Three-year efficacy and safety of Revi implantable tibial neuromodulation from the pivotal OASIS Study
Amundsen, Cindy L Sutherland, Suzette E Heesakkers, John P F A Toozs-Hobson, Philip Martens, Frank McCrery, Rebecca J Benson, Kevin Cline, Kevin J Rodine, Peter R Dmochowski, Roger R
Amundsen, Cindy L
Sutherland, Suzette E
Heesakkers, John P F A
Toozs-Hobson, Philip
Martens, Frank
McCrery, Rebecca J
Benson, Kevin
Cline, Kevin J
Rodine, Peter R
Dmochowski, Roger R
Abstract
PURPOSE: 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 nonrefractory patients. Three-year follow-up results from the pivotal FDA-approval trial, the OASIS Study, are presented.
MATERIALS AND METHODS: The Revi System was implanted in 151 women. The primary efficacy and safety end points 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.
RESULTS: 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-related or procedure-related serious adverse events were reported through 36 months.
CONCLUSIONS: 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.
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Date
2026-04-13
Type
Article
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Citation
Amundsen CL, Sutherland SE, Heesakkers JPFA, Toozs-Hobson P, Martens F, McCrery RJ, Benson K, Cline KJ, Rodine PR, Dmochowski RR. Three-Year Efficacy and Safety of Revi Implantable Tibial Neuromodulation from the Pivotal OASIS Study. J Urol. 2026 Apr 13:101097JU0000000000005062. doi: 10.1097/JU.0000000000005062. Epub ahead of print.