Overactive bladder (OAB) affects one in six adults in Europe and the United States and impairs the quality of life of millions of individuals worldwide. When conservative management fails, third-line treatments including tibial neuromodulation (TNM) is often pursued. TNM has traditionally been accomplished percutaneously in clinic.
A minimally invasive implantable device activated by a battery-operated external wearable unit has been developed for the treatment of urgency urinary incontinence (UUI), mitigating the burden of frequent clinic visits and more invasive therapies that are currently commercially available.
A prospective, multicenter, single-arm, open-label, pivotal study evaluated the safety and effectiveness of the device in adult females with UUI (i.e., wet OAB) (BlueWind Implantable Tibial Neuromodulation [iTNM] system; IDE number #G200013; NCT03596671). Results with the device were previously published under the name RENOVA iStim, which has been since renamed as the Revi™ System. Approximately 1-month post-implantation of the device, participants delivered therapy at their convenience and completed a 7-day voiding diary before visits 6- and 12-months post-treatment initiation. The primary efficacy and safety endpoints were the proportion of responders to therapy ( ≥ 50% improvement on average number of urgency-related incontinence episodes) and incidence of adverse events from implantation to 12-month post-activation.
A total of 151 participants, mean age 58.8 (SD: 12.5), were implanted; 144 and 140 completed the 6- and 12-month visits, respectively. The participants demonstrated mean baseline of 4.8 UUI/day (SD 2.9) and 10 voids/day (SD 3.3). Six and 12-months post-activation, 76.4% and 78.4% of participants, respectively, were responders to therapy in an intent-to-treat analysis. Of the 139 participants with completed 12-month diaries, 82% were responders, 50% were classified as "dry" (on at least 3 consecutive diary days), and 93.5% of participants reported that their symptoms improved. No implanted participant experienced an SAE related to the procedure or device.
iTNM, delivered and powered by a patient-controlled external wearable communicating with an implant, demonstrated clinically meaningful and statistically significant improvement in UUI symptoms and a high safety profile. This therapy highlights the value of patient-centric therapy for the treatment of UUI.
Neurourology and urodynamics. 2024 Apr 18 [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, 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 & Urogynecology, Omaha, Nebraska, USA., Department of Urology, ASTARC Faculty of Medicine and Health Sciences, 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 Diego, California, USA., Louisiana State University Medical Center, Shreveport, Louisiana, USA., Florida Urology Partners, Tampa, Florida, USA., Chesapeake Urology Research Associates, Baltimore, Maryland, USA., Urogynecology and Reconstructive Surgery, University of California, Irvine, Irvine, California, USA., BlueWind Medical Inc., Park City, Utah, USA.