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.
The Journal of urology. 2024 Nov 25 [Epub ahead of print]
John P F A Heesakkers, Philip Toozs-Hobson, Suzette E Sutherland, Alex Digesu, Cindy L Amundsen, Rebecca J McCrery, Stefan De Wachter, Emily R Kean, Frank Martens, Kevin Benson, Kimberly L Ferrante, Kevin J Cline, Osvaldo F Padron, Laura Giusto, Felicia L Lane, Lambertus P W Witte, Roger R Dmochowski
Department of Urology, Maastricht UMC, Maastricht, The Netherlands., Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK., Department of Urology, UW Medicine Pelvic Health Center, University of Washington, Seattle, Washington, USA., St Mary's Hospital, Imperial College NHS Trust, London, UK., Department of Obstetrics and Gynecology, Division of Urogynecology and Reconstructive Pelvic Surgery, Duke University, Durham, North Carolina, USA., Adult Pediatric Urology and Urogynecology, Ohama, Nebraska, USA., Department of Urology, ASTARC Faculty of Medicine and Health Science, University of Antwerp, Edegem, Belgium., Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands., Department of Obstetrics and Gynecology, FPMRS Division, Sanford Health, University of South Dakota School of Medicine, Sioux Falls, South Dakota, USA., Kaiser Permanente, San Deigo, California, USA., Louisiana State University Medical Center, Shreveport, Louisiana, USA., Florida Urology Partners, Tampa, Florida, USA., Chesapeake Urology Research Associates, Baltimore, Maryland, USA., University of California, Irvine, California, USA., Department of urology, Isala Clinics, Zwolle, The Netherlands., BlueWind Medical Inc., Park City, Utah, USA.