Iatrogenic or recurrent bladder neck contracture treated by the Palminteri-Ferrari technique: a new way to approach a frustrating condition.

PURPOSE: Bladder neck stricture (BNS) is a bothersome disease which may affect patients after trauma or prostatic surgery. It is frustrating due to the low durable success rate of currently available surgical techniques. The aim of the study is to explore the efficacy of a novel technique. MATERIALS & METHODS: The surgical protocol was developed by two high case-volume surgeons. The technique consists of Holmium laser incisions at 3-6-9-12 o'clock. Subsequently, triamcinolone acetonide 40 mg is injected. Two months later, the BNS is endoscopically checked in operatory room and re-procedure take place, if necessary (max 3 times). Failure was defined as the need of definitive urinary diversion. Subjective satisfaction was measured through PGI-I Questionnaire. RESULTS: A total of 45 patients were enrolled. Median age was 63 (IQR 59-69) years and BNS developed by different causes. Naïve BNS procedure patients were 12 (26.7%), others 33 (73.3%) underwent median 2 (IQR 1-4) previous urethrotomies, including 16 other surgeries. Suprapubic bladder catheter was present in 34 patients (75.6%). No complications were registered. Re-procedure at control was necessary in 24 patients (53.3%) for a median of 1 (IQR 1-3) procedures. At median follow-up of 18 months, failures were 4 (8.9%) and urinary incontinence was reported in 2 patients (4.5%) who required incontinence surgery. Median PGI-I was 2. CONCLUSIONS: Our technique of BNS treatment allows good outcomes and high rate of subjective improvement amongst patients. Moreover, naïve patients seem to have better results. However, longer follow-up and higher sample size are mandatory to further assess these data.

Is water vapor thermal therapy safe and feasible in elderly and frail men? The Italian experience.

PURPOSE: In recent years, water vapor thermal therapy (WVTT) has spread as minimally invasive technique in lower urinary tract symptoms due to benign prostatic hyperplasia treatment. Even if its safety and feasibility have been largely proved in young men, nobody has proved the same feasibility and safety in the elderly (men older than 75 years old). Our aim is to compare WVTT safety outcomes in men older than 75 with younger men. METHODS: We prospectively collected data on men who underwent water vapor thermal therapy from 2019. We compared data on operative time, number of injections, intra-operative and post-operative complications, reinterventions rate. RESULTS: We enrolled 426 patients; among these, 60 were older than 75 years old, 366 were younger. Our cohorts of patients had similar results in terms of intra-operative and post-operative complications. Operative time accounts about 11 min for both groups (p = 0.535), total number of injections was seven for young men and eight for elderly (p = 0.314). We found no intra-operative complications in elderly men group and only one in the younger group (p = 0.678), while five younger men underwent clot retention, and two elderly men experienced this complication (p = 0.239). Only one transfusion occurred in the elderly group. No differences between groups occurred in terms of length of stay, post-operative urinary retention and reintervention rate, while catheterization time was longer in the elderly men. CONCLUSION: WVTT is a safe procedure in elderly patients with comparable intra-operative and post-operative complication rate in comparison with younger patients.

Safety and efficacy of GreenLight PVP in octogenarians: evaluation of the Global GreenLight Group database.

INTRODUCTION: The present study analyzes the largest international GreenLight database, the Global GreenLight Group (GGG), to evaluate the functional and safety profile of GreenLight photoselective vaporization of the prostate (PVP) in octogenarians. METHODS: The GGG is a database comprised of patients that underwent GreenLight PVP from 2011 to 2019 performed by 8 experienced urologists at 7 international hospitals. Patients 80 years or older at the time of surgery were categorized as octogenarians. They were compared to a similar group of PVP patients below the age of 80. RESULTS: Among 3,648 patients, 586 men were above the age of 80. Compared to patients under the age of 80, octogenarians had larger prostates (76.0 vs 71.9 ml, p = 0.02) and a lower BMI (25.6 vs 26.7, p = 0.045). Operative time was not significantly longer in octogenarians. The improvement in functional outcomes between 80-year-old patients and control patients was not significantly different at one-year follow-up, with the exception of maximum urinary flow (Qmax) that favoured younger patients (10.3 vs 12.6 ml/s, p = 0.02). The odds of transfusion were greater for older patients [OR 8.2 (95% CI 3.6-18.9, p < 0.01)], but they were not at increased risk of hematuria. Octogenarians had higher readmission rates (23.0 vs 11.9%, p < 0.01). CONCLUSIONS: GreenLight PVP is a safe option in well-selected octogenarians in a cohort of patients treated by surgeons experienced with the technology. The odds of transfusion were higher in patients over 80, but the absolute risk remains low. The 30-day hospital readmission rate was higher in octogenarians.

Functional outcomes of GreenLight 180-W photoselective vaporization in patients with large (≥ 80 cc) prostates: an analysis of over 3000 men in the Global Greenlight Group (GGG) database.

INTRODUCTION: GreenLight photoselective vaporization of the prostate (PVP) has gained widespread adoption as an option to traditional transurethral resection of the prostate. Prior reports expressed concern with the use of PVP in large prostates. The aim of this study was to investigate the adjusted outcomes of GreenLight PVP in men with large (≥ 80 cc) vs. small prostates (< 80 cc). METHODS: Data were obtained from the Global Greenlight Group which pools data from 7 high volume centers. Men with established benign prostatic hyperplasia who underwent GreenLight PVP using the XPS-180 W system between 2011 and 2019 were eligible and assigned into two groups based on their prostate size (≥ 80 and < 80 cc). 11 functional and perioperative covariates were collected. Analyses were adjusted for patient age and presence of median lobe. RESULTS: 3426 men met the inclusion criteria. 34.6% (n = 1187) of patients had a large prostate size. Baseline age and prostate volume were significantly different between the groups. The magnitude of absolute improvement in unadjusted international prostate symptom score was significantly greater in the large (≥ 80 cc) prostate group at 12 months, with an absolute change of 19.17 points (95% CI 18.46-19.88; p < 0.01). There was also a significant drop in PVR at both 6- (p = 0.007) and 12 months (p = 0.005). There were no significant differences in transfusion (p = 0.42), hematuria (p = 0.80), or 30-day readmission rates (p = 0.28). CONCLUSIONS: Greenlight PVP is a safe and effective alternative for patients with prostate sizes ≥ 80 cc, with durable outcomes relatively independent from prostate size.

The role of warm ischemia time on functional outcomes after robotic partial nephrectomy: a radionuclide renal scan study from the clock randomized trial.

PURPOSE: To evaluate the relationship between warm ischemia time (WIT) duration and renal function after robot-assisted partial nephrectomy (RAPN). METHODS: The CLOCK trial is a phase 3 randomized controlled trial comparing on- vs off-clamp RAPN. All patients underwent pre- and postoperative renal scintigraphy. Six-month absolute variation of eGFR (AV-GFR), rate of relative variation in eGFR over 25% (RV-GFR > 25), absolute variation of split renal function (SRF) at scintigraphy (AV-SRF). The relationships WIT/outcomes were assessed by correlation graphs and then modeled by uni- and multivariable regression. RESULTS: 324 patients were included (206 on-clamp, 118 off-clamp RAPN). Correlation graphs showed a threshold on WIT equal to 10 min. The differences in outcome measures between cases with WIT < vs ≥ 10 min were: AV-GFR - 3.7 vs - 7.5 ml/min (p < 0.001); AV-SRF - 1% vs - 3.6% (p < 0.001); RV-GFR > 25 9.3% vs 17.8% (p = 0.008). Multivariable models found that AV-GFR was related to WIT ≥ 10 min (regression coefficient [RC] - 0.52, p = 0.019), age (RC - 0.35, p = 0.001) and baseline eGFR (RC - 0.30, p < 0.001); RV-GFR > 25 to WIT ≥ 10 min (odds ratio [OR] 1.11, p = 0.007) and acute kidney injury defined as > 50% increase in serum creatinine (OR 19.7, p = 0.009); AV-SRF to WIT ≥ 10 min (RC - 0.30, p = 0.018), baseline SRF (RC - 0.76, p < 0.001) and RENAL score (RC - 0.60. p = 0.028). The main limitation was that the CLOCK trial was designed on a different endpoint and therefore the present analysis could be underpowered. CONCLUSIONS: Up to 10 min WIT had no consequences on functional outcomes. Above the 10-min threshold, a statistically significant, but clinically negligible impact was found.

Transurethral water vapor ablation of the prostate with the Rezum system: Urodynamic findings.

AIMS: The efficacy of the transurethral convective interstitial radiofrequency water vapor thermal ablation of the prostate with the Rezum system for the treatment of male lower urinary tract symptom due to benign prostatic hyperplasia is well proven. The improvement of urodynamic parameters obtained from a simple uroflowmetry cannot measure the effect of water vapor injection on the bladder outlet obstruction. METHODS: This monocentric retrospective pilot study analyzes the data of pressure-flow studies performed before and after 17 Rezum procedures to answer the question whether thus obtained ablation of prostate tissue has a disobstructive effect on the bladder outlet. RESULTS: All the functional outcomes were consistently improved after the procedure, with a median flowrate increase of 5.1 ml/s (p = 0.0022) and a median postvoid residual urine (PVR) reduction of 100 ml (p = 0.0042). The prostate volume was reduced by 40% (p < 0.0001) and the median Bladder Outlet Obstruction Index (BOOI) reduction was 53.8 (p < 0.0001). CONCLUSIONS: These data show that the possibility to significantly reduce the obstruction grade with even a single Rezum procedure is concrete and seems to be independent from the degree of the obstruction grade.

The impact of 5-ARI on perioperative and functional outcomes of GreenLight PVP: an analysis of the Global GreenLight Group database.

INTRODUCTION: In this study, we sought to investigate the impact of 5-alpha reductase inhibitors (5-ARI) on the perioperative and functional outcomes of 180-Watt XPS GreenLight photovaporization of the prostate (PVP) using a large international database. MATERIALS AND METHODS: Data were obtained from the Global GreenLight Group (GGG) database, which includes eight high-volume, experienced surgeons from seven international centers.  All men with established benign prostatic hyperplasia (BPH) with known 5-ARI status who underwent GreenLight PVP using the XPS-180W system between 2011 and 2019 were eligible for the study.  Patients were assigned to two groups based on the preoperative use of 5-ARI.  Analyses were adjusted for patient age, prostate volume, and American Society of Anesthesia (ASA) score. RESULTS: We included 3,500 men, of which 1,246 (36%) had preoperative 5-ARI use.  Patients in both groups were similar with regards to age and prostate size.  On multivariable analysis, total operative time was slightly shorter (-3.26 min 95% CI: 1.20 - 5.32, p < 0.01) and required 35.6kJ less laser energy (95% CI: -48.0kJ - -23.3kJ, p < 0.01) for patients on 5ARI compared to those without 5-ARI.  However, no clinically significant difference was appreciated regarding postoperative transfusion rates [OR 0.048 (95% CI -0.82-0.91; p = 0.91)], hematuria rates [OR 0.96 (95% CI 0.72-1.3; p = 0.81)], 30-day readmission rates [OR 0.98 (95% CI 0.71-1.4; p = 0.90)], or overall functional outcomes. CONCLUSION: Our findings suggest that preoperative 5-ARI is not associated with any clinically significant different perioperative or functional outcomes for GreenLight PVP using the XPS-180W system.  There is no role for the initiation or discontinuation of 5-ARI prior to GreenLight PVP.

Efficacy and safety profile of GreenLight laser photoselective vaporization of the prostate in ≥ 75 years old patients: results from the Italian GreenLight Laser Study Group.

BACKGROUND: Benign Prostatic Obstruction (BPO) is the most common non-malignant urological condition among men and its incidence rise with age. Among prostate treatments, GreenLight laser seems to reduce bleeding and would be safer in the aging population. AIMS: We aimed to compare the functional outcomes and safety profile of < 75 years old (Group A) and ≥ 75 years old (Group B) patients. METHODS: In a multicenter setting, we retrospectively analyzed all the patients treated with GreenLight Laser vaporization of the prostate (PVP). RESULTS: 1077 patients were eligible for this study. 757 belonged to Group A (median age 66 years) and 320 to Group B (median age 78 years). No differences were present between the two groups in terms of prostate volume, operative time, hospital stay, PSA decrease over time after surgery, complications and re-intervention rate with a median follow-up period of 18 months (IQR 12-26). Nevertheless, focusing on complications, GreenLight laser PVP demonstrated an excellent safety profile in terms of hospital stay, re-intervention and complications, with an overall 29.6% complication rate in older patients and only two cases of Clavien III. Functional outcomes were similar at 12 month and became in favor of Group A over time. These data are satisfactory with a Qmax improvement of 111.7% and an IPSS reduction of 69.5% in older patients. DISCUSSION AND CONCLUSIONS: GreenLight laser photoselective vaporization of the prostate is a safe and efficient procedure for all patients, despite their age, with comparable outcomes and an equal safety profile.

The prognostic power of inflammatory indices and clinical factors in metastatic castration-resistant prostate cancer patients treated with radium-223 (BIO-Ra study).

PURPOSE: To combine peripheral blood indices and clinical factors in a prognostic score for metastatic castration-resistant prostate cancer (mCRPC) patients treated with radium-223 dichloride ([223Ra]RaCl2). PATIENTS AND METHODS: Baseline neutrophil-to-lymphocyte ratio (NLR), derived NLR (donor), lymphocyte-to-monocyte ratio (LMR), platelet-to-lymphocyte ratio (PLR), systemic inflammation index (SII), Eastern Cooperative Oncology Group performance status (ECOG PS), Gleason score (GS) group, number of bone metastases, prostate-specific antigen (PSA), alkaline phosphatase (ALP), line of therapy, previous chemotherapy, and the presence of lymphadenopathies were collected from seven Italian centers between 2013 and 2020. Lab and clinical data were assessed in correlation with the overall survival (OS). Inflammatory indices were then included separately in the multivariable analyses with the prognostic clinical factors. The model with the highest discriminative ability (c-index) was chosen to develop the BIO-Ra score. RESULTS: Five hundred and nineteen mCRPC patients (median OS: 19.9 months) were enrolled. Higher NLR, dNLR, PLR, and SII and lower LMR predicted worse OS (all with a p < 0.001). The multivariable model including NLR, ECOG PS, number of bone metastases, ALP, and PSA (c-index: 0.724) was chosen to develop the BIO-Ra score. Using the Schneeweiss scoring system, the BIO-Ra score identified three prognostic groups (36%, 27.3%, and 36.6% patients, respectively) with distinct median OS (31, 26.6, and 9.6 months, respectively; hazard ratio: 1.62, p = 0.008 for group 2 vs. 1 and 5.77, p < 0.001 for group 3 vs. 1). CONCLUSIONS: The BIO-Ra score represents an easy and widely applicable tool for the prognostic stratification of mCRPC patients treated with [223Ra]RaCl2 with no additional costs.

Is off-clamp robot-assisted partial nephrectomy beneficial for renal function? Data from the CLOCK trial.

OBJECTIVES: To compare the functional outcomes of on- vs off-clamp robot-assisted partial nephrectomy (RAPN) within a randomized controlled trial (RCT). MATERIALS AND METHODS: The CLOCK study (CLamp vs Off Clamp the Kidney during robotic partial nephrectomy; NCT02287987) is a multicentre RCT including patients with normal baseline function, two kidneys and masses with RENAL scores ≤ 10. Pre- and postoperative renal scintigraphy was prescribed. Renal defatting and hilum isolation were required in both study arms; in the on-clamp arm, ischaemia was imposed until the completion of medullary renorraphy, while in the off-clamp condition it was not allowed throughout the procedure. The primary endpoint was 6-month absolute variation in estimated glomerular filtration rate (AV-GFR); secondary endpoints were: 12, 18 and 24-month AV-GFR; 6-month estimated glomerular filtration rate variation >25% rate (RV-GFR >25); and absolute variation in ipsilateral split renal function (AV-SRF). The planned sample size was 102 + 102 cases, after taking account crossover of cases to the alternate study arm; a 1:1 randomization was performed. AV-GFR and AV-SRF were compared using analysis of covariation, and RV-GFR >25 was assessed using multivariable logistic regression. Intention-to-treat (ITT) and per-protocol analyses (PP) were performed. RESULTS: A total of 160 and 164 patients were randomly assigned to on- and off-clamp RAPN, respectively; crossover was observed in 14% and 43% of the on- and off-clamp arms, respectively. We were unable to find any statistically significant difference between on- vs off-clamp with regard to the primary endpoint (ITT: 6-month AV-GFR -6.2 vs -5.1 mL/min, mean difference 0.2 mL/min, 95% confidence interval [CI] -3.1 to 3.4 [P = 0.8]; PP: 6-month AV-GFR -6.8 vs -4.2 mL/min, mean difference 1.6 mL/min, 95% CI -2.3 to 5.5 [P = 0.7]) or with regard to the secondary endpoints. The median warm ischaemia time was 14 vs 15 min in the ITT analysis and 14 vs 0 min in the PP analysis. CONCLUSION: In patients with regular baseline function and two kidneys, we found no evidence of differences in functional outcomes for on- vs off-clamp RAPN.

Global experience and progress in GreenLight-XPS 180-Watt photoselective vaporization of the prostate.

PURPOSE: To evaluate changes in global perioperative data of GreenLight-XPS 180-Watt photo-selective vaporization of the prostate (GL-XPS) of the Global Greenlight Group (GGG) database. METHODS: 3441 men, who underwent GL-XPS for symptomatic BPH between 2011 and 2019 at seven high volume international centers, were included. Primary outcome measurements were operative time (OT; min), effective laser time (LT; min of OT), as well as intraoperative and postoperative adverse events (AEs), all analyzed by year of surgery (2011-2019) and prostate volume (PV) group (< 80 ml vs. 80-150 ml vs. > 150 ml). RESULTS: The median age was 70 years (interquartile range 64-77), the median PV was 64 ml (IQR 47-90). The OT and LT slightly increased but stayed highly efficient all in all. Median OT was 60 min (IQR 45-83) and LT was 33 min (IQR 23-46). Median energy use was 253 kJ (IQR 170-375) with an energy density of 3.94 kJ/ml (IQR 2.94-5.02). The relative probability of perioperative AEs decreased by 17% each year (p < 0.001). The relative probability of perioperative transfusion dropped significantly from 2% in 2011 to 0% in 2019 (p = 0.007). The early postoperative complications (within 30 days after surgery) decreased significantly from 48.8% (n = 106) in 2011 to 24.7% (n = 20) in 2019 (p > 0.001). CONCLUSION: These findings from the GGG demonstrate significant improvement secondary to growing experience with GL-XPS between 2011 and 2019 in intraoperative AEs, including transfusions, and postoperative AEs. While staying highly efficient in OT and LT of GL-XPS within a 9-year period of experience.

Simultaneous robotic partial nephrectomy for bilateral renal masses.

PURPOSE: There is currently no consensus regarding the optimal treatment strategy for patients presenting with synchronous bilateral renal masses. The decision to perform bilateral procedures on the same intervention or in staged procedures is debated. The aim of this manuscript is to analyse the outcomes of simultaneous robot-assisted partial nephrectomy (RAPN) in a series of patients with bilateral renal masses treated at five Italian robotic institutions. METHODS: Data from a prospectively maintained multi-institutional database on patients subjected to simultaneous RAPN between November 2011 and July 2019 were reviewed. RAPNs were performed with da Vinci Si or Xi surgical system by expert robotic surgeons. Baseline demographics and clinical features, peri- and post-operative data were collected. RESULTS: Overall, 27 patients underwent simultaneous bilateral RAPN, and 54 RAPNs were performed without need of conversion; median operative time was 250 minutes, median estimated blood loss was 200 mL. Renal artery clamping was needed for 27 (50%) RAPNs with a median warm ischemia time of 15 minutes and no case of acute kidney injury. Complications were reported in 7 (25.9%) patients, mainly represented by Clavien 2 events (6 blood transfusions). Positive surgical margins were assessed in 2 (3.7%) of the renal cell carcinoma. At the median follow-up of 30 months, recurrence-free survival was 100%. CONCLUSION: Our data showed that, in selected patients and expert hands, simultaneous bilateral RAPNs could be a safe and feasible procedure with promising results for the treatment of bilateral synchronous renal masses.

GreenLight photovaporization of the prostate in high-medical-risk patients: an analysis of the Global GreenLight Group (GGG) database.

PURPOSE: We sought to characterize the adjusted outcomes of GreenLight photoselective vaporization of the prostate (PVP) in high-medical-risk (HMR) patients using data from the largest international database. METHODS: Data were obtained from the Global GreenLight Group (GGG) database which pools data of eight high-volume, experienced surgeons, from a total of seven international centers. Eligible study participants underwent GreenLight PVP using the XPS-180 W system between 2011 and 2019. HMR patients were defined as patients with ASA III or greater and were compared to non-HMR patients. Analyses were adjusted for patient age and prostate volume. RESULTS: In the HMR group, patients on average were older and had smaller prostates than the non-HMR control group. Compared to non-HMR patients, transfusions occurred more frequently (2.6% vs. 0.14%, p < 0.01) and the odds of readmission were elevated [OR 2.0, (95% CI 1.4-2.8, p < 0.01)] among HMR patients. Twelve months postoperatively, HMR patients experience greater improvement in QoL than the control group [+ 0.54 (95% CI 0.07-1.0, p = 0.02)]. PVR also decreased 93.1 ml more in HMR than in non-HMR patients after 12 months (95% CI 33.6-152.6, p < 0.01). CONCLUSION: We found that GreenLight PVP is safe and effective in improving functional outcomes in higher-risk patients with severe systemic disease compared to their lower-risk counterparts. Though absolute risks remain low, GreenLight PVP is associated with higher odds of transfusion and readmission in the high-risk cohort. The findings of our study reaffirm current guidelines that propose PVP as a viable treatment option for HMR patients.

Shockwave Therapy for Erectile Dysfunction: Which Gives the Best Results? A Retrospective National, Multi-Institutional Comparative Study of Different Shockwave Technologies.

BACKGROUND: Low-intensity shockwave therapy (Li-SWT) is a promising option for the treatment of erectile dysfunction (ED). Many devices with different characteristics in terms of generators, shockwaves, set-up parameters and procedure protocols are commercially available. In this report, we present our experience with the main shockwave technologies currently in use in clinical practice for ED treatment. METHODS: A retrospective national, multi-institutional study was performed to compare the effects of different shockwave technologies in ED patients. All of the subjects underwent 8 consecutive weekly physical treatments with SWT under either a focused or non-focused regimen: 3,000 shocks per session at 0.09 mJ/mm2 and 10,000 shocks per session at 15 Hz and 90 mJ, respectively. Efficacy was evaluated by comparing pre- and post-treatment Sexual Health Inventory in Men (SHIM) scores, International Index of Erectile Function (IIEF-5) and Erection Hardness Score (EHS). Possible relationships between type of shockwave generator, source, morphology and type of ED were investigated. RESULTS: A total of 94 men were included in the analysis. There were no significant differences in the baseline clinical characteristics or demographics. The mean (SD) increase in the scores from questionnaires evaluated at 8 weeks was clinically and statistically significant, with overall improvements of +5.49, +5.47 and +1.18 (p<0.0001) in the IIEF-5, SHIM, and EHS scores, respectively. The increases in these scores were evaluated by a multiple regression analysis, in relation to the shockwave generator, type of ED, shockwave source and morphology, but none of the factors examined predicted improvement. No side effects were reported with any device. CONCLUSIONS: SWT is a clinically effective and safe treatment for ED that is independent of the generator type, source, shockwave morphology emitted, type of ED and perhaps treatment protocol.

Protocol of the Italian Radical Cystectomy Registry (RIC): a non-randomized, 24-month, multicenter study comparing robotic-assisted, laparoscopic, and open surgery for radical cystectomy in bladder cancer.

BACKGROUND: Bladder cancer is the ninth most common type of cancer worldwide. In the past, radical cystectomy via open surgery has been considered the gold-standard treatment for muscle invasive bladder cancer. However, in recent years there has been a progressive increase in the use of robot-assisted laparoscopic radical cystectomy. The aim of the current project is to investigate the surgical, oncological, and functional outcomes of patients with bladder cancer who undergo radical cystectomy comparing three different surgical techniques (robotic-assisted, laparoscopic, and open surgery). Pre-, peri- and post-operative factors will be examined, and participants will be followed for a period of up to 24 months to identify risks of mortality, oncological outcomes, hospital readmission, sexual performance, and continence. METHODS: We describe a protocol for an observational, prospective, multicenter, cohort study to assess patients affected by bladder neoplasms undergoing radical cystectomy and urinary diversion. The Italian Radical Cystectomy Registry is an electronic registry to prospectively collect the data of patients undergoing radical cystectomy conducted with any technique (open, laparoscopic, robotic-assisted). Twenty-eight urology departments across Italy will provide data for the study, with the recruitment phase between 1st January 2017-31st October 2020. Information is collected from the patients at the moment of surgical intervention and during follow-up (3, 6, 12, and 24 months after radical cystectomy). Peri-operative variables include surgery time, type of urinary diversion, conversion to open surgery, bleeding, nerve sparing and lymphadenectomy. Follow-up data collection includes histological information (e.g., post-op staging, grading, and tumor histology), short- and long-term outcomes (e.g., mortality, post-op complications, hospital readmission, sexual potency, continence etc). DISCUSSION: The current protocol aims to contribute additional data to the field concerning the short- and long-term outcomes of three different radical cystectomy surgical techniques for patients with bladder cancer, including open, laparoscopic, and robot-assisted. This is a comparative-effectiveness trial that takes into account a complex range of factors and decision making by both physicians and patients that affect their choice of surgical technique. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04228198 . Registered 14th January 2020- Retrospectively registered.

The dramatic COVID 19 outbreak in Italy is responsible of a huge drop of urological surgical activity: a multicenter observational study.

OBJECTIVE: To describe the trend in surgical volume in urology in Italy during the coronavirus disease 2019 (COVID-19) outbreak, as a result of the abrupt reorganisation of the Italian national health system to augment care provision to symptomatic patients with COVID-19. METHODS: A total of 33 urological units with physicians affiliated to the AGILE consortium (Italian Group for Advanced Laparo-Endoscopic Surgery; www.agilegroup.it) were surveyed. Urologists were asked to report the amount of surgical elective procedures week-by-week, from the beginning of the emergency to the following month. RESULTS: The 33 hospitals involved in the study account overall for 22 945 beds and are distributed in 13/20 Italian regions. Before the outbreak, the involved urology units performed overall 1213 procedures/week, half of which were oncological. A month later, the number of surgeries had declined by 78%. Lombardy, the first region with positive COVID-19 cases, experienced a 94% reduction. The decrease in oncological and non-oncological surgical activity was 35.9% and 89%, respectively. The trend of the decline showed a delay of roughly 2 weeks for the other regions. CONCLUSION: Italy, a country with a high fatality rate from COVID-19, experienced a sudden decline in surgical activity. This decline was inversely related to the increase in COVID-19 care, with potential harm particularly in the oncological field. The Italian experience may be helpful for future surgical pre-planning in other countries not so drastically affected by the disease to date.

Impact of the presence of a median lobe on functional outcomes of greenlight photovaporization of the prostate (PVP): an analysis of the Global Greenlight Group (GGG) Database.

OBJECTIVES: Previous analyses of the impact of median lobe presence on Greenlight photoselective vaporization of the prostate (PVP) outcomes were limited by their small sample size and the ability to adjust for important confounders. As such, we sought to investigate the impact of prostate median lobe presence on the operative outcomes of 180 W XPS GreenLight PVP using a large international database. METHODS: Data were obtained from the Global GreenLight Group (GGG) database which pools data of eight high-volume, experienced surgeons, from a total of seven international centers. All men with established benign prostatic hyperplasia who underwent GreenLight PVP using the XPS-180 W system between 2011 and 2019 were eligible for the study. Patients were assigned to two groups based on presence or absence of median lobes. Analyses were adjusted for patient age, prostate volume, body mass index, and American Society of Anesthesia (ASA) score. RESULTS: A total of 1650 men met the inclusion criteria. A median lobe was identified in 621 (37.6%) patients. Baseline prostate volume, patient age, and ASA score varied considerably between the two groups. In adjusted analyses, the operative and lasing time of patients with median lobes was 6.72 (95% CI 3.22-10.23; p < 0.01) minutes and 2.90 (95% CI 1.02-4.78; p < 0.01) minutes longer than the control group. Men with median lobes had similar postoperative functional outcomes to those without a median lobe except for a 1.59-point greater drop in the 12-month IPSS score compared to baseline (95% CI 0.11-3.08; p = 0.04) in the median lobe group, and a decrease in PVR after 6 months which was 46.51 ml (95% CI 4.65-88.36; p = 0.03) greater in patients with median lobes compared to men without median lobes. CONCLUSIONS: Our findings suggest that the presence of a median lobe has no clinically significant impact on procedural or postoperative outcomes for patients undergoing Greenlight PVP using the XPS-180 W system.

Global Greenlight Group: largest international Greenlight experience for benign prostatic hyperplasia to assess efficacy and safety.

INTRODUCTION: Greenlight photo-selective vaporization of the prostate (GL-PVP) has gained international acceptance as a safe and effective alternative procedure for the treatment of benign prostatic hyperplasia (BPH), especially in anticoagulated men. This descriptive analysis aims to characterize the current state of GL-PVP, pooling data from international centers. METHODS: Data from 3627 patients who underwent GL-PVP with the XPS-180 W system in seven international centers performed by eight expert surgeons between 2011 and 2019 were retrospectively analyzed. Demographic, perioperative, and postoperative data were collected, including IPSS, QoL, Qmax, PVR, and PSA, and complications. RESULTS: At baseline, median age, prostate volume, PSA, and IPSS were 70 years (interquartile range 64-77), 64 (47-90), 3.1 ng/mL (1.8-6), and 22 (19-27), respectively. Median lasing and operative time were 34 (23-48) and 62 min (46-85), respectively. Median energy use was 250.0 kJ (168.4-367.9), with 92.6% of procedures being completed with one laser fiber. In 60.1% of cases, catheter was removed on postoperative day 1 with median length of 2 days. All-cause mortality within 30 days was 0.3%. Median PSA reduction at 3 months and 60 months compared to baseline was 43.9 and 46.4%, respectively (p < 0.001). All functional outcomes (IPSS, QoL, Qmax, and PVR) were significantly improved across study period when compared to baseline (p < 0.001). For those men with longer follow-up available, the observed surgical BPH retreatment rate was 1.5% CONCLUSION: Using the largest multi-user, international database of GL-PVP, Greenlight XPS laser treatment in experienced hands is a safe, effective, and durable BPH treatment option.

A National Multicenter Study on overall survival in elderly metastatic castrate-resistant prostate cancer patients treated with Radium-223.

BACKGROUND: Radium-223 prolongs overall survival (OS) and delays time to the first symptomatic skeletal events in patients with symptomatic metastatic castration-resistant prostate cancer (mCRPC). There is a lack of evidence on the safety and efficacy of Radium-223 treatment in the very elderly population. AIMS: Aim of this multicentre study is to analyze mCRPC patients treated with Radium-223 in terms of OS and to assess whether there are differences between young and elderly, as well as to verify efficacy and safety in patients ≥ 75 years of age. METHODS: 430 mCRPC patients of six Italian Centres were analyzed in this multicenter retrospective study. At baseline and after each cycle were collected clinical and diagnostic patients' parameters. The whole cohort was divided into two groups based on the age of the patients (< 75 years old and ≥ 75 years old). RESULTS: 47% of the patients were < 75 years old and 53% were ≥ 75 years old. The primary outcome, OS, does not show significant differences between the two subgroups if other basal parameters are considered. Considering clinical covariates in univariate models (p < 0.05) several clinical aspects have an impact on OS, except for age (p = 0.072). Age continues to have no significant impact on the OS (p = 0.274) even in multivariate models in the two groups. The toxic effects are similar in the two groups. CONCLUSIONS: Radium-223 prolongs survival in both younger and older patients at the same baseline condition and is a good option in the symptomatic mCRPC setting compared to other agents.

New Antiandrogen Compounds Compared to Docetaxel for Metastatic Hormone Sensitive Prostate Cancer: Results from a Network Meta-Analysis.

PURPOSE: Docetaxel represent the standard of care in patients with metastatic, hormone sensitive prostate cancer. However, androgen receptor axis targeted therapies have also been shown to be effective. We aimed to analyze findings in randomized controlled trials investigating first-line treatment for hormone sensitive prostate cancer. MATERIALS AND METHODS: We systematically reviewed the literature according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) criteria and the PICO (Population, Intervention, Comparator, Outcomes) methodology. Outcomes of interest were overall and progression-free survival, and the rate of high grade adverse events. RESULTS: No treatment was superior to docetaxel in terms of overall survival. However, abiraterone (HR 0.89, 95% CI 0.76-1.05), enzalutamide (HR 0.90, 95% CI 0.69-1.19) and apalutamide (HR 0.90, 95% CI 0.67-1.22) showed nonstatistically significant lower overall mortality rates than docetaxel. Abiraterone (HR 0.71, 95% CI 0.59-0.86), enzalutamide (HR 0.61, 95% CI 0.49-0.75) and apalutamide (HR 0.74, 95% CI 0.57-0.95) also showed statistically significant lower disease progression rates than docetaxel. Furthermore, abiraterone (OR 0.83, 95% CI 0.56-1.21) showed no statistically significant lower rate of high grade adverse events compared to docetaxel. Finally, enzalutamide (OR 0.56, 95% CI 0.35-0.92) and apalutamide (OR 0.44, 95% CI 0.24-0.79) showed statistically significant lower rates of high grade adverse events compared to docetaxel. CONCLUSIONS: Treatment with androgen receptor axis targeted therapies combined with androgen deprivation therapy in patients with hormone sensitive prostate cancer did not offer a statistically significant advantage in overall survival compared to the standard, docetaxel. However, it was associated with a lower disease progression rate. Moreover, apalutamide and enzalutamide offer a better safety profile.