Pooled Aquablation Results for American Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in Large Prostates (60-150 cc).

Overview

INTRODUCTION: To present short-term safety and efficacy data of men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) treated with Aquablation. METHODS: Men with LUTs secondary to BPH (60-150 cc) underwent Aquablation treatment from February 2016 to December 2017 across 17 investigational sites in the USA from two contemporary investigational device exemption (IDE) studies called WATER (NCT02505919) and WATER II (NCT03123250). RESULTS: One hundred seven males with mean age of 67.3 ± 6.5 years were treated with Aquablation; mean prostate volume was 99.4 ± 24.1 cc. The pooled results show that large prostates have an average procedure time of less than 36 min and discharge on average 1.6 ± 1 days. The IPSS decreased by 16.7 ± 8.1 points at 3 months and Q_max increased by 11.2 ± 12.4 ml/s. The Clavien-Dindo (CD) grade 2 or higher event rate at 3 months was 29%. A non-hierarchical breakdown for CD events yielded 18% grade 2 and 19% grade 3 or higher. CONCLUSION: Men with LUTS secondary to BPH (60-150 cc) in a pooled analysis were treated safely and effectively with Aquablation up to 3 months postoperatively. TRIAL REGISTRATION: ClinicalTrials.gov identifiers, NCT02505919 and NCT03123250. FUNDING: PROCEPT BioRobotics.