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.

Risk of unfavorable outcomes after penile prosthesis implantation - results from a national registry (INSIST-ED).

Like all surgeries, penile prosthesis implantation (PPI) has the potential for both postoperative complications and suboptimal patient satisfaction. In order to assess risk factors for poor satisfaction, we reviewed patients who had been prospectively recruited in a national multi-institutional registry of penile prostheses procedures (INSIST-ED) from 2014 to 20121. Patient baseline characteristics and postoperative complications were recorded. The primary endpoint of this study was unfavorable outcomes after inflatable PPI, defined as significant postoperative complications (Clavien-Dindo ≥2) and/or Sexuality with Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) scores below the 10th percentile. A total of 256 patients were included in the study. The median age was 60 years (IQR 56-67). The most common cause of erectile dysfunction (ED) was organic (42.2%), followed by pelvic surgery/radiotherapy (39.8%) and Peyronie's disease (18.0%). Postoperative complications were recorded in 9.6%. High-grade complications (Clavien ≥2) occurred in 4.7%. At 1-year follow-up, the median QoLSPP total score was 71 (IQR 65-76). In all, 14.8% of patients were classified as having experienced unfavorable outcomes because of significant postoperative complications and/or QoLSPP scores below the 10th percentile. Logistic regression analysis demonstrated patient age to be non-linearly associated with the risk of experiencing unfavorable outcomes. A U-shaped correlation showed a lower risk for younger and older patients and a higher risk for middle-aged men. ED etiology and surgical volume were not associated with PPI outcomes. Physicians should, therefore, be aware that middle-aged men may be at higher risk of being unsatisfied following PPI compared to both younger and older patients.

Patient and Context Factors in the Adoption of Active Surveillance for Low-Risk Prostate Cancer.

Importance: Although active surveillance for patients with low-risk prostate cancer (LRPC) has been recommended for years, its adoption at the population level is often limited. Objective: To make active surveillance available for patients with LRPC using a research framework and to compare patient characteristics and clinical outcomes between those who receive active surveillance vs radical treatments at diagnosis. Design, Setting, and Participants: This population-based, prospective cohort study was designed by a large multidisciplinary group of specialists and patients' representatives. The study was conducted within all 18 urology centers and 7 radiation oncology centers in the Piemonte and Valle d'Aosta Regional Oncology Network in Northwest Italy (approximate population, 4.5 million). Participants included patients with a new diagnosis of LRPC from June 2015 to December 2021. Data were analyzed from January to May 2023. Exposure: At diagnosis, all patients were informed of the available treatment options by the urologist and received an information leaflet describing the benefits and risks of active surveillance compared with active treatments, either radical prostatectomy (RP) or radiation treatment (RT). Patients choosing active surveillance were actively monitored with regular prostate-specific antigen testing, clinical examinations, and a rebiopsy at 12 months. Main Outcomes and Measures: Outcomes of interest were proportion of patients choosing active surveillance or radical treatments, overall survival, and, for patients in active surveillance, treatment-free survival. Comparisons were analyzed with multivariable logistic or Cox models, considering centers as clusters. Results: A total of 852 male patients (median [IQR] age, 70 [64-74] years) were included, and 706 patients (82.9%) chose active surveillance, with an increasing trend over time; 109 patients (12.8%) chose RP, and 37 patients (4.3%) chose RT. Median (IQR) follow-up was 57 (41-76) months. Worse prostate cancer prognostic factors were negatively associated with choosing active surveillance (eg, stage T2a vs T1c: odds ratio [OR], 0.51; 95% CI, 0.28-0.93), while patients who were older (eg, age ≥75 vs <65 years: OR, 4.27; 95% CI, 1.98-9.22), had higher comorbidity (Charlson Comorbidity Index ≥2 vs 0: OR, 1.98; 95% CI, 1.02-3.85), underwent an independent revision of the first prostate biopsy (OR, 2.35; 95% CI, 1.26-4.38) or underwent a multidisciplinary assessment (OR, 2.65; 95% CI, 1.38-5.11) were more likely to choose active surveillance vs active treatment. After adjustment, center at which a patient was treated continued to be an important factor in the choice of treatment (intraclass correlation coefficient, 18.6%). No differences were detected in overall survival between active treatment and active surveillance. Treatment-free survival in the active surveillance cohort was 59.0% (95% CI, 54.8%-62.9%) at 24 months, 54.5% (95% CI, 50.2%-58.6%) at 36 months, and 47.0% (95% CI, 42.2%-51.7%) at 48 months. Conclusions and Relevance: In this population-based cohort study of patients with LRPC, a research framework at system level as well as favorable prognostic factors, a multidisciplinary approach, and an independent review of the first prostate biopsy at patient-level were positively associated with high uptake of active surveillance, a practice largely underused before this study.

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.

One-year outcomes after water vapor thermal therapy for symptomatic benign prostatic hyperplasia in an unselected Italian multicenter cohort.

BACKGROUND: Water vapor therapy (Rezum®; Boston Scientific, Marlborough, MA, USA) for bladder outflow obstruction (BOO) due to benign prostatic enlargement (BPE) is a minimally invasive and innovative surgical technique. The aim of this study was to evaluate its mid-term results in a large multicentric cohort of Italian patients. METHODS: Patients with BPO and moderate to severe LUTS who underwent Rezum® (Boston Scientific) treatment from May 2019 to July 2021 were included in this study. Pre- and postoperative evaluation comprised full urological evaluation with urine culture, digital rectal examination, serum PSA, transrectal prostate ultrasound, uroflowmetry, post-void residual and IPSS, OAB-q SF, ICIQ-UI SF and IIEF-5, ejaculatory anterograde rate. Minimum follow-up was 12 months. Patients' subjective satisfaction was recorded with Patient Global Impression of Improvement (PGI-I) Scale together with any early or late reported complications, classified according to Clavien-Dindo Scale. Statistical analysis was conducted as appropriate. RESULTS: Overall, 352 patients were eligible for the analysis. Procedures were routinely done on an outpatient basis. Mean operative was 12 minutes. The catheter was left in place for a median of 7 days. After treatment, Qmax, IPSS and IPSS-QoL, OAB-q SF, ICIQ-UI SF and IIEF-5 from baseline to last control follow-up (median 16, IQR 13-20 months) were improved (P<0.05). The postoperative anterograde ejaculation rate was recorded in 74.1% vs. preoperative 43.8% (P<0.001). Early (≤30 days) postoperative complications occurred in 176 patients (50%), all Clavien-Dindo Grade ≤2. One patient experienced clot retention and hematuria requiring hospitalization and blood transfusion. No late AEs were recorded. Surgical retreatment rate was 2.5% (9/352), all cases occurred within the first year. Median PGI-I was 2 (1-2). CONCLUSIONS: We confirmed the safety and efficacy of water vapor therapy for the treatment of symptomatic benign prostatic obstruction (BPO) on a large cohort of patients. Anterograde ejaculation was preserved in the majority of patients, with good subjective improvement. Further studies may rule out possible role of Rezum® (Boston Scientific) in new patients' setting.

Do Patients Treated with Water Vapor Therapy and Meeting Randomized Clinical Trial Criteria Have Better Urinary and Sexual Outcomes Than an Unselected Cohort?

Introduction: Water vapor intraprostatic injection (Rezum procedure) for benign prostatic hyperplasia (BPH) is one of the most promising minimally invasive surgical treatments. Five-year outcomes from the multicenter randomized controlled trial (RCT) demonstrated significant and durable urinary and sexual function results in selected patients. We compared the sexual and urinary outcomes of this procedure in patients satisfying inclusion criteria of the RCT with unselected patients. Materials and Methods: We prospectively followed all patients with symptomatic BPH who underwent Rezum therapy at eight institutions and analyzed the functional results. Patients were divided into two groups: patients who matched the 5-year RCT inclusion criteria (Group A) and patients who did not (Group B). The pre- and postoperative data, complications, presence of antegrade ejaculation, and urinary and sexual outcomes were periodically recorded. Results: A total of 426 patients were eligible for the study (232 in Group A and 194 in Group B). Patients in Group B had a higher American Society of Anesthesiologists score, prostate volume, and postvoid residual measurement. No difference was found in terms of preoperative International Prostate Symptom Score, International Index of Erectile Function, maximum urinary flow, and prostate-specific antigen. Longer operative time and higher number of vapor injections were required in Group B, with no differences in hospital stay, injection density, and complication rates. All the urinary and sexual outcomes improved with no differences between the two groups. The reintervention rate at the latest follow-up visit was 2.6% in Group A and 3.1% in Group B. Conclusions: In our large multicenter series, water vapor intraprostatic injections showed a safe and effective profile regardless of the prostate size, presence of indwelling catheter, antiplatelet/anticoagulant medications, and patients' comorbidities.

Composite urinary and sexual outcomes after Rezum: an analysis of predictive factors from an Italian multi-centric study.

BACKGROUND: The Rezum system is one of the latest minimally invasive surgical treatments for benign prostatic hyperplasia. METHODS: We retrospectively reviewed all patients who underwent the Rezum treatment in seven different Italian institutions. A successful urinary outcome was defined as: ≥50% improvement in the IPSS <7, improvement in peak flow ≥50% and/or more than 15 ml/s, ≥1-point improvement in the QoL questionnaire and in the absence of perioperative major complications (AUR, transfusion) or postoperative incontinence. A successful sexual outcome was defined as postoperative (latest follow up consultation) antegrade ejaculation or no variation in ejaculatory function and an increase, or stability or max 1 class reduction, in IIEF-5. RESULTS: 262 patients were enrolled with a follow-up period of 11 months (IQR 5-15). No early or late serious adverse events (Clavien III-IV) occurred. Early complications occurred in 39.3% of cases, with 4 cases of clot retention and one case of blood transfusion. Urge incontinence was reported by 6 patients (2.2%). A treatment failure requiring re-intervention occurred in 4 cases (1.5%). The preoperative antegrade ejaculation rate was 56.5%, and after the procedure it increased to 78.2%. The increase of ≥1-point in the QoL was achieved in 92.7% of the cases. Optimal urinary and sexual outcomes were achieved in 52.9% and 87.8%, respectively. CONCLUSIONS: In our series, water vapor intraprostatic injections seem to be an effective and safe procedure.

Which patient may benefit the most from penile prosthesis implantation?

BACKGROUND: Penile prosthesis implantation has been associated with overall good functional outcomes. Of relevance, some patients reported higher level of satisfaction and quality of life. AIM: We investigated the profile of the patients who may benefit the most from penile prosthesis implantation. MATERIALS AND METHODS: Data from a national multi-institutional registry of penile prostheses including patients treated from 2014 to 2017 in Italy (Italian Nationwide Systematic Inventarization of Surgical Treatment for Erectile Dysfunction) were analyzed. All data have been prospectively recorded by 45 surgeons on a dedicated website (www.registro.andrologiaitaliana.it) and revised by a single data manager. Patients' baseline characteristics were recorded. In order to simultaneously evaluate perceived penile prosthesis function and quality of life, all patients were re-assessed at 1-year follow-up using the validated questionnaire Quality of Life and Sexuality with Penile Prosthesis. High quality of life after surgery was defined as a score higher than the 75th percentile in each of the subdomains of the Quality of Life and Sexuality with Penile Prosthesis questionnaire. Logistic regression analysis tested the association between clinical characteristics and high quality of life after penile prosthesis implantation. RESULTS: Follow-up data were available for 285 patients (median age 60 years; interquartile range: 56-67) who underwent penile prosthesis implantation. Erectile dysfunction etiology was organic in 40% (114), pelvic surgery/radiotherapy in 39% (111), and Peyronie's disease in 21% (60) of the cases. Patients showed good overall Quality of Life and Sexuality with Penile Prosthesis scores at 1-year follow-up for functional (22/25), personal (13/15), relational (17/20), and social (13/15) domains. Overall, 27.0% (77) of patients achieved scores consistent with the high quality of life definition. These patients did not differ in terms of median age (60 vs. 62), type of prosthesis (inflatable penile prostheses: 95% in both of the cases), and post-operative complications (10% vs. 14%) than those with lower quality of life score (all p > 0.1). At logistic regression analysis, erectile dysfunction etiology was the only factor independently associated with high quality of life at 1 year after surgery (p = 0.02). Patients treated for Peyronie's disease (odds ratio: 2.62; p = 0.01; 95% confidence interval: 1.20-5.74) were more likely to report better outcomes after accounting for age, post-operative complications, and surgical volume. CONCLUSION: Penile prosthesis implantation is associated with an overall good quality of life. The subset of patients affected by erectile dysfunction secondary to Peyronie's disease seemed to benefit the most from penile prosthesis implantation in terms of functional outcomes, relationship with their partners and the outside world, and perceived self-image. The systematic use of validated questionnaires specifically addressed at evaluating quality of life and satisfaction after penile prosthesis implantation should be further implemented in future studies to better define the predictors of optimal satisfaction after penile prosthesis implantation.

Post-Operative Acute Urinary Retention After Greenlight Laser. Analysis of Risk Factors from A Multicentric Database.

PURPOSE: Greenlight laser is a mini-invasive technique used to treat Benign Prostatic Obstruction (BPO). Some of the advantages of GreenLight photoselective vaporization (PVP) are shorter catheterization time and hospital stay compared to TURP. Post-operative acute urinary retention (pAUR) leads to patients' discomfort, prolonged hospital stay and increased health care costs. We analyzed risk factors for urinary retention after GreenLight laser PVP. MATERIALS AND METHODS: In a multicenter experience, we retrospectively analyzed the onset of early and late post-operative acute urinary retention in patients undergoing standard or anatomical PVP. The pre-, intra- and post-operative characteristics were compared betweene patients who started to void and the patients who developed post-operative urinary retention. RESULTS: The study included 434 patients suitable for the study. Post-operative acute urinary retention occurred in 39 (9%). Patients with a lower prostate volume (P < .001), an adenoma volume lower than 40 mL (P < .001), and lower lasing time (P = .013) had a higher probability to develop pAUR at the univariate analysis. The multivariate logistic regression confirmed that lower lasing time (95% CI: 0.86-0.99, OR = 0.93, P = .046) and adenoma volume (95% CI: 0.89-0.98, OR = 0.94, P = .006) are correlated to pAUR. Furthermore IPSS ≥ 19 (95% CI: 1.19- 10.75, OR = 2.27, P = .023) and treatment with 5-ARI (95% CI: 1.05-15.03, OR = 3.98, P = .042) are risk factors for pAUR. CONCLUSION: In our series, post-operative acute urinary retention was related to low adenoma volume and lasing time, pre-operative IPSS ≥ 19 and 5-ARI intake. These data should be considered in deciding the best timing for urethral catheters removal.

The safety and feasibility of the simultaneous use of 180-W GreenLight laser for prostate vaporization during concomitant surgery.

OBJECTIVES: To explore the safety and feasibility of photo-selective vaporization of the prostate (PVP) with GreenLight XPS 180 Watt laser (GL-180- W XPS) combined with other surgical procedures. MATERIAL AND METHODS: Data on patients in whom GL-180-W XPS was performed to relieve lower urinary tract symptoms/ benign prostatic hyperplasia (LUTS/BPH) symptoms were extracted from a multi-institutional database (2011-2016). Patients were stratified into two groups. In the first all patients who had GL-180-W XPS with a concomitant procedure during the same surgical session were included as cases while those who underwent GL-180-W XPS PVP only were included as control. RESULTS: A total of 487 patients were included. Fifty-eight (11.9%) patients underwent concomitant procedures. Multivariable linear regression models failed to find an association between concomitant procedures and longer laser time (p = 0.4). Similarly, multivariable linear regression models failed to find an association between concomitant procedures and laser time even when the analyses were repeated and stratified into endoscopic (p = 0.6) and open/laparoscopic (p = 0.4) procedures. Multivariable logistic regression models failed to demonstrate any association between concomitant procedures and early complications (OR:1.39, CI: 0.379-2.44, p = 0.2), late complications (OR:1.84, CI:0.78-3.98; p = 0.1) and acute urinary retention (OR:1.84, CI:0.78-3.98; p = 0.1). When the analyses were repeated and the concomitant procedures stratified into endoscopic and open/laparoscopic ones, they yielded virtually the same results. CONCLUSIONS: GL-180-W XPS PVP could be safely performed in concomitant endoscopic or open/laparoscopic surgery. These results should be taken into consideration in the counseling of the patient who might choose to undergo simultaneous procedures.

Operative profile, safety and functional outcomes after GreenLight laser prostate surgery: results from a 12 months follow-up multicenter Italian cohort analyses.

BACKGROUND: Over the two past decades, GreenLight laser therapy has been considered a valid alternative for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia/benign prostatic obstruction (BPH/BPO). However, the debate on the effectiveness of laser therapy compared to conventional techniques is still open. The aim of our study is to analyze and describe the use of GreenLight laser prostate surgery in Italy, with regard to the surgical techniques performed and the surgical and functional outcomes at mid-term follow-up. METHODS: From March 2012 to July 2018, patients who underwent GreenLight laser prostate surgery for LUTS due to BPH/BPO from 19 Italian centers were included. The following parameters were evaluated in the population: age, prostate volume, prostate adenoma volume, PSA tot, Qmax at uroflowmetry (UFM), International Prostatic Symptoms Score (IPSS), previous therapy for LUTS, use of anticoagulants and antiplatelet drugs. We recorded also the kind of anesthesia, mean laser time (min), mean irradiation time (min), TURP conversion/completion rate, postoperative day of catheter removal, postoperative acute urinary retention (AUR), hospital stay, variation of hematocrit (Ht) and hemoglobin levels (Hb). Early complications were classified according to the Clavien-Dindo classification, the re-operation rate within 30 days and after 30 days, the late complications and the Patient Global Impression of Improvement were also collected. Changes over time in terms of blood loss and functional outcomes (IPSS and Qmax at the UFM at 6 and 12 months) were tested with Student's test for paired samples. We assumed P≤0.05 as level of statistical significance. RESULTS: Overall, 1077 were enrolled in the study, 554 (56.4%) were treated with standard vaporization and 523 (48.6%) with anatomical vaporization. Student's t-test for paired samples showed no statistically significant differences in terms of reduction of Ht preoperative vs. Ht postoperative (42.80±3.91 vs. 39.93±5.35 95% CI P=0.3) and preintervention and postintervention Hb levels (14.28±1.46 vs. 13.72 P=0.35). Compared with the preoperative Qmax (8.60±2.64), the 6- and 12-month UFM showed a significant improvement [19.56±6.29, P<0.01 and 19.99±5.92 P<0.01]. In terms of IPSS variation, compared to the baseline level (22±5.51) the 6- and 12-month follow-up confirmed a significant reduction (8.01±4.41 P<0.01 and 5.81±4.12 P<0.01 respectively). Postoperative complications were CD0, CD1, CD2, CD3, CD4 in 33.0%,35.3%, 2.9%, 0.3%, and 0.6%. CONCLUSIONS: To the best of our knowledge, this is one of the most numerous surgical series of GreenLight laser vaporization and with the longest follow-up. This technique should be considered as a safe and effective alternative in the treatment of secondary LUTS to BPH.

GreenLight Photoselective Vaporization of the Prostate: One Laser for Different Prostate Sizes.

Introduction: GreenLight laser vaporization of the prostate (photoselective vaporization of the prostate [PVP]) is a safe and effective procedure for Benign Prostatic Hyperplasia. Long-term results and advantages of PVP in patients with large and symptomatic prostate are still under evaluation. Materials and Methods: In a multicenter experience, patients who underwent standard or anatomical PVP were retrospectively reviewed. Patients with follow-up >12 months were divided into two groups based on prostate volume (<100 cc vs ≥100 cc). Pre- and perioperative data, as well as postoperative results and complications, were recorded after 3, 6, and 12 months and then annually. Results: One thousand and thirty-one patients were eligible, 916 of these had a prostate volume of <100 cc and 115 ≥ 100 cc. Median follow-up period was 25.0 months (interquartile range [IQR] 16.5-35.0) and 16.0 months (IQR 12.0-24.0) in ≥100 and <100 groups, respectively. No difference was found in terms of catheterization time, postoperative stay, and postoperative acute urine retention. Patients with prostate ≥100 required longer operative time (75 vs 55 minutes), lasing time (41.7 vs 24.9 minutes), and higher energy used but lower energy density. Patients with prostate ≥100 had a higher incidence of early (50.4% vs 35.7%) and late complications (21.7% vs 12.8%) and early urge/incontinence symptoms (40.9% vs 29.3%). No statistically significant differences were found for the maximum urinary flow (Qmax) and International Prostate Symptom Score (IPSS) results between the two groups. The reintervention rate in ≥100 group was 3.5% vs 2.3% in <100. Conclusions: In the midterm follow-up, GreenLight PVP guarantees the same results in different prostate volume groups. Early and late complications are more frequent in large prostates.

Perioperative major acute cardiovascular events after 180-W GreenLight laser photoselective vaporization of the prostate.

BACKGROUND: Major acute cardiovascular events (MACE) prevalence after 180-W GreenLight (180-W GL) laser photoselective vaporization (PVP) have never been explored. Aim of our study is to evaluate perioperative MACE that occurred concomitantly with 180-W GL PVP. MATERIALS AND METHODS: We relied on a multi-institutional database that included 14 centers. Data from 923 patients who underwent 180-W GL PVP were reviewed. We abstracted pre- and perioperative data of patients who experienced perioperative MACE, such as angina pectoris, acute myocardial infarction, other chronic ischemic heart disease, transient ischemic attack, or cerebrovascular accident as well as deep venous thrombosis with or without pulmonary embolism. We relied on a case-series format to report the main findings of our analyses. RESULTS: 18 (1.9%) patients reported MACE in 7 centers. Median age was 69.5 (IQR 66.0-79.2) years. Of all, 7 patients underwent standard PVP and 11 anatomical PVP. Eleven patients (61.1%) were not under anticoagulant/antiplatelet treatment, 6 (33.3%) were under low dose aspirin, and 1 (5.6%) was under clopidogrel. Four patients (22.2%) had an instrumental and laboratory diagnosis of myocardial infarction, 7 (38.9%) had an episode of angina pectoris with or without rhythm alteration, 3 (16.7%) reported symptomatic deep venous thrombosis, and 4 (22.2%) had other MACE-like events. CONCLUSIONS: Physician should take in consideration the possibility of MACE or MACE-like events. The real MACE rate may be different as only half of included centers reported MACE. Since the main target of laser surgery are high-risk bleeding patients, prospective observational trials focused on detection of these possible complications are warranted.

Therapeutic ureteral occlusion with Ifabond cyanoacrylate glue: an interesting solution.

OBJECTIVE: The aim of this study was to present a novel approach for complete and permanent ureteral occlusion using a percutaneous injection of Ifabond cyanoacrylate glue. METHODS: We describe in detail all the steps of our surgery, performed on a 79-year-old patient with urinary leakage from ureteral stump following radical cystectomy. N-hexyl-cyanoacrylate glue (Ifabond) was used to occlude the distal ureter and solve the leakage. RESULTS: Our approach was successful, sparing our already frail patient further surgical procedures. Six months pyelography confirmed the complete ureteral blockage with absence of extravasation. CONCLUSIONS: In complicated scenarios with urinary leakages and frail patients, synthetic glues such as Ifabond might represent an interesting therapeutic option to solve the fistulas, leading to durable success with a minimally invasive approach.

INSIST-ED: Italian Society of Andrology registry on penile prosthesis surgery. First data analysis.

OBJECTIVES: The Italian Society of Andrology, i.e. "Società Italiana di Andrologia" (S.I.A.), launched on December 2014 a prospective, multicenter, monitored and internal review board approved Registry for penile implants, the "INSIST-ED" (Italian Nationwide Systematic Inventarisation of Surgical Treatment for ED) Registry. Purpose of this first report is to present a baseline data analysis of the characteristics of penile implant surgery in Italy. MATERIAL AND METHODS: The INSIST-ED Registry is open to all surgeons implanting penile prostheses (all brands, all models) in Italy, providing anonymous patient, device, surgical procedure, outcome, follow-up data, for both first and revision surgeries. A Registry project Board overviews all the steps of the project, and a Registry Monitor interacts with the Registry implanting surgeons. RESULTS: As by April 8, 2016, 31 implanting surgeons actively joined the Registry, entering 367 surgical procedures in its database, that comprise: 310 first implants, 43 prosthesis substitutions, 14 device explants without substitution. Implanted devices account for: 288 three-component devices (81,3%), 20 two-component devices (5,4%), 45 non-hydraulic devices (12,3%). Leading primary ED etiologies in first implant surgeries resulted: former radical pelvic surgery in 111 cases (35,8%), Peyronie's disease in 66 cases (21,3%), diabetes in 39 cases (12,6%). Two intraoperative complications have been recorded. Main reasons for 57 revision surgeries were: device failure (52,6%), erosion (19,3%), infection (12,3%), patient dissatisfaction (10,5%). Surgical settings for patients undergoing a first penile implant were: public hospitals in 251 cases (81%), private environments in 59 cases (19%). CONCLUSIONS: The INSIST-ED Registry represents the first European experience of penile prosthesis Registry. This baseline data analysis shows that: three-pieces inflatable prosthesis is the most implanted device, leading etiology of erectile dysfunction (ED) in patient receiving a prosthesis is former radical pelvic surgery, primary reason for revision surgery is device failure, primary settings for first penile implant surgery are public hospitals. Evaluation of penile implant impact on recipients quality of life is presently ongoing.

[Use of frozen sections to assess surgical margins during radical prostatectomy]. / Impiego dell'esame estemporaneo al congelatore per la valutazione dei margini chirurgici in corso di prostatectomia radicale

INTRODUCTION: At present there is no consensus on the use of frozen sections (FS) during radical prostatectomy. Several groups have proposed the benefit of FS although the studies differ widely in sampling methods and sites where FS were taken. This study aims to evaluate the usefulness and reliability of standard assessment of FS in multiple sites during radical prostatectomy. METHODS: During open radical prostatectomy in all patients we sampled tissue from the urethral stump, the neurovascular bundles, the Denonvillier fascia and the bladder neck after removing the prostate. Where FS showed positive margins, further periprostatic tissue was resected from the prostatic bed until negative margins were achieved. The results of FS were compared with margin status of final pathology. RESULTS: From 1998 to 2004 we performed FS during 250 consecutive open radical prostatectomies (104 nerve sparing procedures). 66 patients had positive FS (26.4%) and 53 patients had positive surgical margins at final pathology (21.2%). All patients with positive FS had negative margins when further tissue was resected in the prostatic bed. During nerve sparing procedures positive FS were found in 14 patients. In these cases the procedure was converted into standard prostatectomy by resecting the neurovascular bundles. Sensibility and specificity were both 90%. Positive and negative predictive values were respectively 72% and 97%. CONCLUSIONS: Standard assessment of FS in multiple sites during radical prostatectomy achieved sensibility and specificity as high as 90%. Although the resection of urethral stump and tissue close to the neurovascular bundles could compromise functional results, standard assessment of FS in multiple sites could help the surgeon to reduce the positive surgical margins, to monitor the oncological safety of a nerve sparing procedure and to improve the pathological staging.

Transmesenteric approach for left transperitoneal renal surgery: technique and experience.

INTRODUCTION: In the last few years laparoscopic surgery has become the gold standard for the treatment of several urological diseases such as renal cancer and ureteropelvic junction obstruction (UPJO). A transmesenteric approach for left laparoscopic pyeloplasty has been recently described in order to avoid bowel manipulation and the potentially related complications. The aim of the present study is to describe the surgical technique and the advantages of the transmesenteric approach for laparoscopic pyeloplasty, pyelolithotomy, and simple nephrectomy in our experience. SUBJECTS AND METHODS: From December 2007 to May 2010, 12 laparoscopic procedures for left renal diseases were performed using a transmesenteric approach. The indications were left UPJO in 9 cases, left pelvic-ureteral stones in 2 cases, and left end-stage kidney disease in one case. RESULTS: No conversions or intraoperative complications were observed. No blood transfusions were required. Resumption of oral intake and canalization occurred in all cases within 48 hours of the procedure. All patients had an uneventful postoperative course. CONCLUSIONS: The laparoscopic transmesenteric approach represents an interesting and advantageous technical improvement of minimally invasive surgery for the treatment of left renal diseases.