We report 5-year safety and efficacy outcomes of the Aquablation procedure for the treatment of men with symptomatic benign prostatic hyperplasia and large-volume prostate glands.
A total of 101 men with moderate to severe benign prostatic hyperplasia symptoms and prostate volumes between 80 and 150 mL underwent a robotic-assisted Aquablation procedure in a prospective multicenter international trial (NCT03123250). Herein we report the final 5-year results.
The study successfully met its safety and efficacy performance goal, which was based upon transurethral resection of the prostate outcomes typically done in smaller prostates, at 3 months. Mean prostate volume was 107 mL (range 80-150) at baseline. Patient symptoms showed a significant improvement where the mean (SD) International Prostate Symptom Score of 22.6 (6.4) at baseline to 6.8 (4.6) at 5 years, resulting in a change score of 15.9 (7.7, P < .001). Uroflowmetry measurements also demonstrated improvement where the mean maximum urinary flow rate increased from 8.6 (SD 3.4) to 17.1 (9.8) mL/s at 5 years, resulting in a change score of 9.2 (11.1) mL/s at 5 years (P < .001). A regression analysis evaluating change in PSA as a function of baseline PSA across all time points out to 5 years resulted in a 50% reduction. A prespecified subgroup analysis using a baseline prostate volume cutoff of 100 mL showed no difference in efficacy outcomes through 5 years. Freedom from a secondary benign prostatic hyperplasia procedure at 5 years was 96.3% based on Kaplan-Meier.
At 5-years of prospective follow-up, the Aquablation procedure was shown to be safe with durable efficacy and low rates of retreatment in men with large prostates (80-150 mL).
The Journal of urology. 2023 Apr 28 [Epub ahead of print]
Naeem Bhojani, Mo Bidair, Eugene Kramolowsky, Mihir Desai, Leo Doumanian, Kevin C Zorn, Dean Elterman, Ronald P Kaufman, Gregg Eure, Gopal Badlani, Mark Plante, Edward Uchio, Greg Gin, Ryan Paterson, Alan So, Claus Roehrborn, Jay Motola, Steven Kaplan, Mitch Humphreys
University of Montreal Hospital Center, Université de Montréal, Montreal, Quebec, Canada., San Diego Clinical Trials, San Diego, California., Virginia Urology, Richmond, Virginia., Institute of Urology, University of Southern California, Los Angeles, California., University of Toronto University Health Network, Toronto, Ontario, Canada., Albany Medical College, Albany, New York., Urology of Virginia, Virginia Beach, Virginia., Wake Forest School of Medicine, Winston-Salem, North Carolina., University of Vermont Medical Center, Burlington, Vermont., VA Long Beach Healthcare System, Long Beach, California., University of British Columbia, Vancouver, Canada., Department of Urology, UT Southwestern Medical Center, Dallas, Texas., Icahn School of Medicine at Mount Sinai, New York, New York., Mayo Clinic Arizona, Scottsdale, Arizona.