Three-Year Efficacy and Safety of Revi Implantable Tibial Neuromodulation from the Pivotal OASIS Study
Year: 2026
Type: article
Abstract: PURPOSE: Revi is a novel implantable tibial neuromodulation system powered by an external, battery-operated wearable that facilitates individually tailored stimulation to provide treatment for urgency urinary incontinence. 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 urgency urinary incontinence 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 scale. No device-related or procedure-related serious adverse events were reported through 36 months. CONCLUSIONS: In women with urgency urinary incontinence, Revi-an implantable tibial neuromodulation 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.
Source: The Journal of Urology
Institutions: Duke University, Duke Medical Center, Maastricht University Medical Centre, Maastricht University, Birmingham Women’s and Children’s NHS Foundation Trust, Radboud University Medical Center, Sanford Health, University of South Dakota, Louisiana State University, Utah State Historical Society, Utah Department of Natural Resources
Language: English
Subfield: Urology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,000
OpenAlex ID: W7154167215