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.

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.

Transurethral water vapor therapy for treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia: a cost-minimization and budget impact analysis from an Italian healthcare perspective.

BACKGROUND: The aim of this study was to compare the costs and budget impact of adopting water vapor thermal therapy with the Rezum™ System, for treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) to transurethral resection of the prostate (TURP), from an Italian hospital healthcare perspective. METHODS: A Markov model (4-year time horizon, 3-month cycle length), developed to support a submission to the National Institute of Health and Care Excellence (NICE) in England, was adapted to an Italian payer perspective. A cost minimization analysis was conducted, assuming equal efficacy between both therapies. Net difference in costs per patient was reported, considering procedure, adverse events and retreatment costs. Probabilistic and deterministic sensitivity analyses considered the uncertainty of the results. Population data and market share distribution assumptions were applied to a cohort of Italian patients treated in one year to report the budget and capacity impact of increased use of Rezum. RESULTS: Over 4 years, the costs per patient with Rezum were €2072 compared to €2836 with TURP, resulting in net savings of €764. Sensitivity analyses showed that this conclusion was robust. Replacing 10% of TURP procedures with Rezum generates cost-savings of € 7,139,549 over 4 years and saves 4671 theatre hours and 26,856 bed days in one year. Replacing 30% of BPH surgical procedures with Rezum generates cost-savings to € 21,418,647 over 4 years, saves 14,012 theatre hours and 80,567 bed-days in one year. CONCLUSIONS: This analysis demonstrates that Rezum is highly likely to be cost-saving compared to TURP from an Italian hospital healthcare perspective.

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.

[Transrectal ultrasound assessment of anastomosis after videolaparoscopic radical prostatectomy: our experience]. / Il controllo ecografico transrettale dell'anastomosi dopo VLRP. La nostra esperienza.

BACKGROUND: Trans-Rectal UltraSound (TRUS) has proved to be an accurate procedure comparable to that of Fluoro-cystography (FC) to assess vesicourethral anastomosis after radical prostatectomy, with the advantages of lower costs, no radiation exposure and no dependence on the radiology department. METHODS: 60 Video Laparoscopic Radical Prostactomies (VLRP) were performed at our institution between September 2008 and January 2010. All patients underwent anatomosis assessment on postoperative day 6 with TRUS (Aloka A7 US machine with endorectal end-fire probe). 200 ml of sterile saline was manually instilled into the bladder by an assistant, while TRUS visualization of anastomosis was carried out by an urologist. The test was considered positive if any expanding anechoic shadow developed beside the anastomosis. In case of negative test the catheter was removed. In case of positive test the catheter was left in place and reassessment was performed every 5-7 days with both TRUS and FC, until negative result. RESULTS: At the initial TRUS assessment we had 4 positive and 56 negative tests. Three out of the four patients with a positive test had a second assessment on p.o. day 14, which gave a negative result. The 4th positive case had a positive second assessment on p.o. day 14 and a third negative one on p.o. day 21. In a total of 20 assessments both TRUS and FC were performed. The results of the two procedures were always in accordance. CONCLUSIONS: We have introduced TRUS assessment of vescicourethral anastomosis after laparoscopic radical prostatectomy as a routine procedure in our department. We are planning a comparative study, using FC as the gold standard, for validation purposes.

[Severe hypoglycemia caused by sulfonylureas and biguanides in a patient with obstructive anuria: resolution with ureteral stent]. / Grave ipoglicemia da sulfaniluree e biguanidi in paziente anurica ostruttiva: risoluzione con posizionamento di stent ureterale.

We report about a single kidney patient affected by a critical hypoglycemia due to acute renal failure in obstructive uropathy whilst receiving sulfonylureas and biguanides for diabetes. Clinical picture was successfully treated by endoureteral lithotripsy and placing a double j catheter.

Neoadiuvant Treatment With Intravesical Interleukin-2 for Recurrent Superficial Transitional Bladder Carcinoma Ta-T1/G1-2.

SUMMARY: The aim of this study was to evaluate the direct action of IL-2 on recurrent superficial transitional bladder carcinoma and the effect on recurrence rate. 27 patients were submitted to neoadjuvant treatment by intra-vesical instillation of recombinant IL-2 and to transurethral resection. We did not observe any effect on neoplasms but the recurrence rate was less than the expected one. It is possible that treatment of bladder carcinoma with intra-vesical instillation of IL-2 may promote immuno-prophilaxis.