Two-year efficacy and safety outcomes of the pivotal OASIS Study using the Revi® System for treatment of urgency urinary incontinence.

Abstract

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 (i.e., overactive bladder wet). The Revi System is the first FDA-cleared implantable neuromodulation device which can be used without prior failure with more conservative treatment options. Two-year follow-up results of the OASIS Study are presented. The Revi System was implanted in 151 female participants. The primary efficacy and safety endpoints 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. Ninety-seven participants completed the 24-month assessment, and of these, 79% were therapy responders (≥ 50% reduction in urgency urinary incontinence episodes (UUIE), 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 that 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. Two-year results demonstrate durable efficacy, high patient satisfaction, and a very favorable safety profile.