3rd Annual Jefferson Urology Symposium: Men’s Health Forum

© The Canadian Journal of Urology TM : International Supplement, August 2020 Das ET AL. multicenter, prospective noninferiority trial comparing the safety and efficacy of Aquablation to TURP in 181 men ranging 45-80 years old with prostate sizes 30-80 grams (TRUS), moderate to severe baseline LUTS (IPSS ≥ 12), and Qmax < 15 mL/sec. 9 End points included efficacy (reduction in IPSS at 6 months) and safety (development of Clavien-Dindo persistent grade 1, or 2 or higher operative complications). Results demonstrated that Aquablation was noninferior to TURP in efficacy (mean difference in the change IPSS score at 6 months was 1.8 points greater for men undergoing Aquablation [noninferiority p < 0.0001]) and superior to TURP in safety (26% of men in the Aquablation group versus 42% of men undergoing TURP experienced a primary safety end point [p = 0.0149]). Of note, there were significantly lower rates of anejaculation in sexually active men treated with Aquablation (10% versus 36% TURP, p = 0.0003). This is likely due to the unique ability to carefully define the target area of prostate ablation, thereby avoiding damage near the verumontanum. Additionally, Aquablation demonstrated faster resection times (4 versus 27minutes [TURP], p < 0.0001) despite similar mean total operative times (33 versus 36 minutes [TURP], p = 0.2752). Subgroup analysis of the WATER trial looking at men with 50-80 g prostates demonstrated significantly superior IPSS score improvement and superior safety profile with significantly lower rates of postoperative anejaculation in men undergoing Aquablation .10 Furthermore, recently published 3-year outcome data of theWATER trial, summarized in Table 1, demonstrated similar improvements in patient symptom scores, quality of life, and uroflow parameters in the Aquablation and TURP groups, but with significantlymarked reduction in postoperative anejaculation after Aquablation (p = 0.0039). 11 Expanding on the results of the WATER trial, Desai et al conducted the WATER II trial to assess safety and efficacy of Aquablation in larger prostates (80-150 mL). 12 The WATER II trial defined the same efficacy and safety primary end points as the original WATER I trial, however lacked a direct comparative control arm (TURP). The initial data included 101 enrolled men and demonstrated adequate adenoma resection with a single pass in 34 patients, and with additional passes in 67 patients (mean 1.8 treatment passes). The primary safety endpoint of Clavien-Dindo grade ≥ 2 event rate at 1monthwas 29.7%with bleeding complications recorded in 10 patients (9.9%), including 6 (5.9%) peri-operative transfusions. Nonetheless, the published 6-month follow up data showed that the 4 TABLE 1. Three-year outcome data from the Aquablation WATER trial Clinical outcomes - Mean (SD) Measure Aquablation TURP p value IPSS reduction 14.4 (6.8) 13.9 (8.6) 0.6848 IPSS reduction 3.5 points larger reduction with Aquablation 0.0125 (Larger prostates ≥ 50 cc) IPSS QoL improvement 3.2 (1.8) 3.2 (1.7) 0.7845 Changes in MSHQ-EjD 2.8 points lower with TURP 0.0008 MSHQ bother score 0.6 points higher in TURP 0.0411 IIEF-15 no statistically significant changes not significant Qmax improvement 11.6 (14) cc/sec 8.2 (8) cc/sec 0.0848 PVR reduction 52 (163) cc 53 (224) cc 0.9801 PSA reduction 0.9 ng/dL 1.1 ng/dL 0.5983 Anejaculation rate 11% 29% 0.0039 Urethral stricture rate 0.9% 6.2% 0.0567 Meatal/submeatal stenosis rate 2.5% 0.0% 0.5539 Retreatment rate 4.3% 1.5% 0.4219 IPSS = International Prostate Symptom Score; QoL= quality of life; MSHQ-EjD =Male Sexual Health Questionnaire-Ejaculatory Dysfunction; IIEF-15 = International Index of Erectile Function-15; Qmax = maximum urinary flow rate; PVR = post-void residual urine; PSA = prostate-specific antigen