Impact of Revi® Implantable Tibial Neuromodulation on Quality of Life in Patients with Urgency Urinary Incontinence.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate quality-of-life (QoL) improvements following Revi® implantable tibial neuromodulation (ITNM) in patients with urgency urinary incontinence (UUI).

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.