Revi® is a novel implantable tibial neuromodulation (iTNM) system powered by an external, battery-operated wearable that facilitates individually tailored stimulation to provide treatment for urgency urinary incontinence (UUI). The Revi System (manufactured by BlueWind Medical) is the first FDA-cleared implantable neuromodulation device that can be used in traditionally non-refractory patients. Three-year follow-up results from the pivotal FDA-approval trial, the OASIS Study, are presented.
The Revi System was implanted in 151 women. The primary efficacy and safety endpoints were assessed at 6 and 12 months, respectively; thereafter, participants were consented to extend follow-up to 3 years for assessments of long-term treatment durability and safety.
Ninety-three percent (140/151) completed the 12-month study and 85% (119/140) met screening criteria and consented to the 36-month extension study. Ninety participants (76%, (90/119) completed the 36-month assessment and 79% (71/90) were therapy responders (≥ 50% reduction in UUI episodes, demonstrated on a 3-day voiding diary). Sustained therapeutic responses were reported, with durable effectiveness between 6 and 36 months (response rates of 78% and 79%, respectively).Notably, 95% (83/87) reported therapeutic satisfaction and 82% (74/90) reported feeling "much better" or "very much better" based on the Patient Global Impression of Improvement (PGI-I) scale. No device- or procedure- related serious adverse events were reported through 36 months.
In women with UUI, Revi - an iTNM system powered by a patient-controlled, external wearable ankle device - showed meaningful and durable efficacy, high patient satisfaction, and an excellent safety profile through 3 years.
The Journal of urology. 2026 Apr 13 [Epub ahead of print]
Cindy L Amundsen, Suzette E Sutherland, John P F A Heesakkers, Philip Toozs-Hobson, Frank Martens, Rebecca J McCrery, Kevin Benson, Kevin J Cline, Peter R Rodine, Roger R Dmochowski
Department of Obstetrics and Gynecology, Division of Urogynecology and Reconstructive Pelvic Surgery, Duke University, Durham, North Carolina, USA., Pelvic Health Center, Arizona Urology Specialists, Scottsdale, Arizona, USA., Department of Urology, Maastricht UMC, Maastricht, The Netherlands., Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK., Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands., Adult Pediatric Urology and Urogynecology, Ohama, Nebraska, USA., Department of Obstetrics and Gynecology, FPMRS Division, Sanford Health, University of South Dakota School of Medicine, Sioux Falls, South Dakota, USA., Louisiana State University Medical Center, Shreveport, Louisiana, USA., BlueWind Medical Inc., Salt Lake City, Utah, USA.