INTRODUCTION: To report 2-year safety and effectiveness of the Aquablation procedure for the treatment of men with symptomatic benign prostatic hyperplasia (BPH) and large-volume 80-150 cc prostates. MATERIALS AND METHODS: Between September-December 2017, 101 men with moderate-to-severe BPH symptoms and prostate volumes of 80-150 cc underwent an ultrasound-guided robotically executed Aquablation procedure in a prospective multicenter international clinical trial (WATER II). Baseline, procedural and follow up parameters were recorded at baseline and scheduled postoperative visits. Herein we report 2-year safety and efficacy for this cohort. RESULTS: Mean prostate volume was 107 cc (range 80-150 cc). Mean IPSS improved from 23.2 at baseline to 5.8 at 2 years (17-point improvement, p < .0001). Mean IPSS quality of life improved from 4.6 at baseline to 1.1 at 2 years (p < .0001). Maximum urinary flow increased from 8.7 to 18.2 cc/sec. Two subjects underwent a repeat procedure for BPH symptoms over the 2-year follow up period. By 2 years or study exit, all but 2 of 74 subjects stopped taking alpha blockers. Similarly, all but 4 of 32 subjects stopped taking 5α-reductase inhibitors. CONCLUSIONS: Two-year prospective multicenter follow up demonstrated that the Aquablation procedure is safe and effective in the treatment of men with LUTS due to BPH and prostates 80-150 cc with durable treatment efficacy, acceptable safety profile and a low retreatment rate. ClinicalTrials.gov number, NCT03123250.
INTRODUCTION: To report 2-year safety and effectiveness of the Aquablation procedure for the treatment of men with symptomatic benign prostatic hyperplasia (BPH) and large-volume 80-150 cc prostates. MATERIALS AND METHODS: Between September-December 2017, 101 men with moderate-to-severe BPH symptoms and prostate volumes of 80-150 cc underwent an ultrasound-guided robotically executed Aquablation procedure in a prospective multicenter international clinical trial (WATER II). Baseline, procedural and follow up parameters were recorded at baseline and scheduled postoperative visits. Herein we report 2-year safety and efficacy for this cohort. RESULTS: Mean prostate volume was 107 cc (range 80-150 cc). Mean IPSS improved from 23.2 at baseline to 5.8 at 2 years (17-point improvement, p < .0001). Mean IPSS quality of life improved from 4.6 at baseline to 1.1 at 2 years (p < .0001). Maximum urinary flow increased from 8.7 to 18.2 cc/sec. Two subjects underwent a repeat procedure for BPH symptoms over the 2-year follow up period. By 2 years or study exit, all but 2 of 74 subjects stopped taking alpha blockers. Similarly, all but 4 of 32 subjects stopped taking 5α-reductase inhibitors. CONCLUSIONS: Two-year prospective multicenter follow up demonstrated that the Aquablation procedure is safe and effective in the treatment of men with LUTS due to BPH and prostates 80-150 cc with durable treatment efficacy, acceptable safety profile and a low retreatment rate. ClinicalTrials.gov number, NCT03123250.
Authors: Kevin C Zorn; Mohamed Bidair; Andrew Trainer; Andrew Arther; Eugene Kramolowsky; Mihir Desai; Leo Doumanian; Dean Elterman; Ronald P Kaufman; James Lingeman; Amy Krambeck; Gregg Eure; Gopal Badlani; Mark Plante; Edward Uchio; Greg Gin; S Larry Goldenberg; Ryan Paterson; Alan So; Mitchell Humphreys; Claus Roehrborn; Steven Kaplan; Jay Motola; Naeem Bhojani Journal: BJUI Compass Date: 2021-10-28
Authors: Chi-Hang Yee; Sui-Fan Tang; Steffi Kar-Kei Yuen; Chi-Kwok Chan; Jeremy Y C Teoh; Peter K F Chiu; Chi-Fai Ng Journal: Int Urol Nephrol Date: 2022-05-27 Impact factor: 2.266
Authors: Iman Sadri; Adel Arezki; Félix Couture; David-Dan Nguyen; Russell Schwartz; Ahmed S Zakaria; Dean Elterman; Enrique Rijo; Vincent Misrai; Thorsten Bach; Claus G Roehrborn; Kevin C Zorn Journal: World J Urol Date: 2020-08-01 Impact factor: 4.226
Authors: Mehmet Yilmaz; Mustafa Karaaslan; Halil Cagri Aybal; Maximilian Ferry von Bargen; Senol Tonyali; Tuncay Toprak; Christian Gratzke; Arkadiusz Miernik Journal: Ann Med Surg (Lond) Date: 2022-07-31
Authors: Dean Elterman; Peter Gilling; Claus Roehrborn; Neil Barber; Vincent Misrai; Kevin C Zorn; Naeem Bhojani; Alexis Te; Mitch Humphreys; Steven Kaplan; Mihir Desai; Thorsten Bach Journal: BMJ Surg Interv Health Technol Date: 2021-06-23
Authors: David-Dan Nguyen; Neil Barber; Mo Bidair; Peter Gilling; Paul Anderson; Kevin C Zorn; Gopal Badlani; Mitch Humphreys; Steven Kaplan; Ronald Kaufman; Alan So; Ryan Paterson; Larry Goldenberg; Dean Elterman; Mihir Desai; Jim Lingeman; Claus Roehrborn; Naeem Bhojani Journal: Eur Urol Open Sci Date: 2021-01-31