Roehrborn, Claus G.

AbstractObjectiveThe objective of this study is to determine if Aquablation therapy can maintain its effectiveness in treating men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) with large‐volume (80–150 cc) prostates at 3 years.Subjects and MethodsOne hundred one men with moderate‐to‐severe BPH symptoms and prostate volumes between 80 and 150 cc were enrolled in a prospective, nonrandomized, multicenter, international clinical trial in late 2017. Baseline, procedural, and follow‐up parameters were recorded at baseline and scheduled postoperative visits. IPSS, Qmax, and treatment failure are reported at 3 years.ResultsThe mean prostate volume was 107 cc (range 80–150). Mean IPSS improved from 23.2 at baseline to 6.5 at 3 years (16.3‐point improvement, p < 0.0001). Mean IPSS quality of life improved from 4.6 at baseline to 1.1 at 3 years (improvement of 3.4 points, p < 0.0001). Maximum urinary flow increased from 8.7 to 18.5 cc/s. At 3 year follow‐up, 6% of treated patients needed BPH medication and an additional 3% required surgical retreatment for LUTS.ConclusionsThree‐year follow‐up demonstrates a sustained symptom reduction response along with low irreversible complications to Aquablation in men with LUTS due to BPH and prostates of 80–150 cc. Current treatment options available for men with prostates of this size have similar efficacy outcomes but are burdened with high rates of irreversible complications. There are now numerous clinical studies with Aquablation used in various prostates sizes, and it should be offered as an option to men with LUTS due to BPH.

Objective To compare the outcomes of Aquablation in 30–80 mL prostates with those in 80–150 mL prostates. Surgical options, especially with short learning curves, are limited when treating large prostates for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Aquablation (AquaBeam System, PROCEPT BioRobotics Inc., Redwood City, CA, USA) could solve this issue with global reproducibility, independent of prostate volume. Patients and Methods Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue (WATER [W‐I]; NCT02505919) is a prospective, double‐blind, multicentre, international clinical trial comparing Aquablation and transurethral resection of the prostate (TURP) for the treatment of LUTS/BPH in prostates between 30 and 80 mL. WATER II (W‐II; NCT03123250) is a prospective, multicentre, single‐arm international clinical trial of Aquablation in prostates between 80 and 150 mL. We compare baseline parameters and 12‐month outcomes in 116 W‐I and 101 W‐II study patients. Students’ t ‐test or Wilcoxon tests were used for continuous variables and Fisher’s test for binary variables. Results The mean (SD) operative time was 33 (17) and 37 (13) min in W‐I and W‐II, respectively. Actual treatment time was 4 and 8 min in W‐I and W‐II, respectively. The mean change in the International Prostate Symptom Score was substantial averaging (at 12 months) 15.1 in W‐I and 17.1 in W‐II ( P = 0.605). By 3 months, Clavien–Dindo grade ≥II events occurred in 19.8% of W‐I patients and 34.7% of W‐II patients ( P = 0.468). Conclusion Aquablation clinically normalises outcomes between patients with 30–80 mL prostates and patients with 80–150 mL prostates treated for LUTS/BPH, with an expected increase in the risk of complications in larger prostates. Long‐term outcomes of procedure durability are needed.

Objective To present 6‐month safety and effectiveness data from a multicentre prospective study of aquablation in men with lower urinary tract symptoms (LUTS) attributable to benign prostatic hyperplasia ( BPH ) with prostate volumes between 80 and 150 mL. Methods Between September and December 2017, 101 men with LUTS attributable to BPH were prospectively enrolled at 16 centres in Canada and the USA. Results The mean prostate volume was 107 mL. The mean length of hospital stay after the aquablation procedure was 1.6 days (range: same day to 6 days). The primary safety endpoint (Clavien–Dindo grade 2 or higher or any grade 1 event resulting in persistent disability) at 3 months occurred in 45.5% of men, which met the study design goal of < 65% ( P < 0.001). At 6 months, 22% of the patients had experienced a Clavien–Dindo grade 2, 14% a grade 3 and 5% a grade 4 adverse event. Bleeding complications requiring intervention and/or transfusion were recorded in eight patients prior to discharge and in six patients after discharge. The mean International Prostate Symptom Score improved from 23.2 ± 6.3 at baseline to 6.7 ± 5.1 at 3 months, meeting the study's primary efficacy endpoint goal ( P < 0.001). The maximum urinary flow rate increased from 8.7 to 18.8 mL/s ( P < 0.001) and post‐void residual urine volume decreased from 131 at baseline to 47 at 6 months ( P < 0.0001). At 6 months, prostate‐specific antigen concentration reduced from 7.1 ± 5.9 ng/mL at baseline to 4.0 ± 3.9 ng/mL, a 44% reduction. Conclusions Aquablation is safe and effective in treating men with larger prostates (80–150 mL), without significant increase in procedure or resection time.

ABSTRACT Introduction Most surgical treatments for male lower urinary tract symptoms and benign prostatic hyperplasia affect erectile and ejaculatory functions negatively, leading to patient dissatisfaction. Aim To determine whether water vapor thermal therapy, when conducted in a randomized controlled trial, would significantly improve lower urinary tract symptoms secondary to benign prostatic hyperplasia and urinary flow rate while preserving erectile and ejaculatory functions. Methods Men at least 50 years old with International Prostate Symptom Scores of at least 13, a peak flow rate of at least 5 to no higher than 15 mL/s, and prostate volume of 30 to 80 cm3 were randomized 2:1 between Rezūm System thermal therapy and control. Thermal water vapor (103°C) was injected into lateral and median lobes as required for treatment of benign prostatic hyperplasia. The control procedure entailed rigid cystoscopy with simulated active treatment sounds. Main Outcome Measures Blinded group (active = 136, control = 61) comparison occurred at 3 months and the active arm was followed to 12 months for International Prostate Symptom Score, peak flow rate, and sexual function using the International Index of Erectile Function and the Male Sexual Health Questionnaire for Ejaculatory Function. The minimal clinically important difference in erectile function perceived by subjects as beneficial was determined for each erectile function severity category. Subjects not sexually active were censored from sexual function analysis. Results No treatment- or device-related de novo erectile dysfunction occurred after thermal therapy. International Index of Erectile Function and Male Sexual Health Questionnaire for Ejaculatory Function scores were not different from the control group at 3 months or from baseline at 1 year. Ejaculatory bother score improved 31% over baseline (P = .0011). Also, 32% of subjects achieved minimal clinically important differences in erectile function scores at 3 months, and 27% at 1 year, including those with moderate to severe erectile dysfunction. International Prostate Symptom Score and peak flow rate were significantly superior to controls at 3 months and throughout 1 year (P &lt; .0001). Conclusion Convective water vapor thermal therapy provides sustainable improvements for 12 months to lower urinary tract symptoms and urinary flow while preserving erectile and ejaculatory functions.

Objectives To assess the safety and efficacy of tadalafil once daily on lower urinary tract symptoms suggestive of clinical benign prostatic hyperplasia ( BPH‐LUTS ) in men without erectile dysfunction ( ED ). To compare these with effects in men with ED . Patients and Methods After a 4‐week washout period and 4‐week placebo run‐in period, 1089 men without ED ( n = 338) and with ED ( n = 751) were randomly assigned to placebo or tadalafil 5 mg once daily for 12 weeks in three global clinical studies with similar designs. In the pooled dataset, post hoc analyses of covariance assessed the impact and severity of BPH‐LUTS using the I nternational P rostate S ymptom S core ( IPSS ) and the BPH I mpact I ndex ( BII ) and IPSS quality‐of‐life ( IPSS ‐ QoL ) subscores. Safety was assessed using treatment‐emergent adverse events. The treatment‐by‐ ED ‐status interaction was used to assess efficacy differences between the with/without ED subgroups. Results Men without ED were similar in BPH‐LUTS severity/previous therapy to men with ED . Tadalafil significantly reduced BPH‐LUTS from baseline when compared with placebo in men without ED ( IPSS −5.4 vs −3.3, P < 0.01; IPSS voiding subscore −3.5 vs −2.0, P < 0.01; IPSS storage subscore −1.9 vs −1.3, P < 0.05). Tadalafil also significantly improved quality of life from baseline when compared with placebo in men without ED ( IPSS ‐ QoL −1.0 vs −0.7, BII −1.4 vs −1.0; both P < 0.05). Between‐ ED ‐subgroup interactions were not significant (all P > 0.68). Tadalafil was safe and well tolerated. Conclusion Tadalafil 5 mg once daily improved BPH‐LUTS in men without ED by a magnitude similar to that observed in men with ED . The adverse event profile in men without ED was consistent with that observed in men with ED .