PROCEPT BioRobotics Corporation has announced positive five-year results from its 181 patient randomized WATER study comparing Aquablation therapy to TURP, the historical standard of care for treating BPH.
WATER is the only prospective, randomized, double-blind, multicenter FDA pivotal study comparing the safety and efficacy of Aquablation to TURP. The study proved superior safety due to low irreversible complications and also superior symptom relief for prostates in the range of 50 milliliters or greater.
At five years, IPSS scores improved by 15.1 points in the Aquablation group and 13.2 points in TURP (p=.2764). However, for men with larger prostates greater than 50 milliliters, IPSS reduction was 3.5 points greater across all follow-up visits in the Aquablation group compared to the TURP group (p=.0123). Improvement in peak urinary flow rate was 125% and 89% compared to baseline for Aquablation and TURP, respectively. Retreatment rates, defined as needing BPH medication or surgical intervention, was approximately 1% per year for Aquablation, which was a 51% reduction compared to TURP.
“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,” said Dr. Alexis E. Te1, Professor of Urology at the Weill Medical College at Cornell University.
“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,” said Reza Zadno, President and Chief Executive Officer of PROCEPT BioRobotics.
To view the publication, visit: https://www.canjurol.com/html/free-articles/Cdn_JU29_I1_05_FREE_DrGilling.pdf
1Dr. Alexis E. Te was a study site principal investigator for the WATER study and consultant to PROCEPT BioRobotics.
Source: Procept BioRobotics.