Bilal Chughtai1, Dominique Thomas2. 1. Weill Cornell Medical College, New York, NY, USA. bic9008@med.cornell.edu. 2. Weill Cornell Medical College, New York, NY, USA.
Abstract
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 Qmax 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.
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 Qmax 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.
Authors: Peter Gilling; Neil Barber; Mohamed Bidair; Paul Anderson; Mark Sutton; Tev Aho; Eugene Kramolowsky; Andrew Thomas; Barrett Cowan; Ronald P Kaufman; Andrew Trainer; Andrew Arther; Gopal Badlani; Mark Plante; Mihir Desai; Leo Doumanian; Alexis E Te; Mark DeGuenther; Claus Roehrborn Journal: Adv Ther Date: 2019-04-26 Impact factor: 3.845