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 study are presented.
Materials and methods: 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.
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.
Keywords: clinical trial; implantable neurostimulators; overactive; quality of life; urge; urinary bladder; urinary incontinence.