Aquablation therapy demonstrated strong efficacy and safety vs transurethral resection of the prostate (TURP) for the treatment of men with lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH), according to 5-year results from the pivotal WATER trial published in the Canadian Journal of Urology.1,2
International Prostate Symptom Score (IPSS) data at 5 years showed that among patients receiving Aquablation, IPSS improved by 15.1 points compared with 13.2 points among patients receiving TURP (P = .2764). Of note, across all follow-up visits for patients with larger prostates (>50 mL), the reduction in IPSS was 3.5 points higher with Aquablation vs TURP (P = .0123). Peak urinary flow rate compared to baseline improved by 125% vs 89% in the Aquablation and TURP groups, respectively. The rate of retreatment (needing surgical intervention or BPH medication) for patients receiving Aquablation was about 1% per year. Compared to TURP, this represented a 51% reduction.
“The urological community has been waiting to see if the early, pronounced benefits from Aquablation would remain over time. With the 5-year data from a randomized study now available, the Aquablation results are quite durable and look to have a very low rate of men needing an additional treatment. Given the broader range of prostate size and anatomy Aquablation can treat, this technology has the potential to change the paradigm of how BPH is treated,” Alexis E. Te, MD, an investigator on the WATER study and a professor of Urology at the Weill Medical College at Cornell University, stated in a news release.
The prospective, randomized, double-blind, multicenter WATER trial (NCT02505919) compared the safety and efficacy of Aquablation and TURP as surgical treatments for BPH-related LUTS in men aged 45 to 80 years old who had a prostate size of 30 mL to 80 mL. Patient characteristics at baseline were well balanced between the study arms. Patients were randomized in a 2:1 ratio to Aquablation or TURP. The 5-year analysis included 116 patients randomized to Aquablation and 65 patients randomized to TURP.
It was previously determined that the study met its primary end point with Aquablation leading to a 16.9 mean IPSS decrease from baseline compared with a mean decrease of 15.1 points with TURP (P <.0001 for noninferiority; P = .1346 for superiority).
Regarding safety, the event rate at 3 months was 26% with Aquablation vs 42% with TURP (P = .0149). The rate of procedure-related ejaculatory dysfunction was 7% vs 25%, respectively (P = .0004).
“Based on our 5-year WATER data and real-world experience, we believe Aquablation therapy is poised to become the treatment of choice for BPH as it addresses the compromise between safety and efficacy. This study reinforces the durability of Aquablation therapy, and we are thrilled that men everywhere suffering from BPH now have a surgical treatment option with proven clinical outcomes, independent of the size and shape of the prostate, and a reduced risk of sexual side effects,” Reza Zadno, president and CEO of PROCEPT BioRobotics, a developer of Aquablation treatment, stated in the news release.
1. PROCEPT Announces 5-Year WATER Study Data Comparing Aquablation to TURP.Published online February 14, 2022. Accessed February 28, 2022. https://bit.ly/3prlE2H.
2. Gilling PJ, Barber N, Bidair M, et al. Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH. Can J Urol. 2022;29(1):10960-10968.