Key result
Revi implantable tibial neuromodulation shows durable efficacy, safety, and high satisfaction through 3 years for UUI.
Why the study?
Does the Revi implantable tibial neuromodulation system provide durable efficacy and safety in women with UUI?
Does the Revi implantable tibial neuromodulation system provide durable efficacy and safety in women with UUI?
The Revi implantable tibial neuromodulation system demonstrates durable efficacy, high satisfaction, and safety over 3 years in women with urge urinary incontinence.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“With the most comprehensive and longest-term data in Implantable Tibial Neuromodulation, BlueWind has set a new benchmark for durable, patient-centered therapy for UUI. Revi delivers consistent, long-lasting outcomes, proving that effective, minimally invasive treatment can be both simple and transformative. These results reinforce Revi's position as the gold standard for clinical evidence, patient satisfaction, and sustained quality-of-life improvement in urgency urinary incontinence.”
“Revi provides a highly effective, sustainable and well-tolerated treatment option for patients with UUI who are living with disruptions to their quality of life.”
“OAB is a chronic and debilitating condition that significantly impairs quality of life with significant financial costs for many people. One in six adults in Europe and the U.S. have OAB. The data published in NAU underscore the effectiveness of Revi as a valuable therapy for individuals living with UUI who oftentimes go untreated.”
May warrant broader adoption for refractory UUI; extends longest-term evidence for implantable tibial neuromodulation.
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.
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Amundsen et al. (2026) studied this question. Revi implantable tibial neuromodulation demonstrated durable efficacy, high patient satisfaction, and an excellent safety profile through 3 years in women with UUI.
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