The objective was to evaluate quality-of-life (QoL) improvements following Revi® implantable tibial neuromodulation (ITNM) in patients with urgency urinary incontinence (UUI).
This prospective, multicenter study evaluated the Revi® System, an ITNM device that allows for at-home therapy using an external, battery-operated unit.
The primary efficacy and safety endpoints were assessed at 6 and 12 months; thereafter, participants either exited the study or consented to extend follow-up. This completers analysis evaluated QoL outcomes using the Overactive Bladder Questionnaire (OAB-q) and the total transformed Health-Related QoL (HRQL) score through 24 months.
Subfascial implantation of the Revi System was performed in 151 participants. Primary efficacy and safety endpoints were met and no device- or procedure-related serious adverse events occurred. Consistent QoL benefits were seen throughout 24 months, with clinically significant (≥ 10-point change) and sustainable improvements in symptom severity in all domains of the OAB-q and HRQL scores. Additionally, 96.8% reported treatment benefit, 96.7% reported satisfaction, and 100% reported a willingness to continue therapy at 24 months. Notably, among participants who did not meet the primary efficacy endpoint at 24 months (n = 20; 20.6%), appreciable therapeutic benefit was still noted; 83.3% reported treatment benefit, 66.7% reported satisfaction, and 100% reported a willingness to continue this therapy.
Revi is an effective and safe intervention for UUI. Two-year results of the Revi System demonstrate clinically meaningful and sustainable improvements to bladder-related and overall health-related QoL, including those whose objective benefit did not meet the primary efficacy endpoint.
International urogynecology journal. 2026 Feb 23 [Epub ahead of print]
Suzette E Sutherland, John P F A Heesakkers, Kimberly L Ferrante, Roger R Dmochowski
Arizona Urology Specialists - United Urology Group, Scottsdale, AZ, USA. ., Department of Urology, Maastricht UMC, Maastricht, The Netherlands., Kaiser Permanente, San Diego, CA, USA., Vanderbilt University Medical Center, Nashville, TN, USA.
PubMed http://www.ncbi.nlm.nih.gov/pubmed/41729249