Opinion
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Treatment with the Revi System led to durable QOL benefits at 24 months, even among those patients who did not achieve the primary end point.
Treatment of urgency urinary incontinence (UUI) with the Revi System was associated with clinically relevant and durable benefits in quality of life, according to 2-year data from the pivotal OASIS trial, which were presented at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada.1
The Revi System was approved for the treatment of patients with UUI in August 2023 based on safety and efficacy data from the OASIS trial.2 Overall, the UUI response rate in the trial was 77.8% at 6 months, which remained consistent at 82.0% at 12 months and 79.4% at 24 months. There were no serious procedure- or device-related adverse events.
In an interview with Urology Times®, Roger R. Dmochowski, MD, MMHC, FACS, walked through the background and key QOL findings from the trial. Dmochowski is a professor of urology and surgery at Vanderbilt University Medical Center in Nashville, Tennessee. He also serves as the Chief Medical Officer for BlueWind Medical.
Overall, at 24 months, 87.2% of patients reported at least a 10-point change from baseline in total transformed Health-Related Quality of Life score. Further, 96.8% of patients reported treatment benefit, 96.7% of patients reported satisfaction with treatment, and 100% of patients reported a willingness to continue therapy.
There were also QOL benefits observed in patients who did not meet the primary efficacy end point at 24 months (n = 20). Among these patients, 83.3% reported treatment benefit, 66.7% reported satisfaction with treatment, and 100% reported a willingness to continue therapy.
Based on these data, Dmochowski concluded, “The real take-home from this study was durability and sustainability of effect, not only objectively measured, but also subjectively.”
REFERENCE
1. Sutherland SE, Heesakkers JPFA, Ferrante KL, Dmochowski RR. Quality-of-life outcomes of implantable tibial neuromodulation for urgency urinary incontinence: Two-year results from the OASIS pivotal study using the Revi System. J Urol. 2025;213(5S):e1355. doi:10.1097/01.JU.0001110196.19418.44.12
2. BlueWind Medical's Revi System secures U.S. FDA de novo classification grant for the treatment of urgency incontinence. News release. BlueWind Medical. August 17, 2023. Accessed June 23, 2025. https://www.prnewswire.com/news-releases/bluewind-medicals-revi-system-secures-us-fda-de-novo-classification-grant-for-the-treatment-of-urgency-incontinence-301903199.html
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