1. Aquablation Therapy in Large Prostates (80-150 mL) for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: Final WATER II 5-Year Clinical Trial Results.
- Author
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Bhojani, Naeem, Mo Bidair, Kramolowsky, Eugene, Desai, Mihir, Doumanian, Leo, Zorn, Kevin C., Elterman, Dean, Kaufman Jr., Ronald P., Eure, Gregg, Badlani, Gopal, Plante, Mark, Uchio, Edward, Gin, Greg, Paterson, Ryan, So, Alan, Roehrborn, Claus, Motola, Jay, Kaplan, Steven, and Humphreys, Mitch
- Subjects
BENIGN prostatic hyperplasia ,URINARY organs ,POLYWATER ,TRANSURETHRAL prostatectomy ,PROSTATE ,RETENTION of urine ,CASTRATION-resistant prostate cancer - Abstract
Purpose: 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. Materials and Methods: 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. 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. Conclusions: 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). [ABSTRACT FROM AUTHOR]
- Published
- 2023
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