Two-Year Efficacy and Safety Outcomes of the Pivotal OASIS Study Using the Revi System for Treatment of Urgency Urinary Incontinence
John Heesakkers, Philip Toozs‐Hobson, Suzette E. Sutherland, Alex Digesu, Cindy L. Amundsen, Rebecca McCrery, Stefan De Wachter, Emily Kean, Frank Martens, Kevin Benson, Kimberly L. Ferrante, Kevin Cline, Osvaldo Padron, Laura Giusto, Felicia Lane, Lambertus P. W. Witte, Roger R. Dmochowski
Abstract
PURPOSE: The BlueWind Medical Device, 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 (ie, overactive bladder wet). The Revi System is the first Food and Drug Administration-cleared implantable neuromodulation device which can be used without prior failure with more conservative treatment options. Two-year follow-up results of the OASIS (Overactive Bladder Stimulation System) study are presented. MATERIALS AND METHODS: The Revi System was implanted in 151 female participants. The primary efficacy and safety end points were assessed at 6 and 12 months, after which participants either consented to extend follow-up for long-term assessment of treatment durability and safety or they chose to exit the study. RESULTS: Ninety-seven participants completed the 24-month assessment, and of these, 79% were therapy responders (≥50% reduction in urgency urinary incontinence episodes, demonstrated on a 3-day voiding diary). Importantly, therapeutic response was durable, with comparable effectiveness at 6, 12, and 24 months (response rates of 78%, 82%, and 79%, respectively). Participants who completed both the 6- and 24-month assessment had similar demographics and treatment results at the 6-month visit, indicating that these results at 24 months are representative of the overall study population. In addition, high satisfaction and patient impression of improvement were reported, with 97% (88/91) of the participants satisfied with the therapy and 80% (78/97) feeling "much better" or "very much better." There were no serious adverse events related to the device or the procedure through 24 months. CONCLUSIONS: Two-year results demonstrate durable efficacy, high patient satisfaction, and a very favorable safety profile. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03596671.