OBJECTIVE:To provides an overview of the functional and safety outcomes associated with the Optilume BPH catheter system. METHODS:This prospective, single-arm, multi-center, open-label study was conducted at five Canadian centers to evaluate the safety of the endoscopic Optilume BPH (DCB) procedure for LUTS due to benign prostate enlargement from July 2022 to August 2025. The study assessed functional outcomes at baseline, 3, 6, and 12 months. RESULTS:Thirty patients were included in this study, with a mean age of 63.1 ± 7.0 years. The mean prostate volume was 48.5 ± 16.6 mL. IPSS scores decreased from 23.5 ± 5.1 at baseline to 10.8 ± 7.5 at 12 months, while QoL scores improved from 4.7 ± 1.3 to 2 ± 1.6 over the same period. Qmax increased from 8.7 ± 3.7 mL/s to 15.9 ± 5.7 mL/s at 3 months, remaining stable at 14.7 ± 6.9 mL/s at 12 months. No significant differences were observed in sexual function scores. CONCLUSION:The Optilume BPH drug-coated balloon procedure demonstrated significant symptomatic and functional improvements over 12 months.
INTRODUCTION:Rezūm has become an increasingly popular surgical approach for treating bladder outlet obstruction. Despite the practice of routinely placing a Foley catheter, successful TWOC (Trial Without Catheter) remains variable. This study seeks to identify the TWOC failure incidence and risk factors to inform clinical decisions and enhance patient counseling. METHODS:We conducted a retrospective review of non-catheter dependent patients who underwent Rezūm therapy between April 2019 and June 2023 in two high-volume Canadian centers. All patients received a urinary catheter post-treatment. International Prostate Symptom Score (IPSS), QoL, Qmax, and PVR were evaluated. Risk factors for TWOC failure were determined through logistic regression. RESULTS:Out of 406 patients, 99 patients (24.4%) failed TWOC on the first attempt. Median time to TWOC was 7 days (range 3-30 days). Successful and failure groups had no significant difference in terms of average catheterization time, baseline prostate volume, PVR, or total number of injections per prostate volume ratio. A higher rate of UTIs was observed in the TWOC failure group (10.6% vs. 2.6%, p = 0.003). During the 12-month follow-up period, 12 patients developed episodes of urinary retention following Rezūm therapy. Baseline PVR was not a risk factor for failed TWOC in our cohort (p = 0.95). Higher IPSS was a predictor for TWOC failure (OR 1.04 95% CI: 1.01-1.08). CONCLUSIONS:About one in four patients failed the first TWOC after Rezūm therapy. High baseline IPSS was identified as the only risk factor for TWOC failure in our cohort. Despite this, overall urinary symptoms improved in all patients.
OBJECTIVES:Rezūm water vapor thermal therapy is a minimally invasive surgical option with demonstrated efficacy and safety. However, real-world evidence on 2-year outcomes in the population aged above 80 years remains limited. METHODS:A prospective registry was created as part of the International Rezūm Registry database at two high-volume centers. Data were reviewed from patients monitored between April 2019 and August 2024. Men aged ≥ 80 years who underwent Rezūm therapy were included. Baseline and follow-up assessments at 3, 6, 12, and 24 months included International Prostate Symptom Score (IPSS), IPSS Quality of Life (QoL) subscore, peak urinary flow rate (Qmax), and post-void residual volume (PVR). Safety outcomes and adverse events were also recorded. RESULTS:Fifty-eight patients (mean age 84.4 ± 4.4 years) were included, with a mean prostate volume of 80.1 ± 42.1 cc. The mean IPSS decreased from 19.8 ± 7.4 at baseline to 12.4 ± 7.9 at 24 months. The IPSS quality of life (QoL) score declined from 4.2 ± 1.8 at baseline to 2.6 ± 1.5 at the corresponding follow-up interval. Qmax improved from 8.5 ± 5.8 mL/s at baseline to 15.0 ± 4.0 mL/s at 24 months, respectively. PVR was reduced from 115.5 ± 93.7 mL at baseline to 42.8 ± 29.2 mL over the same period. However, neither Qmax nor PVR demonstrated a statistically significant change at any time point. Adverse events were infrequent, with urinary tract infections (8.6%), epididymitis (5.2%), and acute urinary retention (3.4%). Only one patient required hospitalization. CONCLUSION:Rezūm water vapor thermal therapy is a safe and effective treatment for BPH in patients over 80 years of age. It results in durable improvements in urinary symptoms and function with a low rate of complications.
OBJECTIVE:The aim of this study is to evaluate the outcomes of the Rezūm procedure in men aged 50 years or younger, focusing on changes in urinary symptoms and quality of life. METHODS:A prospective registry was created as part of the International Rezūm Registry database at two high-volume centers. The study reviewed data from patients monitored between April 2019 and August 2024. All patients aged 50 years or younger had their baseline medical and BPH history recorded, which included uroflowmetry measurements (Qmax and PVR) and validated questionnaires such as the International Prostate Symptom Score (IPSS), IPSS Quality of Life (QoL), Benign Prostatic Hyperplasia Impact Index (BPHII) and International Index of Erectile Function-15 (IIEF-15). Data were collected at baseline and at 3, 6, and 12 months following the procedure. RESULTS:Fourteen patients were included, with a mean age of 49.6 years (SD 1.05). The mean baseline prostate volume was 54.3 cc (SD: 22.0). At baseline, the mean IPSS was 24.3 ± 5.9, which significantly improved to 10.5 ± 5.8 at 6 months and 11.6 ± 5.4 at 12 months. The IPSS QoL score improved from 4.8 ± 0.9 at baseline to 2.4 ± 1.7 at 12 months. Qmax increased from 7.9 ± 4.5 mL/s to 17.8 ± 6.1 mL/s at 12 months. PVR decreased from 197.6 ± 270.2 mL to 51 ± 77 mL at 12 months. IIEF scores showed no significant differences. CONCLUSION:The Rezūm procedure demonstrates significant efficacy in improving urinary symptoms and quality of life in men under 50.
Objective:The purpose of this study is investigate the clinical outcomes of men with benign prostatic hyperplasia (BPH) and bladder stones treated concomitantly with Aquablation and bladder stone removal in an international, multi-institutional cohort. Patients and Methods:We performed a retrospective analysis of men who underwent Aquablation between 2018 and 2024. Patients were divided into two cohorts: men with bladder stones and those without. Outcomes assessed included baseline demographics and variables (medication use, prostate volume, prior BPH surgery), operative characteristics (OR time, transfusion requirement, complications), and functional outcomes were measured by the International Prostate Symptom Score (IPSS), peak urinary flow rate (Q max) and PVR at regular intervals over 24 months. Results:A total of 1885 men were analysed, including 60 men with bladder stones and 1825 without. Patients with bladder stones had higher rates of prior BPH surgery (15% vs. 5.5%, p = 0.015) and pre-operative urinary retention (28.3% vs. 14.8%, p = 0.004) as well as larger prostate volumes (98.6 ml vs. 77 ml, p < 0.0001). Total operative time was longer in the bladder stone group (76.5 mins vs. 55.0 mins, p < 0.001), but there were no significant differences in Aquablation time or bleeding complications including transfusions. There was also no difference in improvements in IPSS, Q max and PVR post-operatively. Conclusion:This study demonstrates that Aquablation is safe and effective in the management of BPH regardless of concomitant bladder stone treatment.
Rezūm water vapor thermal therapy (WVTT) is an effective minimally invasive treatment for benign prostatic hyperplasia (BPH), offering durable symptom relief while preserving sexual function. However, real-world data on predictors of surgical retreatment remain limited. This study evaluates the incidence of surgical re-intervention following Rezūm therapy in a large multi-center cohort and identifies clinical and procedural factors associated with retreatment. A retrospective analysis was conducted using a prospectively maintained registry from two high-volume international centers in Canada and Italy. Men undergoing Rezūm therapy between April 2019 and August 2025 were included. Baseline demographics, comorbidities, functional outcomes, and intraoperative characteristics were compared between patients with and without surgical retreatment. Univariable and multivariable Cox proportional hazards models were used to evaluate predictors of time to re-intervention. Kaplan–Meier estimates were generated for cumulative incidence of retreatment. Among 837 treated men, 43 (5.1