Voiding symptoms among variables studied
IPSS subscore analyses showed a similar 10-point improvement in voiding symptoms in both treatment groups. Storage symptoms, however, improved more rapidly and more profoundly after Aquablation, and at 6 months, the difference between groups was statistically significant.
“A similar pattern emerged for quality of life score, but the treatment difference at 6 months did not achieve statistical significance,” Dr. Roehrborn said.
From baseline to 6 months, Qmax improved by a mean of 18.1 cc/sec in the TURP group and by 21.5 cc/sec among men who had Aquablation, and the difference between groups was statistically significant. There was no significant treatment difference in reduction of postvoid residual urine, which was reduced by about 50% in both groups.
The study design included a prespecified analysis of the primary safety and efficacy endpoints in the subset of men with a prostate volume >50 grams. Differences favoring Aquablation over TURP were even larger among these men with larger glands than in the overall population and statistically significant. Rates of persistent CD1 or CD2 events in the Aquablation and TURP groups were 19% and 43%, respectively, and mean change in IPSS in the two groups was –17.9 and –13.1, respectively.
Men in the WATER study are being followed to 3 years.
Dr. Roehrborn was a consultant to PROCEPT BioRobotics only prior to initiation of the study. His co-author, Peter Gilling, MD, is a consultant/adviser and investigator for PROCEPT BioRobotics. PROCEPT BioRobotics sponsored the WATER study.
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