An experimental treatment called “Aquablation,” which uses high-pressure waterjets to ablate prostate tissue, is associated with better sexual function outcomes compared with transurethral resection of the prostate (TURP) in men with moderate-to-severe lower urinary tract systems in men with benign prostatic hyperplasia (BPH), researchers reported at the Sexual Medicine Society of North America annual meeting in San Antonio, Texas.
The novel procedure provides TURP-like results, but with a lower risk of ejaculatory dysfunction and significantly improved overall sexual satisfaction compared with TURP. Aquablation showed superior efficacy compared with TURP in men with large prostates (50 to 80 mL).
In a randomized, blinded phase 3 trial, Mohamed Bidair, MD, from San Diego Clinical Trials and a clinical professor at the University of California, San Diego, and colleagues compared 117 men treated with robotically-assisted waterjet ablation and 67 who underwent TRUP with standard electrosurgery. At baseline, the Aquablation and TURP groups were similar with respect to mean scores on the International Prostate System Score (IPSS) question (22.9 and 22.2, respectively), mean prostate volume (54 and 52 mL, respectively), and demographic factors. Operative times were equivalent for the Aquablation and TURP groups (32.8 and 35.5 minutes, respectively), but mean resection time was significantly lower in the Aquablation group (4 vs 28 minutes).
The primary safety endpoint (Clavien-Dindo grade 1 persistent or grade 2 or higher event in the first 3 months) occurred in 29 Aquablation recipients (25%) versus 26 TURP patients (40%). The difference in the primary endpoint safety rate was driven primarily by retrograde ejaculation. Among the men who were sexually active at both baseline and study visits, persistent retrograde ejaculation in the first 6 months occurred in 8 Aquablation patients (11.3%) and 16 TURP patients (36.4%). According to the investigators, the upper confidence limit was less than zero, demonstrating superiority of Aquablation versus TURP. Among men who were sexually active at both baseline and study visits, the quality and quantity of ejaculate, as measured by the Male Sexual Health Questionnaire-EjD, increased slightly but not significantly from baseline levels in the Aquablation patients, but decreased significantly by about 2 points in the TURP group. The International Index of Erectile Function (IIEF-5) showed no change in erection quality from baseline in either group. At 6 months, the Aquablation and TURP groups had similar decreases in mean scores on the International Prostate System Score (IPSS) questionnaire (-16.9 vs -15.1 points). In a subgroup of patients with a prostate volume of 50 to 80 mL, the Aquablation group had a significantly greater decline in mean IPSS score than the TURP group (-17.4 vs -13.3 points).
Bidair M, Tallman C, on behalf of WATER Investigators. The WATER Study sexual function results-A phase III blinded randomized parallel group trial of Aquablation vs. transurethral resection of the prostate with blinded outcome assessment for moderate-to-severe LUTS in men with benign prostatic hyperplasia. Presented at the Sexual Medicine Society of North America 18th Annual Fall Scientific Meeting in San Antonia, Texas, October 26-29, 2017.