were recorded. All perioperative and postoperative
complications were monitored.
Results
53 patients performed the surgical treatment in one day surgery. Seven patients continued anti-aggregant
therapy with aspirin. Mean preoperative prostatic adenoma volume was 56.6 mL. Mean operative time
was 71 min. The average catheter-time was respectively of 14.8 hours. The 7th day peak urinary flow rate
improved from 9.3 to 17.42 ml/s (P < 0.001) and IPSS from 18 to 10,2 (P < 0.01). Patients were routinely
discharged the same day of catheter removal. Complications were not recorded.
Discussion
This strategy results cost saving. ThuLEP shows a good standard outcomes considering flow parameters
improvement, length of bladder catheterization.
A cooperation between the University of Milan and Moscow was settled. Prospective study that analyzes
changes in sexual function and urinary symptoms in a group of 110 consecutive patients that underwent
ThuLEP. To assess the changes on erection and ejaculation, urinary symptoms and their interference on
quality of life, four validated questionnaires were used: MSHQ-EjD, ICIQ-MLUTSsex, AUA questionnaire
and QoL index of the ICC. Patients were evaluated before surgery and 3 and 6 months after ThuLEP.
Patients with previous abdominal surgery were excluded. Statistical analysis was performed by the Student
t and chi-square Test and logistic regression analysis. For all statistical comparisons significance was
considered at p<0.05.
Results
Mean age was 67.83 years. The table show the changes in scores on the questionnaires employed. No
significant differences were observed between the number of patients about erectile function before and after
surgery. The percentage of patients with conserved ejaculation increased with ThuLEP to 52.7%.
Discussion
ThuLEP causes an improvement in the scores of questionnaires that assess urinary symptoms and the
interference of the symptoms in the quality of life of patients.
Conclusions
Although endoscopic management of BPH (TURP and new technologies) causes most of patients have
retrograde ejaculation, in patients who underwent ThuLEP there is a conserved ejaculation.
Conclusions
ThuLEP can be conducted safely as a one day surgery procedure.
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SHORT-TERM TREATMENT WITH DUTASTERIDE BEFORE BIPOLAR TRANSURETHRAL
RESECTION OF THE PROSTATE (B-TURP) CAN REDUCE INTRAOPERATIVE BLEEDING
IN LARGE PROSTATE: EVALUATION OF VASCULAR ENDOTHELIAL GROWTH FACTOR
(VEGF) AND CD34.
SURGICAL MANAGEMENT OF BPH: CURRENT PRACTICE PATTERNS AND ATTITUDES IN
EUROPE
R. Giovannone, G. Busetto, G. Antonini, V. Gentile, E. De Berardinis (Roma)
Aim of the study
Dutasteride is an antiandrogen that inhibits 5-α-reductase, an enzyme that converts testosterone to
dihydrotestosterone. Dutasteride significantly reduces intraoperative bleeding when 0.5 mg/d is administered
for 60 days before transurethral resection of the prostate.
Our double-blind, randomized, placebo-controlled study evaluated 300 patients with benign prostatic
hyperplasia who underwent transurethral resection of the prostate. We compared a placebo group (n =
150) with a group (n = 150) administered 0.5 mg of dutasteride once a day for 8 weeks. We intended to
demonstrate the mechanisms and effects of dutasteride compared with those of vascular endothelial growth
factor, and to evaluate CD34, an immunohistochemical marker of blood vessel density in the prostate.
Results
In 8 weeks, 0.5 mg/d of dutasteride reduced serum DHT by 95%, with intraprostatic DHT about 27
times lower than in the placebo group. A difference in perioperative bleeding was observed between the
dutasteride group (1.4– 1.6 g Hb resected) and the placebo group (2.1–2.5 g Hb resected). Average MVD of
the hypertrophic prostate, calculated by CD34 evaluation, was lower in patients treated with dutasteride than
placebo. The average VEGF index of the hypertrophic prostate was lower in patients treated with finasteride
(1.87 ± 0.39) than placebo (4.05 ± 0.80).
Discussion
Our study used VEGF and CD34 antibodies, starting from preclinical study in rats, to determine microvessel
density in patients with BPH. We intending to demonstrate a correlation between dutasteride action and the
vascularization of hypertrophic prostate tissue. We clearly demonstrated that VEGF and CD34 values were
firmly lower in patients pretreated with dutasteride than placebo; therefore, a correlation exists.
Conclusions
Dutasteride reduces intraoperative B-TURP bleeding, as demonstrated by MVD reduction in hypertrophic
prostatic tissue.
C. De Nunzio, R. Sosnowski, N. Thiruchelvam, S. Ahyai, R. Autorino, A. Bachmann, A. Briganti, G. Novara
(Roma)
Aim of the study
Management of Benign Prostatic Hyperplasia (BPH) related Lower Urinary Tract Symptoms (LUTS) is
variable throughout Europe. The aim of the present survey was to evaluate the current practice patterns and
attitudes of urologists across Europe in the management of BPH/LUTS.
A purpose-built questionnaire (28 questions) was developed by the Young Academic Urologist BPH group
and distributed via a free online tool (Survey Monkey) using the monthly EAU Newsletter (received by
2000 EAU members). The questionnaire included 5 questions on the urological setting; 7 questions on
diagnosis and medical management, and 16 questions on surgical management of BPH/LUTS.
Results
637 urologists replied. 77% were younger than 50 years. 44% worked in Academic Hospitals and 17% in
private clinics. 55% reported that 20-50% of their patients have BPH/LUTS. On first presentation, 29%
of those are treatment-naïve. 74% of all urologists considered history taking, IPSS, uroflowmetry, PVR
measurement and PSA testing mandatory prior to any surgical intervention. In the majority (79%), first line
management was an alpha-blocker and second line the addition of a 5-alpha reductase inhibitor (49%). No
response (65%) to or progression (71%) on medical treatment and urinary retention (66%) were the most
important indications for surgical treatment. 93% uses prophylactic antibiotics for surgery. Safety was
deemed the major advantage of laser prostatectomy (39%) with cost as the major disadvantage (57%). 43%
have experience in performing laser prostatectomy and considered the best laser treatment: Holmium:YAG
(44%) , KTP:YAG (24% ), Thulium:YAG (18% ), and others (13%). Efficacy of surgical treatment was
measured most frequently by IPSS (80%), uroflowmetry (80%) and PVR (68%). UTI (12%) and dysuria
(26%) were the most common short-term complications, and UTI (9%) and retrograde ejaculation (67%)
the most common long-term complications. 7% of all surgically treated patients required re-treatment with
secondary TURP (86%), urethrotomy (79%) or bladder neck incision (77%).
Discussion
Most urologists recommend medical alpha-blocker therapy as first-line treatment. The most popular surgical
procedure remains TURP. Open prostatectomy still has an established role. Laser procedures are used by a
significant but still minor group of practising urologists. Importantly, the EAU members asked seem mostly
to investigate and treat male LUTS patients in concordance with current EAU guidelines.
Conclusions
This survey provides a description of how European urologists diagnose and manage BPH/LUTS.
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THULIUM VAPORESECTION OF THE PROSTATE (THUVARP) AND THULIUM
VAPOENUCLEATION OF THE PROSTATE (THUVEP) IN PATIENTS ON ANTICOAGULANT
THERAPY: A RETROSPECTIVE THREE- CENTRE MATCHED-PAIRED COMPARISON WITH
SHORT-TERM FOLLOW-UP
TRANSURETHRAL THULIUM LASER VAPO-ENUCLEATION VERSUS TRANSVESICAL
OPEN ENUCLEATION FOR PROSTATE ADENOMA GREATER THAN 80 G: A STUDY OF 78
PATIENTS
C. Netsch, S. Butticè, L. Macchione, T. Herrmann, G. Mucciardi, A. Inferrera, A. Gross, C. Magno
(Hamburg, Germany)
Aim of the study
To evaluate the short-tern clinical efficacy and the complication rates of ThuVEP and ThuVARP in patients
with benign prostatic obstruction (BPO) on ongoing oral anticoagulants (OA).
A three-centre retrospective matched-paired comparison of patients who were cither treated by ThuVEP
(n=26) or ThuVARP (n=26) according to prostate size was performed. Thirty-four patients were on aspirin/
ticlopidin, 7 on clopidogrel or clopidogrel and aspirin, and 11 on phenprocoumon/warfarin at time of
surgery. Data were compared for perioperative variables, functional outcome, and complications.
Results
Median prostate volume (62,5 vs. 63,5ml) and resectcd weight (43 vs. 42.5 g) diffcrcd not significantly
bctween ThuVEP and ThuVARP. The median operation time was significantly higher for ThuVEP compared
10 ThuVARP (72 vs. 46 min, p ≤ 0.031). Hb decrease was significantly higher for ThuVEP compared to
ThuVARP (1 .5 vs. 0.3 g/dl, p
Discussion
Currently, a variety of laser therapies are available for prostate surgery to treat BPO and have good results;
ThuVEP and ThuVARP have had good results, even in high-risk patients or patients with large prostatic
adenomas . ThuVaRP was introduced recently for the treatment of BPO and has been shown to be safe and
effective in men with small- and medium-sized prostates. Wider application of ThuVaRP, to larger prostates,
is limited, owing to the prolonged operation time that would be required for this procedure. ThuVEP was
developed to solve this problem. ThuVEP is based upon the HoLEP technique, in which the entirety of the
median and lateral lobes are anatomically dissected from the surgical pseudocapsule using a retrograde
approach and are mechanically morcellated in the bladder. In our study, although the teciniche ablation are
different, have proved to be both safe in the treatment of patients with BPO treated with OA
G. Bozzini, S. Picozzi, A. Macchi, D. Ratti, C. Marenghi, B. Osmolovskiy, A. Kamalov, L. Carmignani
(Milano)
Aim of the study
Prostate adenomas greater than 80 ml have traditionally been treated with open prostatectomy or
transurethral resection by skilled resectionists. This procedure may involve considerable blood loss,
morbidity, prolonged hospital stay and recovery time. We compare transurethral Thulium laser enucleation
(ThuLEP) of the prostate to open prostatectomy for the surgical management of large prostate adenomas.
A cooperation between the University of Milan and Moscow was settled. A total of 78 obstructed patients
with a prostate larger than 80 ml on transrectal ultrasound undergo ThuLEP or open prostatectomy. All
patients were assessed preoperatively and postoperatively. Patient baseline characteristics, perioperative data
and postoperative outcome were compared. All complications were noted.
Results
48 patients undergo to ThuLep and 30 to open prostatectomy. Mean patient age is 78 in the ThuLep group
and 72 in the open adenomectomy group. Mean preoperatory transrectal adenoma volume is 126 ml and 115
ml respectively. Mean Hemoglobin loss was significantly less (p
Discussion
ThuLep and open prostatectomy are equally effective procedures for removal of large prostatic adenomas.
Conclusions
ThuLep resulted in significantly less perioperative morbidity and may become the endourological alternative
to open prostatectomy.
Conclusions
ThuVEP and ThuVARP are both safe and efficacious procedures for patients with symptomatic BPO on
OA. Although patients assigned for ThuVEP had higher Qmax at 6- month follow up, ThuVARP resulted in
similar functional outcome (lPSS, QoL, PVR) and re-operation rates. Further follow-up is needed to draw
final conclusions about the long-term efficacy of ThuVARP
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AUTOIMMUNE DISEASES ARE HIGHLY COMORBID IN PATIENTS WITH PEYRONIE’S
DISEASE – RESULTS OF A CROSS-SECTIONAL REAL LIFE STUDY AMONG CAUCASIANEUROPEAN MEN
CHARACTERISTICS OF SECONDARY, PRIMARY, AND COMPENSATED HYPOGONADISM
IN CAUCASIAN-EUROPEAN MEN PRESENTING FOR PRIMARY COUPLE’S INFERTILITY –
RESULTS OF A CROSS-SECTIONAL SURVEY
E. Ventimiglia, M. Colicchia, P. Capogrosso, A. Serino, L. Boeri, G. Castagna, A. Pecoraro, G. La Croce, R.
Damiano, A. Briganti, F. Montorsi, A. Salonia (Milano)
G. Castagna, M. Colicchia, E. Ventimiglia, L. Boeri, A. Serino, P. Capogrosso, A. Pecoraro, M. Paciotti, A.
Russo, F. Cantiello, R. Damiano, A. Briganti, F. Montorsi, A. Salonia (Milano)
Aim of the study
We sought to investigate autoimmune diseases’ prevalence in a cohort of patients seeking medical help for
sexual dysfunction, focusing on those complaining of Peyronie’s disease (PD).
Aim of the study
Investigate whether different forms of hypogonadism can be distinguished among Caucasian-European men
presenting for primary couple’s infertility.
Complete sociodemographic and clinical data from 1140 consecutive patients presenting for new-onset
sexual dysfunction (Jan 2010 – June 2013) were analysed. Health-significant comorbidities were scored with
the Charlson Comorbidity Index (CCI) as a continuous or a categorized variable (0 vs 1 vs ≥2). Categorized
measured body mass index (BMI) cut-offs were used as proposed by the NIH. All patients completed the
International Index of Erectile Function (IIEF) domains. Autoimmune diseases were assessed through a
comprehensive history examination and stratified according to ICD-9 classification.
Complete demographic, clinical and laboratory data from 965 consecutive infertile men were analyzed. Four
groups of individuals were defined: eugonadal [normal testosterone (T ≥ 3.03 ng/mL) and normal LH (≤9.4
mUI/mL)], secondary (low T and low/normal LH), primary (low T and elevated LH), and compensated
(normal T and elevated LH) hypogonadism. Health-significant comorbidities were scored with the
Charlson Comorbidity Index (CCI; categorized 0 vs 1 vs ≥2). Testicular volume was assessed with a Prader
orchidometer. Semen analysis values were assessed based on 2010 World Health Organization reference
criteria. Descriptive statistics detailed the association between semen parameters and clinical characteristics
and the defined gonadal status.
Results
Of 1140, ED and PD were diagnosed in 665 (58.3%) and in 148 (13%) men, respectively. Of all, 34 (3%)
patients had a confirmed diagnosis of autoimmune disease. Among PD patients, 14 (9.5%) presented with
an autoimmune disorder; conversely, non-PD patients did present an autoimmune disease in a significantly
lesser amount of cases [20/992 (2%); χ2: 24.7; p
Discussion
Inflammation and immune system are known to be involved in PD pathogenesis. Approximately 75% of PD
patients have positive immunologic test and 38% displaying autoantibodies, whereas several author report
consistent association between PD and specific HLA subtypes. The association found in our study seems
consistent with these data, hinting an inappropriate role of the immune system in PD onset and development.
Conclusions
Autoimmune diseases emerge as highly comorbid with PD in a large cohort of individuals seeking medical
help for sexual dysfunction in the real life setting.
Results
Of all, eugonadism, secondary, primary, and compensated hypogonadism were found in 757 (78.4%),
111 (11.5%), 27 (2.8%), and 70 (7.3%) men, respectively. Health status [defined as for CCI (Chi2: 18.7;
p=0.005), prevalence of hypertension (Chi2: 19.7; p
Discussion
Male endocrine assessment is of fundamental importance during evaluation of the infertile couple: 30% to
70% of men with male infertility show some degree of concurrent endocrine dysfunction even if primary
hormonal cause is found in less than 3% of infertile men. This study has been carried out to check the
prevalence of different hypogonadism forms in a Caucasian-European cohort of men presenting for primary
couple’s infertility and to assess correlations between hypogonadism status and clinical characteristics of
infertile men.
Conclusions
Overall, the prevalence of hypogonadism was 21.6% within our cohort of Caucasian-European men
presenting for primary couple’s infertility. Clinical, endocrine and seminal characteristics significantly
worsen according to the defined gonadal status.
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DETERMINANTS OF SEXUAL DYSFUNCTION AND SEXUAL QUALITY OF LIFE IN MEN
WITH MULTIPLE SCLEROSIS
EFFECTS OF SILODOSIN ON SEXUAL FUNCTION – REALISTIC PICTURE FROM THE
EVERYDAY CLINICAL PRACTICE
R. Balsamo, C. Di Palma, A. Izzo, M. Grillo, M. Stizzo, R. Autorino, M. De Sio (Napoli)
M. Colicchia, P. Capogrosso, A. Serino, L. Boeri, E. Ventimiglia, G. Castagna, M. Paciotti, G. La Croce, A.
Pecoraro, F. Cantiello, R. Damiano, A. Briganti, F. Montorsi, A. Salonia (Milano)
Aim of the study
To find the prevalence of sexual dysfunction in male patients with multiple sclerosis and to determine
disease-related and psychological risk factors for sexual dysfunction in these patients
From September 2013 to February 2014, 50 consecutive male patients with multiple sclerosis were recruited
from our neurological department. The following questionnaires were administered: the International Index
of Erectile Function(IIEF) to evaluate sexual function, the Sexual Quality of Life Questionnaire –Male
Version(SQoL-M) to evaluate the sexual quality of life. The presence of voiding dysfunction was evaluated
by the International prostate symptom score(I-PSS). In addition neurological impairment was measured
using the Kurtzke Expanded Disability Status Scale (EDSS) and depression was assessed using the Beck
Depression Inventory-II (BDI-II).
Results
Of the 50 male patients studied, mean age 40 years (20-64), 30 (60%) met the criteria for sexual dysfunction.
The most common complaints were erectile dysfunction (53%), decreased sexual desire (27%) and
difficulties in reaching orgasm (23.1%) or ejaculation (18%). The severity of SD had a clear impact on
sexual quality of life, especially in the domains of erectile function and intercourse satisfaction. The results
obtained from multiple logistic regression analysis indicated that the disease duration (P = 0.01), the disease
course (secondary progressive P = 0.004) and the BDI score (P < 0.001) were significant factors contributing
to sexual dysfunction in these patients
Discussion
MS usually occurs when people would be expected to be in the prime of their sexual and reproductive
life. MS leads to a significant deterioration in sexual lives of men. The findings from this study indicated
that the duration and severity of the disease in addition to depression were the most significant factors that
contributed to sexual dysfunction in man with multiple sclerosis. The data support a multifactorial etiology
of SD in MS.
Conclusions
SD in MS is a complex set of conditions, associated with anatomic, physiologic, biologic, medical and
psychological factors. SD is highly prevalent but commonly overlooked in MS patients and has a significant
impact on their sexual quality of life. More focus on SD and use of appropriate screening tools in clinical
practise with MS patients are recommended
260
Aim of the study
We sought to determine the effects of silodosin 8 mg, a highly selective once-daily dosing α1-adrenoceptor
blocker, on sexual function, including ejaculation and orgasm, sexual desire, and erectile function, in
sexually active men with lower urinary tract symptoms (LUTS) suggestive of BPH (LUTS/BPH) in the
everyday clinical practice.
Sociodemographic and clinical data from 137 consecutive patients treated with silodosin 8 mg for LUTS/
BPH were analysed. Patients were interviewed about potential treatment-emergent adverse events (TEAEs)
as taken from the patient information leaflet of silodosin, along with some specific questions regarding
sexual functioning. Moreover, all patients filled in the International Prostate Symptom Score (IPSS) at
baseline and at the time of survey. Likewise, patients completed a remembered International Index of
Erectile Function (IIEF)-Orgasmic Function (OF) domain (IIEF-Q9 [ejaculatory frequency] and Q10
[orgasmic frequency]), which targeted sexual function regarding a period preceding the treatment with
silodosin and a real-time IIEF-OF, targeting the 4 weeks prior to the survey. Descriptive statistics and
logistic regression models tested the association between sexual function and potential predictors.
Results
Of all, 22 (16.1%) and 15 (10.9%) individuals refused to participate to the survey and did not even start
silodosin, respectively. Complete data were available for 100 patients [mean (SD) age: 63.2 (12) yrs; range
44-77]. At survey, silodosin resulted highly effective in improving IPSS total [16.3 (7.5) vs 10.7 (6.4); p
Discussion
We demonstrated how silodosin is effective in treating LUTS in a real-life setting as shown by IPSS score
improvement. These data confirm what previously reported by other authors. The reported rate of ejaculation
disorder was also about 70%; interestingly this real-life rate is slightly lower than what reported by several
studies on sexual active men affected by BPH/LUTS.
Conclusions
Silodosin is a highly effective treatment for patients with LUTS/BPH. Of them, roughly 70% report
anejaculation or hypospermia. A more or less severe OF impairment is recorded in 17% of the cases.
Anejaculation is the cause of silodosin drop-off in only 6% of the patients.
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FUNZIONE ERETTILE NEI PAZIENTI CON IPOSPADIA FALLITA
LA SALUTE DEGLI ADOLESCENTI COSA CONOSCIAMO?
V. Iacovelli, G. Barbagli, G. Vespasiani, L. Topazio, C. Gonzalez, S. Sansalone (Roma)
G. BENEDETTO, G. ABATANGELO, F. NIGRO, E. SCREMIN , I. SPANO , A. TASCA (VICENZA)
Scopo del lavoro
Sebbene siano presenti in letteratura diversi studi sulla funzione erettile in pazienti con stenosi uretrali,
molto rari sono i lavori che analizzano la funzione erettile e il trattamento dell’ipospadia fallita. A tal
proposito, il nostro studio è volto a valutare la funzionalità erettile in pazienti sottoposti ad uretroplastica per
ipospadia fallita.
Scopo del lavoro
la salute degli adolescenti come l’educazione riveste un ruolo importante nella società.Gli interventi di
educazione alla salute nelle scuole mirano a conoscere lo stato di salute dei ragazzi e prevenire le patologie
andrologiche adolescenziali.
Materiali e metodi
In maniera retrospettiva sono stati analizzati i dati di 163 pazienti adulti con una storia di riparazione
fallita di ipospadia e trattati con uretroplastica in due centri (Italia e USA). Tutti i pazienti hanno compilato
l’IIEF-6 prima dell’intervento. Le categorie classiche di interpretazione della disfunzione erettile (ED)
secondo l’IIEF-6 sono state applicate, considerando: nessuna ED (≥26), minima (18-25), moderata (11-17),
severa (≤10).
Risultati
L’età media dei pazienti sottoposti a uretroplastica è stata 39.7 anni. Basandoci sull’IIEF-6, il 54% dei
pazienti si presentava con ED; il 22.1% con ED severa, il 3.7% con ED moderata e il 28.2% con ED lieve.
Mentre la popolazione più adulta (>50 anni) ha registrato la più alta incidenza di ED severa (38.9%), la
popolazione più giovane (≤30 anni) registrava un 60% di disfunzione erettile di cui il 18% classificata come
severa.
Discussione
Il lavoro dimostra una chiara correlazione tra trattamento fallito per ipospadia, età avanzata e ED; esiste una
proporzione inversa tra comparsa di ED e numero di reinterventi per ipospadia.
Conclusioni
Spesso, dopo riparazioni fallite di ipospadia i pazienti richiedono una ricostruzione complessa dell’uretra
che implica degli effetti deleteri sia a livello urinario sia a livello della qualità della vita sessuale. Tra questi
pazienti compare sovente una ED baseline. I pazienti con età superiore ai 50 anni hanno un’incidenza
maggiore di ED severa; tuttavia, molti dei pazienti più giovani si presentano con un certo grado di ED di cui
buona parte di severa entità. L’intervento di uretroplastica non sembra influire negativamente sulla funzione
erettile in pazienti con pregressa riparazione di ipospadia; un questionario specifico sarebbe necessario per
inquadrare meglio l’argomento.
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Materiali e metodi
nell’anno scolastico 2013-2014 il nostro corso ha coinvolto 8 scuole superiori della città (studenti coinvolti
1150,età media 17 anni,classi III).Il corso è iniziato con la somministrazione da parte degli insegnanti di un
questionario anonimo,elaborato con la Facoltà di Sociologia,formato da 20 items che valutavano lo stato di
salute del ragazzo,le abitudini,le conoscenze delle patologie andrologiche,l’approccio al rapporto sessuale
e le malattie sessualmente trasmesse Successivamente sono state illustrate con slides le principali patologie
andrologiche,infine i ragazzi sono stati sottoposti a visita medica andrologica
Risultati
nelle tabelle sono riassunti i risultati degli items: COME VA IN GENERALE LA TUA SALUTE? Bene
644 (56%) Molto bene 322 (28%) Discretamente 161 (14%) Male 23 (2%) HAI AVUTO QUALCHE
DISTURBO NELL’ULTIMO ANNO? Ansia 299(26%) Angoscia 195(17%) Eiaculazione precoce 70(6%)
Disfunzione erettile 35(3%) Insonnia 195(17%) Depressione 92 (8%) Nulla 264(23%) CON QUALE
FREQUENZA VEDI IL MEDICO CURANTE quando ho bisogno 1127(98%) una o più volte al mese
23 (2%) CON QUALI PERSONE TI CONSIGLI PER L’USO DI FARMACI medico curante 632(55%)
familiari 518(45%) BEVI ALCOLICI ? si 1023(89%) no 127(11%) E’ UTILE PER UN RAGAZZO
UTILIZZARE VIAGRA? No 1092(95%) Non so 58 (5%) USI METODI CONTRACCETTIVI
PRIMA DI UN RAPPORTO? Si 621(54%) No 460(40%) Non ho rapporti 69(6%) CONOSCEVI L’
AUTOPALPAZIONE DEL TESTICOLO? Si 242(21%) No 908(79%)
Discussione
Gli interventi di prevenzione di salute negli adolescenti sono necessari per conoscere le abitudini dei ragazzi
e per attuare campagne di prevenzione. Dal nostro studio un dato preoccupante è che buona parte degli
adolescenti valutati soffre di ansia ed angoscia ed il 16% dei pazienti definisce il suo stato di salute discreto/
male.Il 70% inoltre riferisce disturbi dell’eiaculazione ed il 35%disfunzioni erettive
Conclusioni
La prevenzione delle patologie andrologiche dovrebbe iniziare molto presto con campagne mirate nelle
scuole al fine anche di conoscere il malessere degli adolescenti e poter dare loro delle risposte pratiche nella
fase dello sviluppo
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OUTCOME SESSUALI DOPO PENECTOMIA PARZIALE: ANALISI DEI RISULTATI DI UNO
STUDIO MULTICENTRICO.
PREVALENCE OF AND IMPACT OF HEALTH-SIGNIFICANT COMORBIDITIES IN
CAUCASIAN-EUROPEAN MEN PRESENTING FOR PRIMARY COUPLE’S INFERTILITY –
RESULTS OF A CROSS-SECTIONAL SURVEY
V. Iacovelli, M. Silvani, R. Leonardi, G. Vespasiani, L. Topazio, S. Sansalone (Roma)
Scopo del lavoro
Il tumore del pene è una neoplasia rara. Per gli stadi più avanzati della malattia, l’approccio terapeutico
aggressivo con penectomia totale o parziale rimane il trattamento standard. Il trattamento chirurgico risulta
inevitabilmente mutilante e può condurre ad effetti psico-sessuali devastanti. Pertanto, considerando il forte
impatto sulla vita sessuale, il nostro obiettivo è stato quello di valutare la funzione sessuale, la qualità del
rapporto di coppia e la soddisfazione generale del paziente dopo penectomia parziale.
Materiali e metodi
Nel presente studio sono stati arruolati 25 pazienti con diagnosi di tumore del pene che sono stati studiati
nel periodo compreso tra Ottobre 2011 e Novembre 2013. Tutti i pazienti sono stati sottoposti ad intervento
di penectomia parziale e ricostruzione del glande con flap uretrale. Tutti i pazienti sono stati seguiti
ambulatorialmente durante il follow-up di almeno 12 mesi (range 12-25). La funzione sessuale preoperatoria è stata calcolata tramite l’IIEF-15. Gli outcome sessuali sono stati raccolti per ogni paziente
attraverso l’utilizzo di questionari validati (IIEF-15, EDITS, QEQ, SEAR). I dati sono stati raccolti in
maniera prospettica e analizzati in maniera retrospettiva.
Risultati
La penectomia parziale ha condotto a dei risultati piuttosto uniformi in termini di lunghezza del pene
dopo trattamento chirurgico. La soddisfazione inerente il trattamento è stata valutata dal paziente e dalla
partner tramite l’utilizzo del questionario Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS
questionnaire) con valori pari a 74.97 per il paziente e 73.25 per la partner. L’IIEF-15 è stato analizzato nei
suoi 5 domini; IIEF 1-5,15 con uno score pari a 21.28, IIEF 6-8 pari a 7.32, IIEF 9,10 pari a 7.92, IIEF 13,14
con valore pari a 6.52. Il Quality of Erection Questionnaire (QEQ questionnaire) ha avuto un valore medio
di 77.46. Il Self-Esteem And Relationship (SEAR questionnaire) ha ottenuto i seguenti risultati: SEAR 1-8
pari a 68.06; SEAR 9-12 score di 73.25, SEAR 13-14 pari a 74.5.
Discussione
Nonostante l’importante portata psico-emotiva legata al tumore del pene e ai suoi trattamenti radicali, sono
scarsi i lavori che analizzano gli outcome sessuali dopo tali procedure. Lo studio è stato condotto nell’ordine
di comprendere lo stato emotivo del paziente e i risultati dopo trattamento chirurgico così da poter seguire lo
stesso in maniera globale.
M. Colicchia, E. Ventimiglia, P. Capogrosso, A. Serino, L. Boeri, L. Villa, G. Castagna, A. Russo, F.
Castiglione, G. La Croce, R. Matloob, A. Briganti, R. Damiano, F. Montorsi, A. Salonia (Milano)
Aim of the study
We sought prevalence of, clinical and seminal impact of comorbidities in Caucasian-European men
presenting for primary couple’s infertility.
Complete demographic, clinical and laboratory data from 1435 consecutive infertile men were analysed.
Health-significant comorbidities were scored with the Charlson Comorbidity Index (CCI; categorized 0 vs
1 vs ≥2); NCEP-ATPIII criteria were used to define metabolic syndrome (MetS). Testicular volume was
assessed with a Prader orchidometer. Semen analysis values were assessed based on 2010 World Health
Organization (WHO) reference criteria. Descriptive statistics and logistic regression models tested the
association between semen parameters and clinical characteristics and CCI score.
Results
When assessing general comorbidities prevalence, in 1328 (92.5%) patients no comorbidities (CCI=0) were
found, whereas CCI=1 and CCI≥2 were respectively present in 54 (3.8%) and in 53 (3.7%) men. Patients
with CCI≥2 were older (p=0.004), had a lower left testicular volume (p
Discussion
Male factor infertility has already been shown to account for a higher CCI, which may be considered a
reliable proxy of a lower general health status, regardless of the etiology of pure male infertility. Our results
confirmed this hypothesis and specifically showed a higher age, rate of hypertension, obesity and Mets in
patients with higher CCI as compared with patients without comorbidities (CCI=0). Moreover, a higher
burden of comorbidities seem to detrimentally impact over semen paramaters. This cross-sectional study
underlined the importance of male factor infertility such as a useful tool to predict the impairment of general
health status.
Conclusions
A general lower health status, as assessed with CCI score, in primary infertile men appears to be associated
with a reduced testicular volume, metabolic and hormonal abnormalities, and pathological sperm
progressive motility.
Conclusioni
Il tumore del pene conduce a severe disfunzioni sessuali e psicosessuali. Se trattati in maniera adeguata, i
pazienti sottoposti a penectomia parziale possono mantenere degli outcomes sessuali più che soddisfacenti,
seppur inferiori allo stato antecedente l’intervento chirurgico.
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RELAZIONE TRA DISFUNZIONE ERETTILE, LIVELLI DI TESTOSTERONE E FUNZIONE
ENDOTELIALE IN PAZIENTI A RISCHIO CARDIOVASCOLARE INTERMEDIO SECONDO LE
STIME DELLA CARTA DI FRAMINGHAM
THE INFLUENCE OF METABOLIC SYNDROME AND PHYSICAL ACTIVITY ON ERECTILE
AND EJACULATORY DYSFUNCTION IN PATIENTS WITH LOWER URINARY TRACT
SYMPTOMS
C. Pavone, R. Iacona, V. Bonomo, V. Evola, M. Di Piazza, E. Corrado, G. Novo, S. Novo (Palermo)
R. Lombardo, C. De Nunzio, F. Presicce, M. Leo, F. Esperto, F. Cancrini, A. Borghese, A. Tubaro (Roma)
Scopo del lavoro
Il ruolo dei livelli di testosterone plasmatico e della disfunzione erettile come marcatori precoci di
disfunzione endoteliale non è ben definito. Pertanto, abbiamo cercato di analizzare la relazione tra
testosterone plasmatico e disfunzione erettile, in rapporto alla funzione endoteliale.
Aim of the study
A possible relationship between metabolic syndrome (MetS) and erectile dysfunction has been investigated.
However no studies evaluated the influence of MetS, physical activity on erectile and ejaculatory
dysfunction. Aim of our study was to evaluate the association between MetS/physical activity and erectile/
ejaculatory dysfunction in patients with lower urinary tract symptoms
Materiali e metodi
Abbiamo quindi arruolato 802 pazienti in prevenzione primaria, con una stima di rischio cardiovascolare
(CV) intermedio secondo la carta del rischio di Framingham, di età compresa fra 40 e 80 anni, che si sono
sottoposti all’esame ecografico della dilatazione flusso mediata dell’arteria brachiale destra, alla valutazione
della disfunzione erettile attraverso il questionario International index of erectile function-5 score (IIEF-5) ,
e al dosaggio dei livelli plasmatici di testosterone totale.
Risultati
All’analisi di regressione lineare, con l’aumentare dei livelli di testosterone, aumentavano in maniera
statisticamente significativa sia la funzione endoteliale (t=9.40; 95% CI da 0.9318 a 1.4234; p < 0.0001)
che la funzione erettile (t=8.96; 95% CI da 0.7642 a 1.1932; p< 0,001) sia con la disfunzione erettile severa
(OR 0,78; CI 0,62 -0,86), e moderata (OR 0,85; CI 0,72 - 0,97) che con una peggiore funzione endoteliale
[(OR 0,68; CI 0,59- 0,79) e (OR 0,76; CI 0,63 - 0,83) rispettivamente]. Invece, le forme più sfumate di
disfunzione erettile come quella lieve (OR 0.94; CI 0.82 - 1.07; p=0.03) e lieve-moderata (OR 0,8; CI 0,69 0,94; p
From 2012 onwards, a consecutive series of men with lower urinary tract symptoms evaluated with the
International Prostatic symptom score (IPSS) were enrolled into a prospective database. All patients were
evaluated for erectile and ejaculatory dysfunction using the short form of the International Index of Erectile
Function (IIEF) and the male sexual health questionnaire ejaculatory dysfunction short form (MSHQ).
Body mass index (BMI) and waist circumferences were measured; blood samples were collected and
tested for: total PSA, glycemia, HDL, trygliceridemia, testosterone levels. Blood pressure was recorded.
Metabolic syndrome (MetS) was defined according to the Adult Treatment panel III. Physical activity scale
questionnaire (PASE) was collected in all the patients.
Discussione
Abbiamo quindi dimostrato una correlazione significativa tra livelli più bassi di testosterone plasmatico
totale, disfunzione erettile ed una peggiore funzione endoteliale in una popolazione di soggetti asintomatici
e a rischio CV intermedio. In particolar modo, nel sottogruppo di pazienti con disfunzione erettile moderatasevera, abbiamo visto che coloro che hanno livelli più bassi di testosterone hanno anche delle percentuali di
dilatazione flusso mediata inferiori, e quindi una peggiore funzione endoteliale.
Results
191 patients were enrolled with a mean age and PSA of 68±7 years and 5.1± 2 ng/ml respectively. Mean
BMI was 26±3.6 kg/m2 ; mean waist circumference was 103±8.5 cm; mean IPSS was 11.2±7; mean IIEF
was 15.2±9; mean MSHQ was 8.9±6, mean PASE was 103±73 and mean testosterone serum level was
3.9±1.4 ng/ml.57 pts (29.8%) presented a MetS. Patients with MetS presented a lower IIEF (12±9.6 vs
16±9; p= 0.013), PASE (92±76 vs 108±71; p= 0.045) and testosterone serum levels (3.4±1.4 vs 4±1.4;
p=0.36) while no difference was observed for IPSS (11±8 vs 10±6; p= 0.279) and MSHQ (8±6 vs 9±6;
p= 0.173). A moderate/severe erectile dysfunction was observed in 78 (40%). In 33/57 (58%) of pts with
MetS we observed a moderate severe erectile dysfunction (p=0.002).On multivariate analysis MetS (OR:
2.180, 95%CI: 1.045-4.593; p= 0.038) and Age (1.121 per year 95%CI: 1.067-1.178, p= 0.00) were the only
independent risk factor for severe/moderate erectile dysfunction.
Conclusioni
Sulla base di questi risultati, consigliamo la valutazione della disfunzione erettile attraverso l’IIEF-5, e il
dosaggio dei livelli di testosterone totale plasmatico, per ottenere una stratificazione più accurata del rischio
CV nei pazienti asintomatici, ma con rischio intermedio secondo le stime della carta di Framingham.
Discussion
In our single center study, MetS was associated with a reduced physical activity, a lower serum testosterone
level and an higher risk of erectile dysfunction. In our experience MetS has no influence on the ejaculatory
dysfunction evaluated with the MSHQ.
Conclusions
Even though the molecular pathways are yet to be understood, it is important to consider MetS and the
associated metabolic abnormalities as important factors to consider in the management of men’ health.
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VALORI PREDITTIVI DI DISFUNZIONE ERETTILE IN PAZIENTI SOTTOPOSTI A PRIMA
VISITA UROLOGICA: VALIDAZIONE DI UNA NUOVA STRATIFICAZIONE DEL RISCHIO
COLLINS LOOP EN BLOC RESECTION( CLEBR) FOR ACCURATE STAGING OF PRIMARY
NON MUSCLE INVASIVE BLADDER CANCER: EARLY EXPERIENCE
V. Favilla, G. Russo, S. Privitera, E. Fragalà, S. Leone, G. Reale, T. Castelli, S. Cimino, G. Morgia (Catania)
R. Hurle, R. Hurle, L. Castaldo, M. Seveso, G. Taverna, P. Luisa, S. Zandegiacomo De Zorzi, A. Benetti, P.
Graziotti (Rozzano)
Scopo del lavoro
La disfunzione erettile (DE) sta progressivamente emergendo come un’importante indicatore generale della
salute maschile e si associa frequentemente ai sintomi del basso tratto urinario (LUTS). Scopo dello studio è
verificare se la gravità dei LUTS, associata alla presenza di comorbidità, si associ ad un aumentato rischio di
avere DE. Abbiamo sviluppato, quindi, una stratificazione di rischio multivariata con lo scopo di stabilire il
rischio di manifestare DE in pazienti sessualmente attivi alla prima visita urologica.
Materiali e metodi
Tra il gennaio 2009 e dicembre 2013 sono stati arruolati 425 pazienti consecutivi con normale attività
sessuale e normali valori di testosterone sierico; è stata indagata la funzione sessuale e i LUTS mediante
l’uso di questionari validati (IIEF-5 ed IPSS) e le comorbidità mediante il Charlson Comorbidity Index
(CCI). E’ stata eseguita la regressione logistica univariata con lo scopo di identificare i fattori di rischio di
disfunzione erettile. Tutti i fattori di rischio indipendenti di DE sono stati combinati in quattro differenti
classi di rischio: bassa (età ≤65 anni, IPSS 65 anni, IPSS ≥8 o CCI ≥1), alta (presenza di due tra i seguenti
fattori di rischio: età >65, IPSS ≥8 o CCI ≥1), molto alta (età >65 anni e IPSS ≥8 e CCI≥1).
Risultati
La prevalenza della disfunzione erettile aumenta con l’aumentare delle comorbidità valutate tramite CCI (χ2
ratio: 40.85, p=0.001); il punteggio medio dell’IIEF-5 si riduce in maniera significativa con l’aumentare del
CCI (p
Discussione
Diversi fattori di rischio sono stati associati alla presenza di DE. L’utilizzo della nostra stratificazione del
rischio può essere utile per rivelare la presenza di DE in pazienti sottoposti a prima visita urologica.
Conclusioni
L’età, le comorbidità ed i LUTS sono associati in maniera significativa al peggioramento della disfunzione
erettile; la combinazione, quindi, di questi fattori tramite la stratificazione del rischio può essere un valido
strumento per determinare i pazienti con disfunzione erettile non ancora manifesta.
Scopo del lavoro
A primary aim of transurethral resection of bladder tumors is to determine the depth of invasion or clinical
stage.Transurethral resection is a stochastic procedure subject to variations in tumor type,surgical technique
and pathological evaluation.Exact pathological staging of bladder cancer is crucial for determination of
further treatment.One limiting factor is the surgical‘incise and scatter’technique that might contribute
to tumour recurrence.We present initial results with using a Collins loop(with a cutting current)en bloc
resection(CLebR)of bladder tumours for treatment and accurate staging of solitary transitional cell
carcinoma of the bladder.
Materiali e metodi
April 2011-February 2013,67 patients(48 male–19 female) with non muscle-invasive bladder
cancer(NMIBC)underwent transurethral en bloc resection using a Collins Loop.Tumor size ranged to 0.545 mm and multifocality was present in 6% of cases.En bloc resection was applied on all of the tumours.
On 59 of the 67 patients,a re-resection was performed after 6 weeks.The bladder wall is incised around the
lesion using a Collins loop,starting from apparently‘normal’mucosa surrounding the base and then extending
through the subepithelial connective tissue, muscularis mucosae and muscularis propria strata.The resected
1-piece specimen was grasped with a loop electrode and retrieved. After bladder tumor resection the resected
base was observed carefully to assess perforation and bleeding.When the tumor size was greater than 3
cm,excision of the lesion could be easily achieved by mean of a resectoscope with a 5 mm working channel.
After resection, the lesion is grasped with the forceps and retrieved with the resectoscope.All cases of highrisk NMIBC underwent second-look after 30-45 days.
Risultati
Pathology reported urothelial carcinoma with low grade stage Ta, T1 high –grade and T2 high-grade
respectively in 38 ( 56,7% ), 23 ( 34,3% ), 6 ( 8,9% ). All of the resected specimens provided detrusor
muscle, No uncontrollable bleeding, perforation or other serious complications were observed. To date, with
a mean follow up of 16.5 months, the recurrence rate in patients with NMIBC is 13.5%.
Discussione
CLebR has been proven safe and effective for both,treatment and pathological staging of NMIBC;therefore
could be an appropriate tool for accurate staging with possibly lower scattering potential for the assessment
and treatment of patients with NMIBC.
Conclusioni
The objective advantage of accurate pathological examination(identification of microfocal invasion of
lamina propria or of muscular wall,surgical margins assessment) is associated with a substantial safe
technique.Long term data and larger dataset of cases are necessary to demonstrate an advantage in terms of
recurrence or progression.
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CONTRAST-ENHANCED ULTRASOUND (CEUS) IN DETECTION AND EVALUATION OF
BLADDER CARCINOMAS: PRELIMINARY DATA
DOES NBI BIPOLAR TURBT IMPROVE DETECTION RATE AFTER WL TURB?
PRELIMINARY EXPERIENCE IN A SINGLE CENTRE.
AIM
The aim of the study is to evaluate the efficacy contrast-enhanced ultrasound (CEUS) in differentiating low
and high-grade bladder carcinomas and in evaluation of detrusor muscle invasion
F. Pisanti, R. Giulianelli, L. Albanesi, F. Attisani, B. Gentile, D. Granata, L. Mavilla, G. Mirabile, M.
Schettini, G. Vincenti (Roma)
We prospectively evaluated with CEUS 82 patients with cystoscopically-detected bladder tumors. Lesions were
first scanned with a gray-scale ultrasonography (GS-US) and color Doppler ; thereafter, contrast enhanced agent
was injected. A quantitative analysis of enhancement was performed using a dedicated software (QONTRAST)
which elaborates colorimetric maps and process Time/Intensity (T/IS) curves on region of interest (ROI).
All patients underwent transurethral resection (TURBT); bladder wall with the detrusor muscle underlying
the lesion was sent separately to histopatologic evaluation according to EAU Guidelines recommendations.
Perfusion kinetics have been classified into 4 patterns: type I “rapid wash-in, slow wash-out”, type II “rapid
wash-in and wash-out”, type III “slow wash-in and wash-out”, type IV “slow wash-in, rapid wash-out”.
RESULTS
Overall, conventional GS-US plus CEUS identified 110 of the 134 bladder lesions discovered during cystoscopy.
At histopathological evaluation all tumors resulted transitional cell bladder carcinomas; of these, 36 (32.8%)
were Ta low-grade (LG), 8/110 (7.2%) Ta high-grade (HG), 60/110 (54.5%) were T1 HG and 6/110 (5.5%)
T2.. It was found a significant correlation between type I and II patterns and high-grade carcinomas, while
low-grade lesions usually presented type III-IV curves (p=0.0032). Mean (range) peak of signal intensity (SI)
enhancement of high-grade tumors was 41(35-55)% while lower mean (range) peaks of SI enhancement such
as 28(17-32)% resulted to be more representative of low-grade lesions (p=0.00681). The correlation between
CEUS plus T/IS curves and pathological staging resulted statistically non significant (p=0.18). With regards to
the small series, the T/IS curves showed a sensibility of 86.5% and a specificity of 91.2%. CEUS demonstrated
a matching diagnosis with histopathological evaluation in identifying the depth of bladder wall invasion in
6/8 (75%) of Ta LG, 13/36 (36.1%) of Ta HG, 37/60 (61.7%) of Ta HG and in 5/6 T2 cases (83.4%) It was
found a significant correlation between CEUS and histopatology in the evaluation of the depth of bladder
wall invasion in Ta LG Vs T2 cases (p=0.00297) meanwhile it resulted non significant in characterizing Ta
HG from T1 HG tumors (p=0.216). T/IS curves showed a sensibility of 100% and a specificity of 83.4% in
identifying cT2 tumors
CONCLUSIONS
Contrast-enhanced ultrasound can be useful to better define bladder carcinomas: time/intensity shapes and the
quantitative analysis of contrast kinetics may help in distinguish biologically aggressive urothelial tumors to
low-grade lesions. Wider series may conduce to a more accurate predictivity of T/IS curves and to develop
a tailored preoperative planning and timing; moreover CEUS may be useful in postoperative follow-up of
patients with Ta-T1 tumors non suitable to the recommended repeated cystoscopic schedule.
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Scopo del lavoro
TURBt is the standard initial therapy for superficial bladder neoplasms. Up to 70% of patients with NMIBC
will develop a recurrence after the TURBT. The aim of this study was to evaluate, after a WL TURBt, the
efficacy of identifying persistent BC on margins and bed of resection by comparing the predictive power of
the WL visible lesions versus NBI
Materiali e metodi
From June 2010 to April 2012, 797 consecutive patients, 423 male and 374 female, affected by primitives
or recurrences or suspicious non-muscle invasive bladder tumours, underwent WL plus NBI cystoscopy
following a WL Bipolar Gyrus PK TURBT. The average follow-up was at 24 (16-38) months. Indication of
suitability for TURBt was provided on the basis of the EAU Guideline 2010. All patients provided written
informed consent prior to the study. All procedures were carried out initially by performing a WLcis. The
characterization of the sites, including the number, size and appearance of the neoplasms, were recorded
on a topographic bladder map. Then a NBIcys was carried out to confirm what had been seen in the WL
examination, and to report suspicious areas with NBI. These data, too, were recorded on the topographic
bladder map. All endoscopic resections performed with a Gyrus PK scalpel, bipolar generator (Olympus,
Tokyo, Japan). Resection of each lesion was carried out with WL, whilst a resection of surgical margins was
performed along with the bed of surgical resection using only NBI. Istological specimens sent separately.
Risultati
A total of 797 patients were enrolled in this study. In our experience we observed an overall suspicious
bladder lesions detection rate by 1572 bladder lesions. Of those, following WLTURBt, bladder neoplasms
were 1051 (66,85%) thus 521 were negative (33,14%). Table 1 All the WL TURBt patients underwent
another resection of the margins and the bed this time using NBI device. We found 521 persistent neoplasms
(33,1%). Tables 2, 3 and 4. Using NBI light after WL TURBt we identified 23 MIBC (4,41%): 7 of these
neoplasms (1,31%) showed a negative WL but positive NBI
Discussione
Using NBI after WL TURBt gave us the chance to identify patients affected by bladder primitive malignant
lesions 80% more than those with recurrence lesions, by multifocal neoplasm 7 times more than those with
unifocal, by 3cm. Moreover NBIdevice identify 8 times more CisHG and more than 3 times a pTaLG area
invisible using WL TURBt.
Conclusioni
NBI after WL TURBt enhances the possibilities to find persistent lesions in more than 30% of the cases: 440
(84,45%) positive border lesions, 126 (24,18%) positive bed lesions and 126 (24,18%) positive border and
bed lesions together. Statistical analysis showed that NBI enhance significantly the possibilities to identify
invisible WL lesions such as multifocal (p
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Is there a correlation regarding focality, dimension and status of
bladder tumor at preoperative NBI cystoscopy and at TURBT? Does NBI
increase the ability to detect non-muscle invasive bladder neoplasms?
Preliminary experience in a single centre.
Barbara Cristina Gentile, Roberto Giulianelli, Luca Albanesi, Francesco Attisani, Luca Mavilla, Gabriella
Mirabile, Francesco Pisanti, Daniele Baldoni , Francesca Pallant, Giorgio Vasselli, Manlio Schettini.
Aim of the study
Bladder cancer remains an important and hard to treat pathology in modern urology, as it is considered the
most expensive tumour with regard to both costs per patient per year, as well as lifetime costs per patient. Up
to 70% of patients with NMIBC will develop a recurrence after the TURBt.
The purpose of this study was to assess how the use of preoperative NBI cystoscopy compared with the WL
cystoscopy, related to focalities and dimension after TURBT, increases our predictive power of identifying
non-muscle invasive bladder lesions.
or recurrences or suspicious non-muscle invasive bladder tumours, underwent WL plus NBI cystoscopy and
following to WL Bipolar Gyrus PK TURBT. The average follow-up was at 24 (16-38) months.
Indication of suitability for TURBt was provided on the basis of the EAU Guideline 2010. All patients
provided written informed consent prior to the study. All procedures were carried out initially by performing
a cystoscopy with white light. The characterization of the sites, including the number, size and appearance
of the neoplasms, were recorded on a topographic bladder map. At this a cystoscopy with NBI was carried
out to confirm what had been seen in the white light examination, and to report suspicious areas with NBI
light. These, too, were recorded on the topographic bladder map. All endoscopic resections were performed
with an Gyrus PK scalpel, bipolar generator (Olympus, Tokyo, Japan). All histopathological evaluations were
performed by a single pathologist based on the 2004 WHO classification.
The follow-up was performed in according to the EAU Guide lines 2010.
Results
In this study, a total of 797 patients were enrolled. In our experience we observed 1572 suspicious bladder
lesions. We identified 194 patients (24,3%) with lesions visible only at NBI light, and an overall number of
visible lesions of 234 (14,8%).
Tab 1
Percentual
wl+nbi11
0,70%
1326
84,40%
wl-nbi+
234
14,89%
wl-nbi0
0,00%
totale
1571
100,00%
272
Of those, following WLTURBt, bladder neoplasms were 1051 (66,85%) in 512 patients than 521 were negative
(33,14%). In our experience, regarding to focalities, dimensions and status, we observed an overall increased
bladder lesions detection rate by 99 pts. (12,42%). (see Table 2).
Table 2
WL cisto pos
WL cisto pos
WL cisto neg
NBI cisto neg
NBI cisto pos
NBI cisto pos
UNIFOC pts (%)
11(100)
314(23.68)
171(73.08)
MULTIFOC pts
0
1012(76.32)
63(26.92)
(%)
< 3 cm pts (%)
> 3 cm pts (%)
10(90.91)
1(9.09)
606(45.70)
720(54.30)
204(87.18)
30(12.82)
Primitive pts (%)
10(90.91)
767(57.84)
133(56.84)
Recurrence pts (%)
1(9.09)
559(42.16)
101(43.16)
In our experience, using NBI cystoscopy significantly increased our predictive power to identify lesions not
visible with WL cystoscopy, both unifocal (p< 0,0001), and < 3 cm (p<0,0001), and primitive (p<0,02).
The relative risk (R.R.) of finding with WLTURBT, a bladder tumor using NBI cystoscopy is about seven
time greater for a unifocal lesion, and about nine time greater if it is a lesion < 3 cm and 4 time greater if the
lesion is a primary one.
Conclusions
In our experience, we observed in NBI positive and WL negative Cystoscopy group, an overall increased
bladder lesions detection rate by 12,42%(99 pts. ). Of those, NBI cystoscopy increased overall detection
rate in unifocal than multifocal ( 73,08% vs 26,02%), < 3cm than >3cm (87.18 % vs 12.82%) and primitive
than recurrence (56.84% vs 43.16%). Importante is the use of NBI cistoscopy in identifing unifocal lesions
(p< 0,0001) and < 3cm (p<0,0001), otherwise not visible, with a relative risk 7 time greater than using just
WL cystoscopy.
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Is There a correlation between preoperative NBI cystoscopy and pT
and grading after TURBT to increase the ability to detect non-muscle
invasive bladder neoplasms? PRELIMINARY EXPERIENCE IN A SINGLE CENTRE.
Barbara Cristina Gentile, Roberto Giulianelli, Luca Albanesi, Francesco Attisani, Luca Mavilla, Gabriella
Mirabile, Francesco Pisanti, Daniele Baldoni, Francesca Pallante, Giorgio Vasselli, Manlio Schettini.
INTRODUCTION
Bladder cancer remains an important and hard to treat pathology in modern urology, as it is considered the
most expensive tumour with regard to both costs per patient per year, as well as lifetime costs per patient. Up
to 70% of patients with NMIBC will develop a recurrence after the TURBt .
The aim of this study was to assess how the use of preoperative NBI cystoscopy respect to the WL cystoscopy,
regarding pT and grading after TURBT, increases our predictive power of identifying non-muscle invasive
bladder lesions.
or recurrences or suspicious non-muscle invasive bladder tumours, underwent WL plus NBI cystoscopy and
following to WL Bipolar Gyrus PK TURBT. The average follow-up was at 24 (16-38) months.
Indication of suitability for TURBt was provided on the basis of the EAU Guideline 2010. All patients
provided written informed consent prior to the study. All procedures were carried out initially by performing
a cystoscopy with white light. The characterization of the sites, including the number, size and appearance of
the neoplasms, were recorded on a topographic bladder map. At this a cystoscopy with NBI was carried out
to confirm what had been seen in the white light examination, and to report suspicious areas with NBI light.
These, too, were recorded on the topographic bladder map. All endoscopic resections were performed with an
Gyrus PK scalpel, bipolar generator (Olympus, Tokyo, Japan). Resection of each lesion was carried out with
white light, whilst a resection of surgical margins was performed along with the bed of surgical resection using
only NBI light, which was sent separately with a sequence number identifying them. All histopathological
evaluations were performed by a single pathologist based on the 2004 WHO classification.
The follow-up was performed in according to the EAU Guide lines 2010.
RESULTS
In this study, a total of 797 patients were enrolled. In our experience we observed 1572 suspicious bladder
lesions. We identified 194 patients (24,3%) with lesions visible only at NBI light, and an overall number of
visible lesions of 234 (14,8%).
Tab 1
percentual
wl+nbi11
0,70%
1326
84,40%
wl-nbi+
234
14,89%
wl-nbi0
0,00%
totale
1571
100,00%
274
Of those, following WLTURBt, bladder neoplasms were 1051 (66,85%) in 512 patiens than 521 were negative
(33,14%). In our experience, regarding pT and grading, we observed an overall increased bladder lesions
detection rate by 99 pts. (12,42%). Of all, in NBI positive cystoscopy with WL negative cystoscopy group,
we noted an increased bladder lesions detection rate by 45,73% and 54,25%, respectively (see Table 1).
Table 1
WL cisto pos
WL cisto pos
WL cisto neg
NBI cisto neg
NBI cisto pos
NBI cisto pos
pTa pts (%)
6 (54,5%)
607 (45.78)
69 (29.49)
pT1 pts (%)
0
227 (17.12)
23 (9.83)
pCIS pts (%)
0
15 (1.13)
15 (6.41)
pT2 o oltre pts (%)
0
0
0
NO TUMOUR pts
0
413 (31.15)
107(45.73)
(%)
PUNPML pts (%)
5(45,45% )
64 (4.83)
20 (8.55)
LG pts (%)
6(54.55)
408 (30.77)
55 (23.50)
HG pts (%)
0
441 (33.26)
52 (22.22)
NO TUMOUR pts
0
413 (31.15)
107(45.73)
(%)
In our experience, the use of NBI cystoscopy significant increases the ability to detect both CIS lesions (p<
0,0001) and pTaLG ( p<0,0001) in comparison to WL Cystoscopy. In the group of lesions pT1 and pTaHG
we observed an increasing of detection rate using NBI, but not statistically significant (p< 0,51 e p<0,48).
The relative risk (R.R.) of identifying by TURBT a bladder tumor is greater using NBI: 3 times greater is
that is a pTaLG lesion and about 8 times greater if the lesion is a CISHG.
CONCLUSIONS
Overall detection NBI cystoscopy increased suspicious bladder lesions, not visible in WL, in 99 pts.
(12,42%). Of those, NBI cystoscopy increased overall detection rate in pTa, pT1 and CIS pts. about
29.49%, 9.83% and 6.41%, respectively. Regarding to grading, we observed that in NBI Cystoscopy and
WL negative cystoscopy group, overall detection rate were in PUNPML, LG ed HG, 8.55%, 23,5% and
22,2%, respectively. In our experience, the use of NBI cystoscopy significant increases the ability to detect
both CIS lesions (p< 0,0001) and pTaLG (p<0,0001) in comparison to WL Cystoscopy with a relative risk
respectively of 9 and 3 times greater in comparison to patients treated using just WL cystoscopy.
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HOW THE USE OF NBI CYSTOSCOPY CAN INCREASE THE ABILITY TO IDENTIFY NONMUSCLE INVASIVE BLADDER CANCER? PRELIMINARY EXPERIENCE IN A SINGLE
CENTRE.
ROLE OF INTRAVESICAL CHEMOIMMUNOTHERAPY IN THE TREATMENT OF PATIENTS
WITH BCG NON-RESPONDER HIGH RISK NON-MUSCLE INVASIVE BLADDER CANCER
D. D’Agostino , M.Racioppi, L. Di Gianfrancesco , M.Ragonese, A. Filianoti, C. Gandi, A. Calarco, E.
Sacco, F. Pinto, P.F. Bassi.
M. Schettini, F. Pisanti, G. Mirabile, L. Mavilla, B. Gentile, D. Baldoni, F. Pallante, G. Vasselli, R.
Giulianelli (Roma)
Scopo del lavoro
The aim of this study was to evaluate the efficacy in identifying non-muscle invasive bladder cancer by
comparing the predictive power of the white light cystoscopy versus NBI cystoscopy
Materiali e metodi
797 consecutive patients, affected by primitives or recurrences or suspicious non-muscle invasive bladder
tumours, underwent WL plus NBI cystoscopy and following to WL Bipolari Gyrus PK TURBT. All
procedures were carried out initially by performing a cystoscopy with white light. The characterization
of the sites, including the number, size and appearance of the neoplasms, were recorded on a topographic
bladder map. At this a cystoscopy with NBI was carried out to confirm what had been seen in the white light
examination, and to report suspicious areas with NBI light. These, too, were recorded on the topographic
bladder map.
Risultati
A total of 797 patients were enrolled in this study. In our experience we observed an overall suspicious
bladder lesions detection rate by 1572 bladder lesions. We identified 194 patients (24,3%) with lesions
visible only at NBI light, and an overall number of visible lesions of 234 (14,8%). Tab 1 frequency
percentual wl+nbi- 11 0,70% wl+nbi+ 1326 84,40% wl-nbi+ 234 14,89% wl-nbi- 0 0,00% totale 1571
100,00% Of those, following WLTURBt, bladder neoplasms were 1051 (66,85%) thus 521 were negative
(33,14%). Histological findings are shown in Table 2 below Tab. 2 PRIMITIVE RECURRENCE
UNIFOCAL MULTIFOCAL < 3CM > 3 CM pTa pts (%) 436 (63.93) 246 (36.07) 154 (22.58) 528 (77.42)
203 (29.77) 479 (70.23) pT1 pts (%) 166 (66.40) 84 (33.60) 67 (26.80) 183 (73.20) 79 (31.60) 171 (68.40)
pCIS pts (%) 23 (76.67) 7 (23.33) 10 (33.33) 20 (66.67) 22 (73.33) 8 (26.67) pT2 pts(%) 0 0 0 0 0 0 NO
TUMOUR (%) 0 0 0 0 0 0 PUNMPL (%) 74 (83.15) 15 (16.85) 70 (78.65) 19 (21.35) 88(98.88) 1 (1.12)
LG (%) 271 (57.58) 198 (42.22) 139 (29.64) 330 (70.36) 173(36.89) 295 (63.11) HG (%) 354 (71.81) 139
(28.19) 92 (18.66) 401 (81.34) 131(26.57) 362( 73.43) NO TUMOUR (%) 0 0 0 0 0 0 In all, 512 patients
(64,24%) had bladder tumour, 402 (50,4%) were detected by both WLI and NBI and 99 (12,42%) only by
NBI Cystoscopy . Bladder neoplasm ‘s patients positive negative Total wl+ nbi+ 402 190 592 wl+ nbi- 11
0 11 wl- nbi+ 99 95 194 wl- nbi- 0 0 0 Total 512 285 797 Overall false positive detection rate was 35,75%
(285 pts.). Overall we identified 23 muscle invasive lesions (4,41%), 7 of them (1,31%) visible only to NBI
cystoscopy.
Objective
The aim of our study was to assess the efficacy of combined chemoimmunotherapy in the treatment of BCG
failure patients after one induction cycle with BCG.
We evaluated 60 patients with high risk non-muscle invasive bladder cancer (NMIBC), relapsing after a cycle
of immunotherapy; 40 patients were treated with combined therapy with mitomycin C and BCG, 20 patients
were treated with a second cycle of immunotherapy with BCG. Patients responding to induction cycle were
then treated with a maintenance scheme with BCG alone for a year. Primary endpoints of our study were the
rate of recurrence and progression after a mean follow up of 36 months. Secondary endpoints were diseasefree survival and therapy side effects.
Results
After a mean follow-up of 36 months, the absence of recurrence rate was similar in the two groups (77.5% in the
first group and 85% in the second group; at one year, respectively, 64.7% and 67.7%.). The rate of progression
was found to be 17.4% in patients treated with chemoimmunotherapy vs 10% in patients undergoing the second
cycle of BCG. All patients who showed disease progression underwent radical cystectomy. The Kaplan-Meier
curve for disease-free survival showed no statistically significant differences in favor of chemoimmunotherapy.
As for the side effects, no significant differences were documented between the two treatment groups.
Discussion
The search for therapeutic options for patients who do not respond to intravesical therapy is an important
goal in urological oncology. In recent years, several intravesical therapy schemes have been introduced for
BCG non-responder patients who are candidate for radical cystectomy. Chemoimmunotherapy combines and
synergizes the effect of two therapeutic agents with different mechanism of action, and we believe that it can
be included among the therapeutic options for this group of patients. In this study we evaluated the efficacy in
terms of reduction of risk of recurrence and progression after treatment with chemoimmunotherapy, comparing
the results with those of a group of patients undergoing a second cycle of immunotherapy. Combined therapy
has not shown a clear superiority in comparison with therapy with BCG alone.
Conclusions
Chemoimmunotherapy can therefore be considered as an alternative conservative therapy in patients non
responding to treatment with BCG because it represents a safe therapy, but our study didn’t show the expected
benefit from the combination of two treatments with complementary mechanisms of action in comparison
with immunotherapy with BCG alone.
Discussione
Using WL and NBI cystoscopy allowed us to have a sensibility of 80,66% and of 97,85% with a PPV of
68,49% and of 63,74%, respectively. On accuracy we observed a 63,74% and a 62,86% respectively.
Conclusioni
In 797 patiens, following WL cystoscopy, we observed 1572 overall suspicious bladder lesions. Following
NBI cystoscopy we observed an overall increased suspicious bladder lesions detection rate by 24,34 % (194
pts.) and a bladder tumours NBI positive detection rate by 12,42% (99 pts.). Overall false positive detection
rate was 35,75% (285 pts.)
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277
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IMPACT OF A DEDICATED TEACHING PROGRAM ON QUALITY OUTCOMES OF WHITE
LIGHT TURBT
IMPACT OF NARROW BAND IMAGING (NBI) CYSTOSCOPY IN DIAGNOSIS AND FOLLOWUP OF HIGH GRADE NON MUSCLE-INVASIVE BLADDER CANCER: COMPARISON WITH
WHITE LIGHT CYSTOSCOPY
D. D’Agostino, M.Racioppi, L. Di Gianfrancesco, M.Ragonese , A. Filianoti, C. Gandi, A. Calarco, E.
Sacco, F. Pinto, P.F. Bassi.
L. Castaldo, R. Hurle, L. Castaldo, L. Pasini, M. Seveso, G. Taverna, P. Puppo, P. Graziotti (Rozzano)
Scopo del lavoro
To assess the impact of a dedicated teaching program on the quality outcomes of TURBT
Materiali e metodi
Patients with NMIBC, who had undergone complete first resections were registered in a prospectively
maintained database from 1998-2010 at the department of Urology Humanitas Gavazzeni Bergamo Italy.
From 2005 surgeons, juniors and seniors, underwent a dedicated training program with the aim to improve
the quality outcomes of TURBT, 1) presence of detrusor muscle in the specimen, 2) Cis detection rate, 3)
complication rate (namely clinically significant bladder perforation or bleeding), 4) 3 months recurrence rate
or persistence of disease after reTUR. A multivariate logist regression was performed for each outcome, the
variables included in the analysis were experience of surgeon (senior or junior), lesion dimension (< or > 3
cm), single or multiple lesion, low or high grade disease, Ta or T1, surgeon submitted or not to the teaching
program.
Risultati
427 patients were registered in the database, 199 from 1998 to 2004, before the introduction of the
teaching program, and 228 from 2005 to 2010. In regard to the incidence of detrusor muscle, Cis detection,
complications and recurrence, the rate before and after the teaching program were respectively 118/199
(59%) and 187/228 (82%), 12/199 (6%) and 35/228 (15%), 63/199 (32%) and 61/228(27%), 38/199 (19%)
and 15/228 (7%) Results of the multivariate analysis were summarized in table 1.
Discussione
Incidence of muscle in the specimen Cis detection rate Complications rate (bleeding or perforation)
Recurrence/persistence disease rate Odds rations, 95% CI (p) Odds rations, 95% CI (p) Odds rations, 95%
CI (p) Odds rations, 95% CI (p) Senior surgeon 2.3497, 1.4724 - 3.7499 (0.0003) 0.5770, 0.2583- 1.2888
(0.1798) 0.5580, 0.3028- 1.0285 (0.0615) 0.3596, 0.2257- 0.5729 (0.0000) Lesion greater than 3 cm 0.4249,
0.2452- 0.7363 (0.0023) 1.1742, 0.5103- 2.7019 (0.7056) 1.5820, 0.7873 3.1790 (0.1976) 2.3999, 1.41014.0842 (0.0013) Multiple lesion 0.5572, 0.3327- 0.9332 (0.0262) 1.2746 , 0.5902- 2.7524 (0.5368) 0.8998,
0.4504- 1.7975 (0.7649) 2.4387, 1.4960- 3.9757 (0.0003) High grade tumor 0.3969, 0.1674- 0.9409 (0.0359)
134.9510, 33.2884- 547.0901 (0.0000) 1.2734, 0.4362-3.7172 (0.6584) 0.7915, 0.3375- 1.8563 (0.6584) T1
tumor 3.1190, 1.2559- 7.7461 (0.0143) 0.2085, 0.0663- 0.6558 (0.0073) 1.1678, 0.3914 3.4844 (0.7810)
2.2201, 0.9480- 5.1994 (0.0662) Teaching program 3.7029, 2.2997- 5.9621 (0.0000) 4.2944, 1.826110.0989 (0.0008) 0.3005, 0.1578 0.5724 (0.0003) 0.6825, 0.4307- 1.0814 (0.1038)
Conclusioni
The teaching program had a favorable, independent, statistically significant impact for each of the outcome
examined except for the recurrence/persistence of disease.
278
Objective
Prospective single-center study that aims to assess the impact of NBI cystoscopy in the diagnosis and followup of high risk (Ta-T1 G2-3, Cis) non-muscle-invasive bladder cancer (NMIBC) compared with standard
white light cystoscopy (WLC).
We evaluated a total of 54 consecutive cases of patients with a history of high-grade NMIBC. Inclusion
criteria were hematuria and positive urine cytology in patients with a history of high-grade NMIBC with a
negative study of the upper urinary tract. All patients underwent WLC and, sequentially, to NBI cystoscopy as
an additional procedure. Recurrences and/or suspected lesions underwent biopsy or were subsequently treated
with transurethral resection (TURB) or diathermocoagulation.
Results
Of all patients, 14 (25.9%) had suspected tumor recurrence, of which 8 cases (57.1%) were detected with both
NBI and WLC. 6 cases (42.9%) were identified only by NBI cystoscopy: among them, the cold biopsy of
suspected lesions (hyperemic or velvety mucosa) was positive in 4 cases (28.3%).
Sensitivity of white-light cystoscopy compared to NBI in the diagnosis of NMIBC stood at 67.7% vs. 100%,
and specificity at 98% vs. 95%, respectively.
Diagnostic accuracy of NMIBC and carcinoma in situ (CIS) is improved overall with the use of NBI cystoscopy.
Discussion
The flexible urethrocystoscopy plays a vital role in the diagnosis and follow-up of non-muscle invasive
bladder cancer. However, it is increasingly necessary to search for new diagnostic tools that can enhance the
accuracy of such analysis, especially in peculiar situations (flat lesions, carcinoma in situ, etc.). Narrow Band
Imaging (NBI) cystoscopy produces an optical image obtained by the absorption of a special type of light with
particular characteristics by hemoglobin in urothelium vessels; it has a very low penetrative power but is able
to highlight the architecture of vascularized structures putting them in contrast with healthy tissue.
Conclusions
NBI cystoscopy represents a valuable diagnostic complement in patients with NMIBC, with a significant
improvement in quality of vision and consequently in the diagnosis and follow-up of bladder cancer. In our
experience, this approach provides a substantial improvement in the management of non-muscle-invasive
bladder cancer, and may be helpful later, especially during the endoscopic resection of bladder tumor thanks
to better distinction of neoplastic lesion edges from normal bladder mucosa, decreasing the rate of residual
tumor and therefore of early recurrence.
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PREDICTING BLADDER CANCER AT THE EMERGENCY UNIT: THE IMPACT OF
HEMOGLOBIN VALUE
Fluorescence endoscopy: role in high risk non – muscle – invasive
bladder cancer. Our experience.
S. Luzzago, S. Luzzago, M. Moschini, N. Suardi, G. Gandaglia, V. Cucchiara, G. La Croce, C. Scalici
Gesolfo, A. Briganti, R. Damiano, V. Serretta, F. Montorsi, R. Colombo (milano)
Savoca F., D’Arrigo L., Bonaccorsi A., Costa A., Cacciola A., Pennisi M., Aragona F..
Divisione di Urologia - Azienda Ospdaliera Cannizzaro - Catania
Aim of the study
Haematuria represents the most common symptom at presentation in patients with bladder Cancer (BCa).
However, no study has tested the predictors of BCa in patients presenting with haematuria. This prospective
study was aimed to assess the factors associated with the presence of BCa in patients presenting at our
emergency unit due to gross-hematuria.
Objective
The purpose of the study is to verify whether the use of Hexaminolevulinate lead to an improvement of
the diagnostic accuracy of highh risk urothelialnon – muscle - invasive bladder cancer, such as to possibly
influence the therapeutic decision later in patients with positive cytology and / or subjected to re-TUR (trans
urethral resection).
All patients presenting at the emergency unit of our institution for their first episode of gross haematuria
between January and December 2012 were evaluated. All clinical patient characteristics, including the
ongoing antiplatelets and/or oral anticoagulative treatment, were recorded. Demographical, hematological
and pharmacological data wa analyzed in order to predict the diagnosis of primary BCa. Univariable and
multivariable logistic regression analyses were used to test the variables associated with the presence of
BCa.
Methods and Materials
From January 2011 to February 2014 93 patients with positive cytology and / or Re-TUR
indication
underwent TUR of bladder after administration of 50 ml of Hexaminolevulinate (Hexvix®). In all suspicious
lesions is the standard cystoscopy (CS) that the blue light cystoscopy (CB) was performed biopsy and also
bladder mapping.
Results
A total of 367 patients were registered at our emergency unit for gross-hematuria in 2012. Among them,
168 patients (45.8%) with previous history of bladder cancer (n=37, 22.0%), previous traumatic lesions
(n=11, 6.5%) gross haematuria related to previous urological surgery (n= 70, 41.7%) or previous pelvic
radiotherapy (n=50, 29.7 %), we excluded. Of the remaining 199 patients (54.2%), 30 (14.9%) were on
oral anticoagulant therapy and 59 (29.4%) on antiplatelet therapy. After complete clinical assessment, the
reason responsible for haematuria was documented to be: first episode of bladder cancer in 49 (24.6%),
glomerulonephrites in 5 (2.5%), urinary tract infections in 19 (9.5%), prostatitis in 5 (2.5%), urethral
pathology in 3 (1.5%), kidney cancer in 11 (5.5%), urolithiasis in 27 (13.6%), BPH in 53 (26.6%) and
prostate cancer in17 (8.5%), respectively. At univariable analyses, hemoglobin value (HR:0.83; p=0.04) and
age (HR:1.03; p
Discussion
The value of hemoglobin represented at MVA the only predictor of BCa. Other studies are designed in order
to try to predict BCa in emergency room but no one take in considerations the Hemoglobin levels. Due to
the paucity of improvement in the diagnosis improvement of BCa, Hemoglobin could represent a cheap
indicator of first episode BCa.
Results
We enrolled 93 patients with mean age of 64 years, including 58 patients with an indication to re-TUR and 35
with positive cytology. In 58 cases the CS showed residual disease in 22.5%, cystoscopy CB in 35% of cases.
Of the 35 patients enrolled for positive cytology 7 were positive for histological diagnosis of CIS (21.7%) after
CS and 15 patients (43%) after CB. The effectiveness of the CS was 30%, while that of the CB of 51%. In 25%
of cases there was a diagnostic gain by using the CB and in 16% of patients there was a change in therapy due
to the use of the method.
Discussion
This study confirms the validity of fluorescence endoscopy in patients with positive cytology, especially in
suspected CIS. It was also shown that the use of Hexvix®, at a re-TUR, can improve the diagnostic accuracy
of the procedure, leading to change the therapeutic approach than simply using the CS.
Conclusions
In our experience, in accordance with the European Association of Urology guidelines and with literature
data, it is confirmed that the fluorescence cystoscopy is an important tool for the planning of therapeutic
strategy in patients with high risk non-muscle-invasive bladder cancer. Finally, there is a reduction in the rate
of recurrence, but there is no evidence on the progression of the disease.
Conclusions
Twenty-four percent of patients presenting to the emergency unit due to their first episode of gross
haematuria was found with a primary BCa. The hemoglobin value at the time of patient presentation
represents the only predictor of bladder cancer.
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Security of the ureteral ostium resection: plasmakinetic bipolar system
(Gyrus ACMI ®) and influence of adjuvant intravesical chemotherapy
Stefano Masciovecchio, Pietro Saldutto, Elona Toska, Vikiela Galica, Daniela Biferi, Cristian Cicconetti,
Giovanni Giovanditti, Giuseppe Paradiso Galatioto, Carlo Vicentini
(Università degli Studi dell’Aquila, Dipartimento di medicina clinica, sanità pubblica, scienze della vita e
dell’ambiente, S.S. urologia P.O. “G. Mazzini” – Teramo; Direttore: Prof. Carlo Vicentini)
ASSOCIAZIONE TRA PH URINARIO E INSTILLAZIONI ENDOVESCICALI CON
MITOMICINA NELLE NEOPLASIE VESCICALI NON MUSCOLO INVASIVE.
Introduction
In selected cases of endoscopic surgery of bladder cancer, in order to reach an oncologic radicality, could be
required the resection of ureteral ostium. Evidences in the literature show the safety of this procedure using a
monopolar instrument. Some studies show that adjuvant chemotherapy could favour onset of meatal stenosis.
The aim of our work is to evaluate the safety of ostial resection performed by a plasmakinetic bipolar resector
(Gyrus ACMI®) and the influence of the adjuvant intravesical chemotherapy on resected ostium.
We selected 39 patients (pts) with a diagnosis of non-muscle-invasive urothelial bladder cancer with low/
moderate risk of recurrence/progression of disease (sec. EAU Guidelines) to whom was necessary to resect
the ureteral orifice to obtain a complete oncological radicality. Each pts was also subjected to preoperative
imaging evaluation of the urinary tract. All surgical treatments were performed by the same surgeon with
plasmakinetic bipolar resector (Gyrus ACMI®) without ureteral stenting. Each patient receveid early
intravesical instillation of chemotherapy and, when indicated by EAU guidelines, additional instillations. The
follow-up was performed by peri-operative ecography examination of kidneys that it was repeated monthly
for 3 months after surgery. Six months later from surgical operation an Rx-cystography was performed.
Results
Before the surgery 19 pts showed uretero-hydronephrosis caused by neoplastic obstruction of the ureteral
ostium that in all cases was resolved by intervention. Thirty pts were subjected to early instillation (21
with epirubicin-EPR and 10 with mitomycin C-MMC). Twenty-nine patients were subjected to additional
intravesical chemotherapy (12 with EPR and 17 with MMC). During peri-operative kidneys ultrasound we
observed only 1 case of uretero-hydronephrosis “ex-novo” in a patient subjected to early instillation with EPR.
Six months later during the contrastographic study we observed 4 cases of vesicoureteral reflux (2 patients
were, respectively, subjected to early instillation with EPR and MMC. The others 2 subjects did not receive
early intravesical instillation chemotherapy but only additional EPR).
Discussion
In the scientific literature there are no studies conducted to assess the safety of bipolar resection of ureteral
ostium. Some studies reported the onset of ostial stenosis after early adjuvant intravesical chemotherapy. Our
experience demonstrates the safety of bipolar resection of the ureteral meatus also after the use of adjuvant
intravesical therapy.
Conclusion
According to our experience plasmakinetic bipolar system offers high level of safety in the resection of
bladder lesion involving the ureteral orifice. This method performed by experienced surgeon shows limited
and reversible complications also after adjuvant intravesical chemotherapy.
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M. Ingrosso, G. Primiceri, P. Castellan, M. Marchioni, R. Manco, P. De Francesco, R. Castellucci, R.
Tenaglia (Chieti)
Scopo del lavoro
Negli ultimi anni molti autori hanno suggerito senza alcuna significativa evidenza che l’efficacia di
Mitomicina , come chemioterapia localizzata nel trattamento del Carcinoma vescicale non muscolo invasivo,
possa essere potenziata dall’alcalizzazione urinaria. Obbiettivo del lavoro è analizzare l’associazione tra il
ph urinario e l’efficacia delle instillazioni con mitomicina .
Materiali e metodi
Con un’analisi retrospettiva abbiamo valutato 48 pazienti che da gennaio 2010 a gennaio 2014 hanno
eseguito ciclo di induzione con instillazioni endovescicali di mitomicina. Ogni paziente è stato sottoposto,
dopo 4-5 settimane dall’intevento di TURB-T, ad una instillazione settimanale per sei settimane consecutive.
La posologia è stata di Mitomicina C 40 mg in 60 cc di fisiologica con esposizione di 1 ora. Il Ph urinario
è stato valutato in ciascun paziente due giorni prima dell’instillazione tramite l’esame urine completo.
Il controllo citologico e cistoscopico è stato eseguito dopo un mese dal termine del ciclo di induzione. I
pazienti sono stati divisi in due gruppi considerando il ph urinario (cut off 5.5) e le caratteristiche cliniche e
patologiche.
Risultati
Nei 48 pazienti arruolati, di cui 7 donne e 41 uomini, l’età media è stata di 69 anni (range 51-90), non sono
state riscontrate differenze significative per quanto riguarda il grado di differenziazione tumorale, lo stadio
patologico ( 23 pTa, 22 Pt1 e 3 cis). La media del ph urinario durante il periodo di instillazione è stato
5,77 (range 5-7,5). Utilizzando come cut off il valore di ph 5,5 i pazienti sono stati divisi in due gruppi:
18 pazienti con ph < 5,5 e 30 pazienti con ph > 5,5. L’analisi dei dati evidenzia come il ph urinario possa
influire come fattore di rischio per la recidiva del tumore, infatti nel controllo citologico e cistoscopico a tre
mesi risultano liberi da malattia il 70% dei pazienti con ph>5,5 contro il 56% dei pazienti con ph
Discussione
La mitomicina è un agente alcalizzante minimamente assorbito dal circolo sistemico. Per le instillazioni
endovescicali con mitomicina sono in uso nei vari centri diversi protocolli che si differenziano tra loro per
la concentrazione del farmaco, per la durata del tempo di esposizione e per numero di instillazioni. Noi
abbiamo valutato come la variazione del ph urinario durante il trattamento con mitomicina sia associato al
rischio di recidiva. Dalla nostra analisi si evince che i pazienti con ph urinario < 5,5 sono più a rischio di
avere una recidiva del tumore.
Conclusioni
Il ph urinario >5,5, nei pazienti sottoposti ad instillazione endovescicali di Mitomicina, riduce il rischio di
recidiva del tumore vescicale non-muscolo invasivo.
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CAN DAILY INTAKE OF ASPIRIN AND/OR STATINS INFLUENCE THE BEHAVIOR OF NONMUSCLE-INVASIVE BLADDER CANCER? A RETROSPECTIVE STUDY ON A COHORT OF
PATIENTS UNDERGOING TRANSURETHRAL BLADDER RESECTION
CIRCULATING TUMOR CELLS DETECTION HAS INDIPENDENT PROGNOSTIC IMPACT IN
HIGH-RISK NON-MUSCLE INVASIVE BLADDER CANCER
G. Palleschi, A. Pastore , A. Fuschi, C. Maggioni, L. Silvestri, Y. Al Salhi, D. Autieri, A. Ripoli, A. Leto, V.
Petrozza, A. Carbone (Latina)
Aim of the study
This study aimed to evaluate the behavior of non-muscle-invasive bladder cancer(NMIBC)in patients
submitted to transurethral bladder resection(TURB)comparing subjects in chronic therapy with aspirin,
statins, or both drugs to untreated ones.
This retrospective study was conducted on 564 patients diagnosed with NMIBC who underwent TURB
between March 2008 and April 2013.The study population was divided into two main groups:treated (aspirin
and/or statins) and untreated.The treated group was further divided into three therapeutic subgroups:Group
A(100mg of aspirin,daily for at least two years);Group B(20 mg or more of statins,daily for at least two
years);and Group C (100mg of aspirin and 20mg of statins together).
Results
More resections(2,073)and a higher rate of recurrence(54%),number of recurrences(1,073),and number of
lesions in recurrence(mean, 2.44) were observed in the treated group than in the untreated group (p
Discussion
A statistical significance in terms of number of bladder resections was found in those patients treated
compared to those not treated with either drug group(p=0.032).Further evidence is given by the greater
number of patients with relapse of tumor(54%),defined as those who have required at least a second
TURB,as well as the mean number of recurrences per patient,which was significantly greater in the treated
patients (p=0.033).The higher number of lesions in recurrence represents another important result in the
treated group compared to the untreated group(p=0.021).In this analysis,which did not distinguish between
different treatment subgroups,the prognosis of NMIBC for treated patients was worse than that for untreated
patients. In a more detailed analysis, patients treated with aspirin received significantly fewer resections than
did the entire population,which is statistically significant when compared to the untreated group(p=0.042).
Group A also had fewer patients with recurrence(42.9%),fewer recurrences(0.585),and fewer lesions in
recurrence(1.14)than did patients in the other treated groups and in the untreated group (p
Conclusions
Long-term treatment with aspirin in patients with NMIBC can reduce the recurrence tumor risk,the average
number of resections,and the number of lesions in recurrence.In contrast,treatment with statins does not
result in similar reductions and may reduce the beneficial effect of aspirin.
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G. Busetto, R. Giovannone, G. Antonini, C. Raimondi, A. Gradilone, C. Nicolazzo, V. Gentile, E. Cortesi, E.
De Berardinis (Roma)
Aim of the study
High-risk non-muscle invasive bladder cancer (NMIBC) progresses to metastatic disease in 10–15%
of cases, suggesting that micrometastases may be present at first diagnosis. The prediction of risks of
progression relies upon EORTC scoring systems, based on clinical and pathological parameters, which do
not accurately identify which patients will progress.
Aim of the study was to investigate whether the presence of CTC may improve prognostication in a
large population of patients with Stage I bladder cancer who were all candidate to conservative surgery.
A prospective single center trial was designed to correlate the presence of CTC to local recurrence and
progression of disease in high-risk T1G3 bladder cancer. One hundred two patients were found eligible, all
candidate to transurethral resection of the tumor followed by endovesical adjuvant immunotherapy with
BCG. Median follow-up was 24.3 months (minimum–maximum: 4–36). The FDA-approved CellSearch
System was used to enumerate CTC. Kaplan–Meier methods, log-rank test and multivariable Cox
proportional hazard analysis was applied to establish the association of circulating tumor cells with time to
first recurrence (TFR) and progression-free survival.
Results
CTC were detected in 20% of patients and predicted both decreased TFR (log-rank p < 0.001; multivariable
adjusted hazard ratio HR 2.92 [95% confidence interval: 1.38–6.18], p 5 0.005), and time to progression
(log-rank p < 0.001; HR 7.17 [1.89–27.21], p 5 0.004).
Discussion
The present findings provide evidence that CTC analyses can identify patients with Stage I bladder cancer
who have already a systemic disease at diagnosis and might, therefore, potentially benefit from systemic
treatment.
Conclusions
The prognostic significance of CTC presence in our series of patients is strong evidence that some patients
suffering from NMIBC have already a systemic disease at diagnosis and are in need of a systemic treatment
aimed to eradicate systemic tumor cell spread.
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CROMOTRIPSI E TUMORI TCC DELLA VESCICA
FIBRONECTINA: NUOVO MARKER DI DANNO UROTELIALE NELLA TERAPIA ADIUVANTE
INTRAVESCICALE DEI TUMORI VESCICALI NON MUSCOLO INVASIVI
G. Strada, D. Conconi, S. Redaelli, G. Bovo, P. Viganò, L. Dalprà, A. Bentivegna (CINISELLO BALSAMO ,
ITALIA)
Scopo del lavoro
Per cromotripsi si intende la rottura multipla di un cromosoma con ri-assemblaggio caotico dei frammenti
prodotti dalle rotture. Il risultato finale è un cromosoma il cui linkage genico appare rivoluzionato rispetto
al normale e la cui morfologia può cambiare drasticamente. Il fenomeno della cromotripsi, descritto ormai
in diversi tipi di tumore, si presenta quando si applicano tecniche di cariotipizzazione molecolare come
una variazione elevata di tratti di sequenze dello stesso cromosoma sia in termini di aumento del numero
di copie sia in termini di perdita di sequenze per lo più alternate e distribuite lungo tutto il cromosoma. La
cromotripsi è un fenomeno che coinvolge solitamente pochi cromosomi, se non uno solo, in poche cellule,
ma che è stato additato recentemente come una delle cause di resistenza ai trattamenti terapeutici. Lo scopo
del lavoro è stato quello di analizzare il profilo genomico di 20 biopsie di carcinomi a cellule di transizione
della vescica (TCC) al fine di identificare la presenza del fenomeno della cromotripsi nei casi da noi studiati.
Materiali e metodi
E’ stato analizzato il profilo genomico di 20 biopsie di carcinomi a cellule di transizione della vescica
(TCC), di cui 10 alto grado (HG) e 10 basso grado (LG) mediante CGHarray con livello di risoluzione 60K.
Sono stati utilizzati strumenti bioinformatici come UCSC (http://genome.ucsc.edu/) e DECIPHER (http://
decipher.sanger.ac.uk/) per identificare le alterazioni del numero di copie (CNA: “copy number aberrations”)
e per studiare le regioni “calde” predisponenti a rotture del DNA.
Risultati
Il totale delle aberrazioni ovvero “copy number aberrations” (CNA) risultava essere di 403 per i tumori HG
e 92 per quelli LG, con estrema variabilità intertumorale ed altrettanta intratumorale considerando ciascun
cromosoma singolarmente. In particolare si è osservata in 2 casi cromotripsi a carico del cromosoma 6. Il
cromosoma 6 si manifesta alterato con 46 CNA totali nei 20 tumori, pari al 9,3%. In 2 casi, entrambi HG, il
cromosoma 6 presentava 18 e 8 CNA, pari al 39,1% e 17,4% rispettivamente.
Discussione
Si sottolinea che tali percentuali da sole rappresentano il 56,5% delle CNA osservate sui cromosomi 6 dei 20
tumori. Da un’analisi preliminare “in silico” dei break-points delle CNA si può ipotizzare che il meccanismo
alla base della cromotripsi del cromosoma 6 sia mediato da segmenti duplicati ad alta omologia presenti
nelle immediate vicinanze dei suddetti punti di rottura.
Conclusioni
In conclusione, dal nostro studio emerge come una possibile spiegazione dell’osservata variabilità
intertumorale ed intratumorale in questo tipo di tumori possa risiedere nel fenomeno della cromotripsi.
Dallo studio accurato di questo fenomeno, che non sembra colpire in modo casuale il genoma, si potrebbero
identificare regioni “calde” più suscettibili a rotture e quindi nuovi oncogeni candidati e di conseguenza
nuove strategie terapeutiche.
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G. Carità, V. Alonge, G. Caruana, S. Scurria, A. Cangemi, S. Caruso, V. Serretta (palermo)
Scopo del lavoro
La tossicità locale incide sulla qualità di vita dei pazienti affetti da neoplasie vescicali non-muscolo
invasive(NMIBC)e costituisce una delle cause più frequenti di sospensione precoce della chemio/
immunoterapia intravescicale adiuvante. L’identificazione di un marker di danno uroteliale potrebbe essere
utile per la prevenzione o per la diagnosi e trattamento precoci della tossicità topica. Obiettivo dello studio
è stato correlare alla tossicità da terapia intravescicale l’espressione genica della Fibronectina (FN), del
Recettore dell’Epidemal Growth Factor (EGF-R)nel liquido di lavaggio vescicale e l’espressione proteica
del Heparin-Binding Epidermal Growth Factor-like Growth Factor (HB-EGF),potenziali markers di danno
uroteliale(1,2)
Materiali e metodi
Sono stati reclutati 55 pazienti sottoposti a chemio o immunoprofilassi intravescicale con
Mitomicina(40/40),Epirubicina(80/50)e BCG. Dieci volontari di età comparabile sono stati arruolati previo
consenso informato. Sono stati raccolti un totaale di 200 campioni di urine e barbotage prima, durante e
dopo terapia.Per l’espressione genica di FN ed EGF-R è stato isolato l’RNA cellulare usando un Mini Kit
miRNeasy (Qiagen®) analizzato tramite Real Time- PCR,mentre l’HB-EGF nelle urine è stata dosata con
test- ELISA (Abcam®).L’espressione genica è stata valutata con la quantizzazione comparativa (ΔΔCt)
utilizzando il gene endogeno 18s come controllo per normalizzare il segnale relativo all’mRNA. Ogni
reazione è stata allestita in triplice copia per ciascun gene. I valori di espressione genica sono stati presentati
come incremento/decremento in fold rispetto ai casi-controllo(valore di 1).La tossicità è stata classificata
in tre stadi: 0-1.Lieve(no terapia medica),2. Moderata(terapia medica),3. Severa(instillazione posticipata o
somministrazione intravescicale di una soluzione di acido ialuronico e condroitin solfato).
Risultati
Quattordici pazienti(25.5%)hanno dimostrato tossicità di grado 2-3.L’espressione del gene FN è risultata
aumentata fino a 5.8 fold in caso di tossicità moderata-severa, riducendosi con la sospensione ed il
miglioramento sintomatologico. Nei pazienti trattati con soluzione intravescicale di acido ialuronico
e condroitin solfato, unitamente al beneficio clinico l’espressione genica di FN e’risultata 0.6 fold.
L’espressione dell’ EGF-R ed i livelli urinari di HB-EGF non hanno invece mostrato variazioni di rilievo.
Discussione
Diversi studi hanno correlato l’espressione di FN, EGF-R e HB- EGF al danno dell’urotelio
vescicale,soprattutto in caso di cistite interstiziale(1,2).L’FN potrebbe rappresentare un marker di tossicità
locale utile per migliorare la tollerabilità alla terapia intravescicale, migliorando la compliance dei pazienti e
riducendo il tasso di drop out dalla terapia.
Conclusioni
Dal nostro studio preliminare emerge il potenziale ruolo dell’espressione genica della Fibronectina nel
liquido di lavaggio vescicale quale marker precoce di danno uroteliale. Ulteriori esperienze sono necessarie
a conferma dei risultati.
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HYALURONIC ACID VERSUS STANDARD THERAPY FOR THE TREATMENT OF
LOCAL SIDE EFFECTS IN BLADDER CANCER DURING INTRAVESICAL THERAPY: A
RANDOMIZED PROSPECTIVE STUDY
IS LEUKOCYTE TELOMERE LENGHT A PREDICTOR OF BLADDER CANCER MORTALITY?
RESULTS OF A SERIES OF T1G3 PATIENTS.
P. Destefanis, A. Gonella, M. Allasia, A. Battaglia, F. Pisano, G. Melloni, E. Garzino, E. Alessandria, A.
Bosio, P. Gontero, B. Frea (Torino)
Aim of the study
Intravesical chemotherapy (CT) and BCG are the standard treatment for most of the non-muscle invasive
bladder cancers (NMIBC). Side effects are common especially for BCG. Many studies report a relationship
between intravesical toxicity and glycosaminoglycan (GG) damage on the bladder surface. Hyaluronic acid
(HA) is an endogenous GG of extracellular matrix. Some studies suggest that intravesical HA may reduce
these symptoms. We started a randomized prospective study to evaluate the efficacy of HA compared to
the standard therapy (ST). The primary aim is to evaluate the effectiveness of the HA therapy on symptom
relief. The secondary aims are the reduction of inflammation at histopathology findings, the evaluation of the
HA toxicity and the possible improvement of cancer intravesical treatment (as a result of a better compliance
to the therapy). We present an interim analysis.
NMIBC patients during BCG/CT therapy who experienced local toxicity (WHO grade II or III) were
enrolled. Symptoms were evaluated through questionnaires (VAS; IPSS; CPSE-NIH; ICQ-MLUTS; OAB-q
SF and BCG symptoms questionnaire). We collect urinalysis, urine culture, abdominal ultrasound, urine
cytology and cystoscopy (as follow-up scheme). Enrolled cases were prospectively randomized: GROUP
A (GA), HA therapy (instillation of 40mg HA for at least 30 minutes): 1 instillation/week for 6 weeks +
1 instillation/month for 3 months + 1 instillation/every 3 months as maintenance; GROUP B (GB), ST:
oxybutynin hydrochloride (2,5 mg/8 hours until symptom relief) + ofloxacin (200mg/12 hours for 10 days).
The evaluation steps were fixed at 6 weeks, 3 and 6 months and after 1 year.
Results
From December 2011 to March 2014, 17 patients were enrolled (10 GA and 7 GB). In GA none experienced
HA side effects and almost all patients referred a decrease in voiding symptoms. Two patients dropped
out for tumor progression. In GB 3 patients exited the protocol for the oxybutynin toxicity (severe urinary
retention), 3 had mild side effects (dry mouth), 1 finished the protocol with complete benefit. On VAS
pain scale GA has 0,75 score at one-year versus 1,25 recorded in GB. VAS pain relief scale shows a better
improvement during HA than ST (mean scores 8,5 vs 8,1 at 12 months). CPSE-NIH confirmed better results
in GA (mean score 6,75) than in GB (8,75). The ICIQ-MLUTS after 1 year shows excellent symptoms
control in GA comparing to GB (average ratings 5 vs 6,25). All the differences resulted statistically
significant (p< 0,05).
F. Pisano, P. Destefanis, A. Russo, F. Modica, S. Guarrera, G. Fiorito, B. Pardini, A. Allione, R. Critelli, A.
Bosio, M. Allasia, A. Zitella, L. Rolle, C. Sacerdote, G. Matullo, B. Frea, P. Gontero (torino)
Scopo del lavoro
Telomere shortening has been related to chromosomal instability, that may in turn contribute to the
development of several types of cancer as described for smoking-related cancers, cancers of digestive and
urogenital system. Moreover, telomere length has been reported to be associated with increased risk of early
death in elder individuals. The aim of our study is to retrospectively assess the impact of telomere shortening
on bladder cancer survival in a T1G3 population in order to identify a subgroup of patients who should be
considered for early radical cystectomy.
Materiali e metodi
463 male bladder cancer cases (aged 40-75) were included in a prospective hospital-based case-control study
led at our Institution and were recruited during the years 1994-2008. Among them we selected all T1G3 and
we analyzed leukocyte telomeres length (TL) using quantitative real time PCR. The statistical significance
was assessed using t-test and Pearson’s Chi-squared test. The relative risk of death was estimated as hazard
ratios (HR) using unadjusted Cox regression (R version 2.14-2, Survival package). Associations with p≤0.05
(two tailed) were considered significant
Risultati
A total of 118 T1G3 were included in the study but the TL was measurable only in 83 T1G3 cases. Mean age
was 63.7 yrs, mean duration of bladder cancer survival was 6.6 years. Patients with short telomeres showed
a worst survival trend compared to those with long telomeres. Nevertheless, we failed to find a statistically
significant difference between the two groups. This lack of evidence could be due to the small sample.
Discussione
High risk NMIBC have a heterogeneous prognosis, with overall survival at 10 yrs ranging from 78% to 6%.
Even if intravescical therapy with BCG still represents the standard of care, there is a subgroup of patients
with an higher risk of progression and cancer specific death that should be treated with an early and radical
approach. The length of telomeres could be helpful to identify this group of patients.
Conclusioni
Our results showed a clear inverse correlation between TL and tumor aggressiveness, suggesting that
patients with short telomeres should be considered for early radical treatments. A largest series is mandatory
to improve the power of the statistical analysis (accuracy of analysis and obtain the statistical significance).
Discussion
HA therapy shows excellent results on BCG/CT local toxicity management. Data need to be confirmed by
increasing patients. HA appears useful to treat local symptoms and may be presented as a standard protocol
during BCG/CT therapy, to prevent the toxicity and to improve the intravesical treatment of NMIBC.
Conclusions
These preliminary results show that intravesical HA is effective in the treatment of grade II-III BCG/CT
toxicity being superior to ST.
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IS THE COMBINATION OF MULTIPLE MOLECULAR TESTS PREDICTIVE OF WHO NEEDS
A RE-TUR? RESULTS FROM A PROSPECTIVE TRIAL.
OPTICAL BIOPSY WITH CONFOCAL LASER ENDOMICROSCOPY (CLE) : A NEW
TECHNOLOGY FOR DIAGNOSIS OF BLADDER CANCER. PRELIMINARY RESULTS OF A
PHASE II PILOT STUDY
F. chiaradia, S. alba, G. galeone, E. cirillo marucco, V. pagliarulo (bari)
Aim of the study
Several studies have demonstrated that BladderChek® nuclear matrix protein-22 (NMP22) and UroVysion™
fluorescence in situ hybridization (FISH) tests could be useful in improving the diagnosis/follow up of
Bladder cancer. Nonetheless, their clinical significance remains unclear. Our aim is to understand if the
combination of all three molecular tests could be useful in predicting the result of a Re-TUR (Re-Trans
Urethral Resection),thus selecting the patients suitable for a Re-TUR
From August 2011 to July 2013 a cohort of patients with High Risk Non Muscle Invasive Bladder
Transitional Cell Carcinoma (HRNMIBTCC) was prospectively studied. Voided urine cytology, NMP22,
UroVysion™ were tested before and after ReTUR. Re- TUR was performed 4-6 weeks after first TUR,
under fluorescence-guided cystoscopy using hexaminolaevulinate (HAL: Hexvix®, Photocure, Norway).
The sensitivity,specificity, positive predictive values (PPV) for tumor recurrence and accuracy of all 3
techniques were determined.
Results
Overall 51 patients were analyzed. Median age was 65 aa and mean time to Re-TUR was 36 days. Persistent
disease has been observed in 31% of the Re-TUR (in 4 cases a Muscle Invasive Bladder Cancer was
demostrated). The sensitivity for NMP22, UroVysion™ and voided urine cytology was 61, 76 and 66%
respectively. Positive Predictive Value (PPV) was 39.5, 22.5 and 35% respectively. Sensitivity, PPV and
accuracy of all three tests was 70, 40 and 50% respectively.
Discussion
The significant risk of residual tumour after initial HRNMIBTCC lesions has been demonstrated. Persistent
disease after resection of T1 tumours has been observed in 33-53% of patients. Moreover, the tumour is
often under-staged by initial resection. The likelihood that a T1 tumour has been under-staged and muscleinvasive disease is detected by second resection ranges from 4 to 25%. Treatment of a TaT1 high-grade
tumour and a T2 tumour is completely different; therefore, correct staging is important. Patients selection
for Re-TUR is the key point in managing NMIBTCC. There is no consensus about the strategy and timing
of Re-TUR. Most authors recommend resection at 2-6 weeks after first TUR. The procedure should include
resection of the primary tumour site. Because cystoscopies are invasive and because cytology has poor
sensitivity, non-invasive biomarkers have been sought as alternatives to cystoscopy and cytology for the
detection and surveillance of bladder cancer. Our aim was to understand if the combination of all three
molecular tests could be useful in predicting the result of a Re-TUR. Our Preliminary results showed low
accuracy of all three tests with best sensitivity for UroVysion™.The association of NMP22 and voided urine
cytology and of UroVysion™ NMP22 leads to the best sensitivity, however without encouraging results
G. De Luca, M. Brausi, M. Viola, G. Peracchia, A. Romano, M. Foresio, F. Swartz (Carpi)
Scopo del lavoro
Confocal laser endomicroscopy is a new endoscopic imaging technology that could complement white light
cystoscopy by providing in vivo bladder histopathology. We evaluated confocal laser endomicroscopy by
imaging normal, malignant appearing infiammation and suspicious bladder mucosa areas in a pilot study.
Materiali e metodi
Patients scheduled to undergo transurethral resection of bladder tumors were recruited during a 2 month
period. After standard cystoscopy fluorescin was administer intravesically and/or intravenously as a contrast
dye. A 2.6 mm probe based confocal laser endomicroscope was passed through a 17.5 F flexible scope and/
or a 24 F rigid cystoscope to image normal or abnormal appearing areas before and after TUR. The images
were collected with 488 nm excitation at 8 to 12 frames per second. The endomicroscopic images were
compared with standard hematoxylin and eosin analysis of TUR and biopsies of bladder tumor specimen and
suspicious areas.
Risultati
Nine patients were recruited at our center in the last 2 months and trated in 3 OR sessions. 6 patients had low
grade tumors, 1 high grade, 2 patients had dysplasia (mild and severe) + inflammation. Endomicroscopic
images demonstrated clear differences between normal mucosa and low and high grade tumors. In normal
urothelium larger umbrella cells are seen most superficially followed by smaller intermediate cells and the
less cellular lamina propria. Low grade papillary tumors demonstrate densely arranged but normal-shaped
small cells in multiple layers (>6). High grade tumors show markedly irregular architecture and cellular
pleomorphism. Some artifact were often present which were delete during slide preparation
Discussione
We report one of the first experience in vivo done in europe of confocal laser endomicroscopy in the urinary
tract. Differences among normal urothelium , low grade and high grade tumors was observed.
Conclusioni
We defined specific CLE image interpretation criteria for in vivo characterization of inflammation, dysplasia,
cis and tumor ( fig.1)
Conclusions
Our preliminary results suggest these tests do not offer advantages in selecting patients suitable for a ReTUR, even if the number of patients was small and this study in still on going
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PATIENT’S COMPLIANCE TO INTRAVESCICAL BCG IN ROUTINE CLINICAL PRACTICE,
RETROSPECTIVE ANALYSIS OF 411 CONSECUTIVE PATIENTS.
RESEZIONE AMBULATORIALE CON CAPPIO DI NEOPLASIE NON MUSCOLO-INVASIVE
DELLA VESCICA: TECNICA E RISULTATI
V. Serretta, V. Alonge, C. Scalici Gesolfo, F. D’Amato, A. Solazzo, L. Rocchini, M. Moschini, R. Colombo
(Palermo)
F. Peraldo, A. Curotto, D. Panarello, M. Valcalda, G. Carmignani, A. Simonato (Genova)
Aim of the study
BCG maintenance for at least one year is advocated by urological guidelines as the best intravesical regimen
in high-risk non muscle invasive bladder cancer (NMIBC), conservatively treated. Noteworthy, a relevant
percentage of patients does not complete the planned treatment even if toxicity accounted for less that 10%
of drop outs in recent multi-institutional trials. The aim of this study was to analyze the reasons for treatment
interruption in everyday clinical practice.
Consecutive patients affected by T1HG NMIBC undergoing conservative management with adjuvant BCG
entered the study. The Connaught BCG strain was administered intravesically, at the dose of 81mg diluted in
50 ml of saline solution, according to the South West Oncology Group schedule for one year, starting 21-30
days after TUR. Toxicity and causes of treatment interruption were recorded.
Results
Between 2000 and 2012, intravesical BCG with 1-year maintenance regimen was proposed to 411 patients.
Out of them, 380 (92,5%) completed the induction cycle and 308 (81%) started the maintenance. A total
of 215 (52.3%) completed one year of treatment. Patients’ compliance decreased from 81% at 3 months to
56.6% at 12 months. Toxicity requiring treatment interruption was recorded in 25 (6.1%) patients only. In
60 patients (14.6%) a delay of one or more instillations was necessary. Noteworthy, grade-I toxicity, not
requiring therapy interruption or delay on urologists’ judgment, was recorded in 193 (46.9%) cases. The
retrospective nature of the study represents its major limit.
Discussion
Although one year BCG maintenance is recommended by both European Association of Urology (EAU)
and National Comprehensive Cancer Network (NCCN), and indicated as the elective intravesical adjuvant
regimen in intermediate- and high- risk NMIBC, conservatively treated, patients who complete the planned
schedule doesn’t exceed 50%. According to recent literature BCG-related toxicity shouldn’t represent
the major limiting fact. In the present experience, the high drop-out rate from treatment could be meanly
attributable to grade-I toxicity underestimated by the urologists and to inadequate counselling.
Conclusions
Severe toxicity caused BCG interruption in a limited amount of cases. Almost 60% of treatment
interruptions could be attributable to lack of patient’s counseling and low grade toxicity.
Scopo del lavoro
Dal 2003 presso il nostro Centro è stata utilizzata una procedura ambulatoriale di resezione di neoplasie
vescicali non muscolo invasive (NMIBC) basata sull’utilizzo di ansa diatermica a cappio. Lo scopo del
lavoro è valutare retrospettivamente i risultati ottenuti
Materiali e metodi
Dal 2003 al 2013 sono stati sottoposti a resezione con cappio (RC) 220 pazienti (pz): la tecnica è
ambulatoriale, e consiste nell’introduzione attraverso un cistoscopio flessibile di un’ansa diatermica a
cappio che permette resezione en-bloc meccanica della neoformazione e la coagulazione. L’età mediana
è 74 anni e l’età media 73 (range 42-95), 43 (28,6%) pz avevano più di 80 anni. I pz sottoposti a RC
presentavano comorbidità tali da aumentare notevolmente i rischi anestesiologici/chirurgici o presentavano
controindicazione alla sospensione della terapia anticoagulante/antiaggregante. Il 32,7% (70) era naive, il
67% (148) presentava una recidiva di NMIBC: stratificando in classi di rischio secondo le tabelle EORTC
il 16,7% (25) era a basso rischio, il 42% (63) a rischio intermedio ed il 36,6% (55) ad alto rischio. Le
neoformazioni erano tutte papillari ed inferiori a 2 cm. Nel 65% (143) era presente una sola lesione, nel
33,3% (75) le lesioni erano plurifocali (8 pazienti presentavano più di 8 lesioni)
Risultati
Dei 220 pz sottoposi a RC: 15 (6.8%) presentavano lesione benigna; 43 (19.5%) pTaG1; 99 (45%) pTa G12, G2; 51 (23,2%) pTa G2-3, G3, pT1; 4 (1,8%) Cis; 1 (0,5%) pT2; 7 (3,2%) altro. 34 pz sono stati persi al
follow-up (FU), il FU medio e mediano dei restanti 186 pz è stato di 38 e 31,7 mesi rispettivamente. Le 20
re-TURB, eseguite in pz con riscontro di lesioni di alto grado o pT1 alla RC, hanno evidenziato: in 5 casi
assenza di malattia residua, in 13 conferma di stadio e grado e in 2 presenza di pT2. Durante il FU hanno
presentato recidiva 95 (51%) pz: 24 (42.1%) tra i pz naive e 71 (55%) tra i pz plurirecidivi. Il tempo medio
alla recidiva è stato di 16.5 mesi (mediana 8 mesi)
Discussione
Dei pz naive sottoposti a RC l’84% ha presentato lesioni di basso grado con tasso di recidiva al primo
controllo del 21,3%. Il 16% presentava lesioni di alto grado con recidività del 30%. Tra le RC di lesione
recidiva quelle di basso grado (65%) presentavano recidività del 47% analoga a quella dei pazienti con
lesioni di alto grado (35%). Dai dati analizzati la RC risulta una tecnica affidabile ed utilizzabile in pz con
rilevanti comorbidità, permettendo di ottenere materiale per l’esame istologico, di stratificare i pz, orientarne
il successivo trattamento ed il FU
Conclusioni
La RC è indicata nei pz con NMIBC che rientrano nella categoria dei “nuissance tumors” per dimensioni(=
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THE IMPACT OF RE-TUR ON CLINICAL OUTCOMES IN A LARGE COHORT OF T1G3
PATIENTS TREATED WITH BCG.
TRANSITIONAL CELL CARCINOMA (TCC) IN RENAL TRANSPLANT PATIENTS: A 20 YEARS
RETROSPECTIVE ANALYSIS
F. Pisano, R. Sylvester, V. Serretta, S. Di Stasi, R. Colmbo, A. Briganti, T. Cai, R. Bartoletti, S. Shariat, J.
Palou, M. Oderda, F. Soria, M. Barale, G. Tasso, P. Gontero (torino)
A. Bosio, F. Pisano, A. Palazzetti, M. Allasia, F. Lasaponara, E. Dalmasso, M. Barale, M. Agnello, P.
Destefanis, G. Paquale, O. Sedigh, E. Alessandria, S. Santià, L. Biancone, L. Biancone, G. Segoloni, D.
Fontana, B. Frea, P. Gontero (Torino)
Scopo del lavoro
Re-TUR is strongly advocated for T1G3, because of the high incidence residual disease and mainly the risk
of substaging. Its real clinical value remains to be determined and the clinical factors that may influence
the decision. Some authors suggest that when muscle is present in the specimen, re-TUR may be avoided.
To evaluate if the presence of muscle or not at the first TUR in T1G3 bladder cancer makes a difference in
recurrence, progression and cancer specific survival after re-TUR.
Materiali e metodi
In a large retrospective cohort of 2530 primary T1G3 initially treated with BCG, 953 (37.7%) had a re-TUR.
According to the presence or not of muscle in the specimen of primary TUR, patients were divided in 4
groups: group 1 (no muscle, no re-TUR), group 2 (no muscle, re-TUR), group 3 (muscle, no re-TUR) and
group 4 (muscle, re-TUR). Clinical outcomes were compared across the 4 groups.
Risultati
Table 1 shows the distribution of prognostic factors and clinical outcomes across the 4 groups. Large
tumours and multifocal tumours were more likely to have received a re-TUR independent of whether or not
the primary specimen contained muscle. Re-TUR had a significant impact on progression, cancer specific
(CSS) and overall survival (OS) only when muscle was not present in the primary specimen. When adjusting
for the most important prognostic factors including age, tumour size and the presence of CIS, re-TUR in the
absence of muscle maintained a positive impact on time to progression (HR 0.44, p=0.048), CSS (HR 0.31;
p=0.067), and OS (HR 0.50; p=0.060) and showed a borderline effect on time to first recurrence (HR 0.69;
p=0.100). Re-TUR in presence of muscle in the primary specimen did not improve the outcome for any of
the endpoints after adjusting for prognostic factors.
Discussione
Even if re TUR is recommended in high risk tumors, it can delay the intravescial therapy. When muscle is
present in TUR specimen the risk of substaging or residual tumor should be balanced with the need of keep
on with adequate treatments.
Conclusioni
Our retrospective analysis shows that re-TUR may not be mandatory in T1G3 patients when muscle is
present in the specimen of the primary TUR.
Scopo del lavoro
Transitional Cell Carcinoma (TCC) in renal transplant patients is rare but aggressive. Immunosuppression
plays a role in its pathogenesis. The best clinical and surgical management of TCC in this population is
unclear due to the low incidence of the disease. Aggressive surgical strategies have been proposed. We
report on the management of TCC in renal transplant patients in the Transplant Centre of Torino in the last
20 years.
Materiali e metodi
2581 renal transplants were preformed in the Transplant Center of Torino from 1981 to 2011. We made a
retrospective analysis on the last 20 year activity. Clinical reports were reviewed looking for TCC diagnosis,
treatment and prognosis. 10 cases of TCC were identified: 9 bladder TCC, 1 upper urinary tract TCC (in the
graft renal pelvis).
Risultati
9 patients were diagnosed with bladder TCC, 5 (55,6%) were males. Mean time from transplant to
diagnosis was 87,5 months (SD 59.7) Mean tumor size was 2.1 cm (SD 0.8) at diagnosis, 5 (55,6%) were
multifocal. pTaG1 was diagnosed in 3 () patients (), pTaG3 in 1 () and pT1G3 in 5 () (1 associated with
CIS). 6 patients (66,6%) received intravescical chemotherapy (5 mitomicine C, 1 epirubicine),while BCG
immunoprophylaxis was not used. Recurrence and progression rate was 66,6% and 33,3% respectively
(1 had metastatic disease at pT2 diagnosis). Among patients with an initial diagnosis of pT1G3 TCC, 1
underwent early cistectomy,. In our series, 3 patients (33,3%) received raidcal surgical treatment (cistectomy
and or native nephroureterectomy+graft urinary diversion). At a mean follow up of 49.5 months (SD
47.1), 5 (55.5%) patients, 3 (33.3%) due to bladder cancer. The patient with renal pelvis TCC had a double
kidney transplantation. The tumor was diagnosed 4 years after the transplantation because of hematuria. A
nephroureterectomy of the involved graft was performed. A pT3G3 TCC was histologically diagnosed. After
a two-years follow-up the patient is in good health conditions, free from recurrences and progression, but
under dialytic treatment.
Discussione
Treatment of TCC in transplant patients is challenging. Tumor often develops years after renal
transplantation. In our retrospective analysis low-risk tumors had a good long-term prognosis and pTa
stage at diagnosis was highly predictive for long-term survival. High-risk tumors, particularly pT1G3 in
our series, had on the contrary a very poor prognosis with no long-term survival despite aggressive surgical
management. Variations in immunosuppressive regimen and optimization of intravescical prophylaxis
should play a role in the treatment of the disease.
Conclusioni
TCC in transplant patients had a worst prognosis. High risk non muscle invasive bladder cancer shuold
be considered for early radical treatment in order to prevent progression and cancer specific mortality.
However, large series and meta-analysis are mandatory to draw conclusions on this challenging issues
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C’E’ SPAZIO PER LA CISTECTOMIA LAPAOSCOPICA? RISULTATI ONCOLOGICI E
FUNZIONALI IN UN UNICO CENTRO
CLINICAL OUTCOMES FOLLOWING SEMINAL VESICLE SPARING
CYSTOPROSTATECTOMY (SVSC) IN 26 PATIENTS: 5-YEARS FOLLOW-UP.
V. Varca, G. Mombelli, A. Granata, F. Pietrantuono, S. Ranzoni, F. Scieri, A. Romanò, D. Perri, G.
Sampogna, G. Incarbone, F. Gaboardi (Milano)
E. Belgrano, S. Siracusano, M. Brausi, G. De Luca, S. Ciciliato, F. Visalli, T. Silvestri, L. Toffoli, R.
Tallamini (Trieste)
Scopo del lavoro
La cistectomia radicale con linfoadenectomia pelvica open è il trattamento gold standard per il cancro
invasivo della vescica.Tuttavia, negli ultimi anni le tecniche mini-invasive come la cistectomia
laparoscopica (LRC) e robot-assistita (RARC) hanno trovato un notevole sviluppo. Il presente studio valuta
i risultati peri-operatori, ed i risultati oncologici e funzionali a lungo termine delle cistectomie radicali
laparoscopiche effettuate nel nostro centro
Aim of the study
Seminal vesicle sparing cystoprostatectomy (SVSC) has been reported to improve functional results because
there is low risk of damaging the autonomic nerves and the sphincter area. In this study we reviewed 26
cases of SVSC to assess the functional and oncological outcomes in the intermediate-term.
Materiali e metodi
Tra giugno 2001 e dicembre 2009 sono state effettuate nel nostro centro 64 cistectomie radicali
laparoscopiche con linfoadenectomia pelvica. Tutti i 64 pazienti sono stati sottoposti a visita di follow-up
ogni 3 mesi per i primi 2 anni dopo l’intervento chirurgico e ogni 6 mesi per i successivi anni.
Risultati
Le derivazioni urinarie sono state: 5 ureterosigmoidostomie (Mainz puoch), 10 ureterocutaneostomie, 30
Bricker, e 19 neovesciche ileali ortotopiche. Il 20,3% dei pazienti aveva una malattia superficiale, il 40,6%
ha mostrato una malattia in stadio T2, mentre il restante 39,1% dei soggetti aveva una malattia-non-organo
confinata. Un coinvolgimento linfonodale era presente nel 23,4% dei casi (7,8% N1, 15,6 % N2). Abbiamo
trovato un tasso di complicanze peri-operatorie del 25%. Per quanto riguarda il follow-up oncologico, 33
pazienti sono attualmente vivi e liberi da malattia (51,6%), mentre quattro soggetti sono vivi ma hanno
sviluppato recidiva di malattia (1 metastasi linfonodali, 1 recidiva uretrale, 1 metastasi a distanza). 16
pazienti (25%) sono morti per la malattia metastatica. I pazienti con metastasi sono morti dopo una media
di 19 mesi dopo l’intervento chirurgico (min 6 - max 36 mesi). 11 pazienti (17,2%) sono deceduti per cause
non correlate alla patologia della vescica. Per quanto riguarda il risultato funzionale, l’87,5% dei pazienti
non ha avuto complicanze a lungo termine.
Discussione
Anche se la tecnica a cielo aperto rimane il trattamento gold standard per la neoplasia muscolo-invasiva
della vescica, la cistectomia radicale laparoscopica si è dimostrata una tecnica fattibile e oncologicamente
sicura. Dal 2001 al 2008, tutti i nostri pazienti senza controindicazioni per la laproscopia, sono stati trattati
con LRC, con risultati completamente sovrapponibili rispetto alla tecnica a cielo aperto in termini di risultati
peri-operatori, complicanze e risultati a lungo termine. Nel 2008, abbiamo deciso di passare da LRC a
RARC per ridurre lo stress e la fatica per il chirurgo attraverso l’utilizzo della tecnica robotica. Tuttavia,
poiché non tutti i centri urologici potranno avere accesso alla chirurgia robotica, sulla base della nostra
esperienza, suggeriamo di iniziare con la tecnica laparoscopica che, dopo una formazione adeguata, offre
risultati completamente simili alla tecnica aperta con i benefici associati con una tecnica mini-invasiva.
Between April 2004 to August 2012 a selected group of 26 patients underwent SVSC for transitional cell
carcinoma of the bladder. Pre-operatively all patients were continent and sexually active. In all cases the
patients underwent bilateral SVSC. Pathological disease stage was pTa-pT1 in 15/26 cases (57.7%), pT2
in 4/26 cases (15.4%) and pT3 in 1/26 case (3.8%). Urinary continence and potency were evaluated with
validated questionnaires.
Results
The mean follow-up was 62.8 months while the mean age of the patients was 64.4 years. At last follow-up
3/26 patients (11.5%) died for cancer specific disease while 1/26 patient (3.8%) died for no specific cancer
disease. 9/26 patients (34.6%) reported daytime incontinence and 14/26 (53.8%) nighttime incontinence.
In terms of post-operative potency 17/26 (65.4%) were potent. Pelvic recurrences have appeared in 6/26
patients (23.1%) and distant metastases in 4/26 patients (15.4%).
Discussion
The indications to SVSC should be done in selected cases to improve the cancer specific survival of these
patients
Conclusions
The SVSC confirms satisfactoriy functional results in all patients with acceptable survival in the
intermediate term.
Conclusioni
La cistectomia laparoscopica offre i vantaggi della tecnica mini-invasiva con risultati simili alla tecnica open
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CONCORDANCE AND CLINICAL SIGNIFICANCE OF UNCOMMON VARIANTS OF
BLADDER UROTHELIAL CARCINOMA IN TRANSURETHRAL RESECTION AND RADICAL
CYSTECTOMY SPECIMENS
CONFRONTO DEI RISULTATI ONCOLOGICI E PERIOPERATORI DEI PAZIENTI
SOTTOPOSTI A NEFROURETERECTOMIA OPEN, LAPAROSCOPICA E
RETROPERITONEOSCOPICA
D. Tiscione, T. Cai, P. Verze, G. Nesi, C. Selli, C. Terrone, G. Malossini, V. Mirone, R. Bartoletti, S.
IGSUVBC (Trento)
C. Ammendola, F. Nigro, P. Ferrarese, E. Scremin, G. Benedetto, A. Tasca (Vicenza)
Aim of the study
The aim of this study was to evaluate the concordance and prognostic role of histologic variants of bladder
urothelial carcinoma in transurethral resection of bladder tumour (TURBT) and radical cystectomy (RC)
specimens.
Clinico-pathologic information available at the time of radical cystectomy and follow-up data from 4,110
radical cystectomy specimens, collected between January 2000 and December 2009 at 17 tertiary referral
centres were retrospectively analysed and evaluated for the presence or absence of uncommon variants
of bladder urothelial carcinoma. The presence or absence of uncommon variants of bladder urothelial
carcinoma was evaluated on previous TURBT specimens of patients undergoing RC. Cox regression was
used to assess the impact of these parameters on cancer-specific survival (CSS) and the Kaplan Meier test
for disease-free survival was plotted for survival estimate.
Results
Out of 4,110 patients, 579 were found to have uncommon variants of bladder urothelial carcinoma at RC
(14.1%), while 266 (6.4%) at TURBT. A lack of agreement about uncommon variants was observed between
TURBT and RC specimens in the entire population (p<0.001).
Discussion
By using a large multicentre cohort of patients, we found that the concordance of presence of uncommon
histologic variants of urothelial bladder carcinoma between TURBT and RC is low. On the other hand,
when uncommon histologic variants of urothelial bladder carcinoma are identified in a transurethral bladder
tumour resection sample, they are associated with an increased risk of pathologic upstage and dismal clinical
outcome.
Conclusions
The present study shows that the concordance of presence of uncommon histologic variants of urothelial
bladder carcinoma between TURBT and RC is low. Moreover, the presence of uncommon urothelial
variants at TURBT proved to be independent predictor of worse clinical outcome and potential therapeutic
implications that should be taken into account in urologic clinical practice.
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Scopo del lavoro
Valutare I risultati perioperatori e l’efficacia oncologica della nefroureterectomia laparoscopica (LNU)
e della laparoscopia retro peritoneale (RLNU) confrontata con la nefroureterectomia open (ONU) per il
trattamento del carcinoma organo-confinato dell’alto tratto urinario (UUT-UCC)
Materiali e metodi
Studio retrospettivo monocentrico di 61 pazienti non consecutivi, affetti da tumore organo-confinato
dell’alta via escretrice e senza una pregressa diagnosi di carcinoma uroteliale. Di questi, 15 pazienti sono
stati sottoposti a ONU, 19 a LNU e 27 a RLNU. Di tutti i pazienti sono stati raccolti i dati riguardanti le
condizioni pre-operatorie, lo stadio TNM, il grado del tumore, le caratteristiche operatorie e post operatorie,
l’utilizzo di analgesici e l’eventuale recidiva La sopravvivenza è stata stimata mediante il metodo KaplanMeier
Risultati
Il tempo operatorio medio dell’ONU,LNU e della RLNU è stato rispettivamente di 340 minuti (range: 240380), 327 minuti (270-400) e 348 minuti (range: 240-570); la perdita ematica media è stata di 420 mL(300600), 329 mL (280-360) e 250 mL(< 100-900) rispettivamente; il tempo medio di ospedalizzazione per
l’ONU è stato di 10.2 giorni (range 7-13), di 8.7 giorni per LNU (range 6-26) e di 7.6 giorni per RLNU
(range 4-22)
Discussione
In paziente con carcinoma uroteliale dell’alta via escretrice organo-confinato, LNU e RLNU hanno risultati
oncologici simili all’ONU
Conclusioni
La sopravvivenza totale (OS) è stata di 108 mesi per ONU, 107 mesi per LNU e 104 mesi per RLNU
La progressione libera da malattia (PFS) è stata del 77% per ONU, 75% per LNU e 78% per RLNU La
sopravvivenza cancro-specifica (CSS) a 5 anni è stata di 88% per ONU, 83% per LNU e 87% per RLNU
Non ci sono state significative differenze tra ONU, LNU e RLNU in termini di risultati perioperatori, OS,
PFS e CSS.
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IMPACT OF PREOPERATIVE THROMBOCYTOSIS ON PATHOLOGICAL OUTCOMES
AND SURVIVAL IN PATIENTS TREATED WITH RADICAL CYSTECTOMY FOR BLADDER
CARCINOMA
MINIMALLY INVASIVE INTRACORPOREAL URINARY DIVERSION AFTER RADICAL
CYSTECTOMY IN PATIENTS WITH TRANSITIONAL CELL CARCINOMA OF THE BLADDER
S. Luzzago, S. Luzzago, M. Moschini, N. Suardi, V. Cucchiara, M. Bianchi, C. Scalici Gesolfo, R. Damiano,
A. Briganti, V. Serretta, F. Montorsi, R. Colombo (milano)
Scopo del lavoro
The aim of this study was to investigate the impact of pre-operative platelet count on pathologic findings at
the time of RC for bladder cancer (BCa) and post-operative cancer-specific (CSS) and overall survival (OS).
Materiali e metodi
A total of 906 consecutive patients treated with radical cystectomy (RC) for Bca between 1995 and 2012
at a tertiary referral center were included in the study. Thrombocytosis was defined as > 400.000 platelet/
uL, in agreement with the standard assumed by the central laboratory of our institution. Univariate (UVA)
and multivariate (MVA) logistic regression analyses were used to investigate the impact of the pre-operative
platelets count on pathologic stage. UVA and MVA Cox regression analyses were also adopted to predict
both CSS and OS.
Risultati
Mean age at cystectomy was 67.25. The mean and median platelet counts were 242.100 and 227.500. At
mean follow-up time of 41 months, the 2 and 5-year cancer-specific and overall survival were found to be
83.1% and. 75.2% and 68.3 and 59.8%, respectively. At UVA analysis, thrombocytosis was significantly
associated with adverse pathologic disease stage (p≤0.007) and lymph node invasion (p=0.05). Platelet
count was significantly associated to patient survival at UVA analysis (HR 1.76 and 1.39 for OS and CSS,
respectively; all p< 0.05). At multivariate Cox regression analysis, platelet count was documented to be
significantly related only to the OS (HR 1.64,1.03-2.81; P=0.05).
Discussione
Previous studies suggested that different pre-operative hematological parameters may be associated with
both adverse pathological findings at the time of radical cystectomy and post-operative cancer-specific
survival in patients with bladder cancer. However, the prognostic predictive value of pre-operative
thrombocytosis in patients submitted to RC has only been sporadically investigated and never analyzed in a
large series of patients.
Conclusioni
Pre-operative platelet count should be taken into account as a predictive factor of post-operative oncologic
outcomes after radical cystectomy for bladder cancer and patients should be counseled accordingly.
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V. Pizzuti, R. Nucciotti, F. Costantini, F. Viggiani, F. Mengoni, G. Passavanti, C. Brunettini, A. Bragaglia
(Grosseto)
Scopo del lavoro
Robot- assisted radical cystectomy (RARC) and laparoscopic radical cystectomy (LRC) are becoming
increasingly widespread for the treatment of bladder tumor. We present our technique of intracorporeal
urinary diversion and present oncological and functional outcomes focusing specifically on the oncologic
parameters and comorbidity of the procedures.
Materiali e metodi
Single hospital case series from 2009 to April 2013 including 42 selected patients with high grade and/or
muscle invasive urothelial cancer of the bladder without clinical evidence of limph-node involvement and an
American Society of Anesthesiologists (ASA) score < 4 . Group A (N=30) underwent robotic intracorporeal
neobladder after robotic radical cystectomy , whereas group B (N=12) underwent intracorporeal
laparoscopic ileal conduit after laparoscopic cystectomy. The two groups were demographically comparable.
We evaluated the mean age, clinical stage, operative time,blood loss, intraoperative complications and
transfusions, type of diversion, time of catheterization, analgesic consumption, start of oral nutrition, rate of
postoperative complications, length of hospital stay, pathologic diagnosis of the specimen, number of lymph
nodes removed, and the oncologic outcome
Risultati
The mean operative time was 320 minutes (range: 280-380 minutes) for group A and 280 minutes (range:
260-310minutes) for group B. The mean blood loss was 640 mL (range: 370-810 mL) in group A and 410
mL (range: 300-650 mL) in group B. The mean of lymph nodes removed was 22 (range: 16-25) for group
A and 18 (range: 15-23) for group B. Five patients were diagnosed with positive lymph nodes. Surgical
margins were clear in all but one patient. Early complications occurred in 8 patients. Median postoperative
stay was 12 d (range: 8-15).
Discussione
nn
Conclusioni
Laparoscopy/robotic assisted radical cystectomy and minimally invasive intracorporeal urinary diversion
is a safe procedure, like open surgery, but it offers the advantage of minimal invasiveness, represented by
reduced analgesic consumption and early recovery of peristalsis with rapid oral nutrition.
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OUTCOME ONCOLOGICO IN 170 PAZIENTI CON NEOPLASIE DELL’URETERE DISTALE:
URETERECTOMIA SEGMENTARIA VS NEFROURETERECTOMIA
PATIENTS WITH PERIOPERATIVE COMPLICATIONS PRESENTED AN HIGHER RISK
OF CANCER SPECIFIC MORTALITY AFTER RADICAL CYSTECTOMY: A TWO YEAR
MULTICENTRE ITALIAN REAL-LIFE ANALYSIS
A. Benelli, M. Ennas, D. Panarello, F. Gallo, M. Sormani, R. Schiavina, M. Borghesi, M. Gacci, T. Chini, P.
Gontero, A. Gurioli, A. Lissiani, R. Napoli, G. Carmignani, G. Martorana, M. Carini, B. Frea, E. Belgrano,
A. Simonato (Genova)
Scopo del lavoro
La nefroureterectomia (NFU) è ancora considerata il trattamento standard per i pazienti con neoplasie
dell’alta via escretrice. La chirurgia conservativa è stata proposta nei pazienti monorene chirurgici e
funzionali o con neoplasie sincrone bilaterali; per la rarità di questi tumori in letteratura sono presenti poche
esperienze che descrivano risultati a lungo termine, spesso con popolazioni disomogenee. Questo lavoro è in
grado di confrontare i risultati oncologici a lungo termine in un gruppo di pazienti con neoplasie dell’uretere
distale trattati con ureterectomia segmentaria (US) o con NFU
Materiali e metodi
Sono stati valutati retrospettivamente i registri operatori di cinque centri urologici selezionando 521 pazienti
trattati per neoplasie dell’alta via escretrice da Gennaio 2001 ad Agosto 2013. Sono stati considerati i
pazienti trattati per neoplasie dell’uretere distale (pelvico ed intramurale): 80 pazienti sottoposti a NFU
e 90 ad US. Abbiamo paragonato i due gruppi in termini di sopravvivenza globale (SG), sopravvivenza
cancro specifica (SCS) e sopravvivenza libera da recidive (SLR). Sono state eseguite le seguenti tecniche
chirurgiche conservative: 16 reimpianti ureterali su psoas-hitch (17.7%), 19 anastomosi termino-terminali
(21.1%), 52 ureterocistoneostomie dirette (57.7%) e 3 reimpianti su Boari flap (3.3%). Il follow-up medio e
mediano è rispettivamente di 35.1 e 26.1 mesi
Risultati
Lo stadio risulta così distribuito NFU: 13 Ta (16%), 30 T1 (38%), 24 T2 (30%), 13 T3 (16%), US: 35 Ta
(39%), 22 T1 (24.4%), 21 T2 (23.3%) e 12 T3 (13.3%). Abbiamo ottenuto una SG a 5 anni del 78% per i
pazienti trattati con US e del 53% per quelli trattati con NFU. La SCS a 5 anni è rispettivamente del 92%
e 69%. La SLR vescicale a 5 anni è del 43% e 51% nei due gruppi. La SLR nell’uretere controlaterale a 5
anni del 97% e 99%. Abbiamo descritto una SLR nell’uretere omolaterale a 5 aa nei pazienti trattati con US
dell’80%. Sono stati confrontati i risultati ottenuti nelle due coorti di pazienti e le curve di sopravvivenza
risultano significative per la SG (log-rank P=0.003) e la SCC (log-rank P=0.007)
Discussione
Fra i pazienti trattati con l’US, la SG è comparabile con altri studi riportati in letteratura ed è migliore della
SG del nostro gruppo di controllo NFU in modo statisticamente significativo. Questo perché la chirurgia
conservativa risparmia l’unità renale e permette di limitare le note co-morbidità legate ad un approccio più
radicale. Inoltre, la SCS è più alta nel primo gruppo, probabilmente per il fatto che i pazienti candidati ad
una chirurgia conservativa presentano delle caratteristiche di malattia più selezionate (63.4% delle neoplasie
in stadio Ta e T1)
C. De Nunzio, L. Cindolo, F. Presicce, G. Simone, A. Antonelli, P. Bove, A. Celia, C. Ceruti, S. Crivellaro,
M. Falsaperla, B. Frea, M. Gallucci, G. Lo Trecchiano, R. Lombardo, C. Leonardo, A. Minervini, A.
Porreca, B. Rocco, S. Serni, C. Simeone, S. Zaramella, A. Tubaro (Roma)
Aim of the study
Recently the modified Clavien classification system (CCS) has been proposed as the standard method in
grading perioperative complications of radical cistectomy in patients with bladder cancer. Aim of our study
was to evaluate the impact of perioperative complications graded with the CCS and the oncological outcome
of patients treated with radical cystectomy.
A consecutive series of patients with primitive or recurrent bladder cancer treated with radical cistectomy
from April 2011 to March 2012 at 19 centres in Italy were evaluated for complications occurring up to
the end of the first postoperative month. All complications were prospectively recorded and classified
according to the modified CCS. Patients were re-evaluated every six months for two years with a thoracic
and abdomen TC scan to analyze the oncological outcome. Results were presented as complication rates
per grade and overall cancer specific mortality. Chi-square and Kruskal Wallis tests and binary logistic
regression analysis were used for statistical analysis.
Results
348 patients were prospectively enrolled. Mean age was 69 ±9.4 years; mean BMI was 28.5 ± 6.3 Kg/m2.
Mean follow-up was 18 ± 7 months. All patients underwent radical cistectomy. Urinary diversion consisted
in orthotopic neobladder in 91 patients (26%), ileal conduit in 139 patients (40%) and ureterocutaneostomy
in 118 patients (34%%). 179 patients presented an advanged pathological stage (≥pT3a) and 169 a localized
disease (
Discussion
In our experience, using this CCS tool, radical cistectomy is associated with a significant morbidity and a
significant cancer specific mortality in patients with an advanced pathological stage and in patients with
moderate/severe complications occurred during the procedure.
Conclusions
The modified CCS represents a practical and easily applicable tool that may help urologists to classify the
complications of radical cistectomy and to predict the oncological outcome.
Conclusioni
Il trattamento chirurgico conservativo delle neoplasie ureterali distali non determina un peggior controllo
oncologico della malattia rispetto alla NFU. L’atteggiamento conservativo anche in questa patologia, quando
possibile, sembra essere la strada da percorrere per ottenere i migliori risultati sia in termini di SG che di
SCC
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P 295
P 296
PROGRESSION OF T1 HIGH RISK INTO MUSCLE-INVASIVE BLADDER CANCER IS AN
INDEPENDENT PROGNOSTIC FACTOR OF MORTALITY AFTER RADICAL CYSTECTOMY
THE IMPACT OF NUMBER OF LYMPH NODE REMOVED IN THE DETECTION OF LYMPH
NODE METASTASIS: A SENSITIVITY CURVE ANALYSIS.
F. Pellucchi, M. Moschini, L. Rocchini, G. La Croce, V. Cucchiara, F. Bergamaschi, A. Salonia, F. Montorsi,
R. Colombo (Reggio Emilia )
M. Moschini, M. Moschini, N. Suardi, S. Luzzago, V. Cucchiara, G. La Croce, L. Rocchini, F. D’amato, R.
Damiano, A. Briganti, V. Serretta, F. Montorsi, R. Colombo (milano)
Aim of the study
To evaluate the impact of high risk T1 non-muscle invasive (NMIBC) bladder , cancer progression into
muscle-invasive disease (MIBC) on cancer-specific-survival (CSS) after radical cystectomy
Scopo del lavoro
To assess the correct number of lymph nodes (LNs) to removed at Radical Cystectomy (RC) to ensure an
accurate lymph nodes metastasis (LNM) staging.
Overall, 1037 consecutive patients submitted to radical cystectomy (RC) at our institute between 1999 and
2012 were retrospectively evaluated. For the aim of the study, 441 consecutive patients with history of high
risk NMIBC who progressed to MIBC and were submitted to RC or treated with early cystectomy before
progression. Complete clinical and pathological data (including age, gender, number of TUR, pathological
stage at TUR and pathological stage, grade and nodal status at RC) as well as survival status, were
retrospectively obtained from our institutional database. Univariate and multivariate Cox regression analyses
were adopted to assess the impact of progression to muscle-invasive pattern on CSS and to compare the CSS
of patients treated with early cystectomy.
Materiali e metodi
Between 1995 and 2012, 1016 RC for bladder cancer (BCa) were completed at a single tertiary care
institution. Demographical, clinical and pathological variables were recorded for each patient. The
relationship between the number of removed LNs and the probability to find a LNI at definitive pathology
examination was assessed by receiver operating characteristic (ROC) analyses. The ROC curve coordinates
were used to graph the probability of finding LNI according to the number of LNs removed and examined
with a sensibility of 90 and 95%.
Results
Overall, mean age was 65.8 yr (median: 67; range: 35-88). Of the 441 patients, 64 (14.5%) patients were
female and 377 (85.5%) were male. Mean number of TUR before cystectomy was 3,6 (range: 2-15).
261 (59.1%) patients had history of high risk NMIBC who progressed to MIBC and were submitted to
RC; 180 (40.9%) patients were treated with early cystectomy before progression. Overall pathologic
stage distribution was pT0 49 (11.1%), pT1 70 (15.9%), pT2 101 (23.2%), pT3 136 (30.5%) and pT4 in
85 (19.3%). The pathologic nodal status was pN0 in 285 (64.6%), and pN1 in 36 (8.2%) and pN2 in 81
(18.4%), pN3 18 (4,1%). Mean follow-up time was 35 months (range 1-253). At univariate analysis the
progression into MIBC correlated with worst CSS (p
Discussion
T1 high risk NMIBC patients progressing into MIBC have a worst prognosis compared to patients submitted
to early radical cystectomy.
Risultati
Among all patients who underwent RC, the prevalence of LNM was 35.7% (363 of 1016). T stage and
grade, LVI, LND removed, type of BCa at last TUR and N Radiological Stage were strongly associated with
the LNM (all p
Discussione
The objective of our study was to determine the minimum number of LND to remove during RC to
maximize the probability to detect LNM. After assessed this for overall RC population we stratified for
clinical and pathological variables in order to tailoring the extension of LN dissection.
Conclusioni
Our results confirms that an extend pelvic lymphadenectomy is needed in order to improve the sensibility
of LNM staging. Considering the overall population, a minimum 28 nodes should be removed for achieving
an adequate LNM staging (achieve 75% sensibility). In addition, more extended staging lymphadenectomy
could be appropriate in selected cases in which, based on clinical information (such as pre operative CT
scan) there are a low probability to have LNM.
Conclusions
These data should be considered in decision making of these patients.
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P 297
P 298
THE NUMBER OF TRANSURETHRAL RESECTIONS IS AN INDEPENDENT PROGNOSTIC
FACTOR IN PATIENTS WITH MUSCLE- INVASIVE BLADDER CANCER TREATED WITH
RADICAL CYSTECTOMY
THE ROLE OF PERI-OPERATIVE BLOOD TRANSFUSION ON CANCER SPECIFIC AND
OVERALL MORTALITY AFTER RADICAL CYSTECTOMY FOR BLADDER CANCER
F. Pellucchi, M. Moschini, L. Rocchini, G. La Croce, V. Cucchiara, F. Bergamaschi, A. Salonia, F. Montorsi,
R. Colombo (Reggio Emilia)
Aim of the study
To evaluate the impact of the number of previous transurethral resections (TUR) on the cancer-specificmortality (CSM) in patients found with muscle-invasive bladder cancer (MIBC) at the time of radical
cystectomy (RC).
Overall, 1037 consecutive patients submitted to RC at our institute between 1999 and 2012 were
retrospectively evaluated. We selected 697 patients with diagnosis of MIBC at TUR preceding RC,
excluding patients submitted to RC for T1 high risk disease. Complete clinical, pathological data (including
age, gender, number of TUR, pathological stage at TUR and pathological stage, grade and nodal status
after cystectomy) as well as survival status, were retrospectively extract from our institutional database.
Univariate and multivariate Cox regression analyses were adopted to assess the impact of the number of
TURs before RC on CSM.
Results
Overall, mean age was 67.1 yr (median: 68; range: 32-96). Of the 697 patients, 119 (17.1%) patients were
female and 578 (82.9%) were male. Mean number of TURs before RC was 1,7 (median 2,1; range: 1-12).
Overall pathologic stage distribution was pT0 in 56 (8%), pT1 in 48 (6.9%), pT2 in 120 (17.2%), pT3 in
303 (43.5%) and pT4 in 142 (20.4%). The pathologic nodal status was pN0 in 390 (56%), and pN1 in 89
(12.8%), pN2 in 165 (23.7%) and pN3 27 (3,9%). Mean follow-up time was 35 months (range 1-253). At
univariate analysis number of TURs before RC was documented to be significantly correlated with CSM (p
Discussion
The number of TURs before radical cystectomy should be considered as a prognostic predictor of survival.
Conclusions
These results should be taken into account as an useful predictive factor for a more adequate prognostic
stratification of patients after RC.
M. Moschini, M. Moschini, S. Luzzago, N. Suardi, F. D’amato, V. Cucchiara, G. La Croce, L. Rocchini, F.
Pellucchi, R. Damiano, A. Briganti, V. Serretta, F. Montorsi, R. Colombo (milano)
Scopo del lavoro
Only few studies investigated the impact of the peri-operative blood transfusion (PBT) rate on both cancerspecific (CSM) and overall mortality (OM) after radical cystectomy (RC) for bladder cancer (Bca). To date,
no study has taken into account the possible prognostic role of the pre-operative hemoglobin level (Hb). The
aim of this study was to evaluate the impact of both pre-operative Hb level and PBT rate on CSS and OS of
patients who underwent RC.
Materiali e metodi
The study cohort included 1575 patients treated with RC for BCa between 1990 and 2012 at a single tertiary
referral center. Complete clinical, pathological and follow up-data was available for all the patients. KaplanMeier curves were adopted to assess the CSM and OM rates in the comprehensive population. At univariable
(UVA) and multivariable (MVA) Cox regression analyses the impact on CSS and OS of both PBT and Hb
were initially analyzed separately. In a following step, PBT and Hb were simultaneously included in the
same statistical model. Age at surgery, Hb, PBT, pathological T stage, pathological N stage were used as
covariates.
Risultati
Mean age at RC was 67 years. A total of 580 (36.8%) patients received a PBT (mean number of blood units
received: 3). Mean and median Hb values were 12.4 and 12.6 mg/dL (range 8.0-17.5 mg /dL), respectively.
With a mean follow-up time of 41 months, CSS and OS were 83.1 vs. 75.2 and 68.3 vs. 59.8%, at 2 and 5
years, respectively. At UVA, patients who received PBT experienced a CSM (HR: 2.11; p
Discussione
The influence of immune system on bladder cancer is well known even if not completely understood. This
influence can have several consequences. Firstly hematologic disorders, like alteration in hemoglobin
levels, and systemic inflammation. Secondly, the immunomodulation could are caused also by PBT and sub
sequentially has an immunosuppressive effect. Our study, based on a population of patients with BCa (n =
1575) treated with RC demonstrated the impact of PBT on CSS and OS. Despite this, no association was
found at multivariable analysis consider.
Conclusioni
At multivariate statistical analysis, including both the PBT rate and the pre-operative Hb level, only the
latter parameter was shown to be significantly correlated with CS and OM. Further studies are needed in
order to investigate the suggested immunosuppressive effect of the PBT and the suspected influence of the
pre-operative Hb level as a factor favoring the systemic dissemination of BC cells.
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P 299
TRATTAMENTO ENDOUROLOGICO DELLE NEOPLASIE UROTELIALI DELL’ALTA VIA
ESCRETRICE: LA NOSTRA ESPERIENZA NEI CASI DI PRIMA OSSERVAZIONE
A. De Gobbi, L. Bettin, A. Guttilla, F. Zattoni, A. Crestani, M. Iafrate, P. Beltrami, F. Zattoni (Padova)
Scopo del lavoro
Le neoplasie uroteliali rappresentano il quarto tumore in ordine di frequenza e quelle della via escretrice
superiore ammontano a circa il 5-10% delle neoplasie uroteliali. Localizzazioni vescicali concomitanti o
successive al riscontro di una neoplasia uroteliale della via escretrice superiore si presentano nel 22-47% dei
casi. I fattori di rischio più importanti sono rappresentati dal fumo di tabacco e dall’esposizione ad amine
aromatiche. Il gold standard di trattamento è rappresentato dalla nefroureterectomia. Negli ultimi anni
tuttavia il trattamento endourologico si è venuto affermando e rappresenta una valida alternativa terapeutica
in casi selezionati.
Materiali e metodi
Dal dicembre 2009 al marzo 2014 abbiamo trattato 62 pazienti con neoplasia dell’alta via urinaria, di cui
15 di nuovo riscontro trattati in maniera conservativa per via endourologica; di questi, 6 sono stati trattati
con tale modalità per necessità (1 con malattia in asse trapiantato, 5 monoreni chirurgici). I pazienti erano
stati informati sulla necessità di un successivo stretto monitoraggio endourologico. Tutti i pazienti sono
stati sottoposti a cistoscopia, ureteropielografia retrograda con raccolta delle urine dall’asse escretore per
esame citologico, ureterorenoscopia ed eventuale biopsia con pinza o asportazione con cestello della lesione
neoplastica e successiva fotocoagulazione laser fino allo sbiancamento completo della mucosa.
Risultati
10 pazienti sono attualmente in follow-up, mentre 5 sono stati sottoposti a nefroureterectomia: in 2 pazienti
per recidive multiple di basso grado non bonificabili per via endourologica, due per recidive di alto grado
e uno (trattato conservativamente per necessità) con neoplasia istologicamente aggressiva non bonificabile
completamente per via retrograda. Non sono state registrate complicanze maggiori intra o postoperatorie
e la maggior parte gli interventi (85%) è stata effettuata in regime di day hospital. Tra le complicanze
minori segnaliamo febbre per 24-48 ore nel 12% dei casi e un sanguinamento significativo in un caso, che
comunque non ha richiesto trasfusioni di sangue.
Discussione
Il trattamento endourologico delle neoplasie uroteliali della via escretrice superiore rappresenta attualmente
una opzione terapeutica sicura ed efficace. Al trattamento deve obbligatoriamente essere associata una
stretta sorveglianza anche in relazione al fatto che le tecniche di imaging non riescono ad evidenziare lesioni
inferiori a 6-7 mm. L’indicazione nei casi di elezione deve limitarsi a neoformazioni di diametro inferiore ad
1 cm superficiali e di medio-basso grado.
Conclusioni
Il trattamento conservativo delle neoplasie dell’alta via escretrice sembra essere efficace e sicuro; le linee
guida possono pertanto essere interpretate, valutando non solo le dimensioni e l’istologia della neoplasia, ma
la sua aggredibilità per via retrograda e l’eventuale trattamento di necessità.
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