The BlueWind Medical Device, Revi®, is a novel implantable tibial neuromodulation (iTNM) system that uses an external, wearable, battery-operated unit. A Clinician Programmer is used to tailor stimulation parameters for optimization of efficacy.

This abstract details quality-of-life (QoL) outcomes for a previously reported prospective, multi-center, single arm pivotal trial evaluating efficacy and safety of iTNM for treatment of urgency urinary incontinence (UUI) in women.

Subfascial implantation of the device over the posterior tibial nerve was performed under local anesthesia in 151 female subjects. After initial healing, subjects performed stimulation treatments at home with an external wearable ankle cuff. Voiding diaries were collected at 1,3,6,9,12,18, and 24 months (m) and QoL questionnaires, including the Overactive Bladder Questionnaire (OAB-q), Patient Global Impression of Improvement (PGI-I), and Benefit Satisfaction and Willingness to Continue (BSW), were collected at 6,12, and 24m. The primary endpoint, UUI response rate (≥50% decrease in UUI episodes), was achieved and has been previously reported; UUI response rate was 77.8% (112/144), 82.0% (114/139), and 79.4% (77/97) at 6, 12, and 24m, respectively.

Consistent QoL benefits were seen throughout 24m (see Figure 1), with clinically significant (≥10 point change) and stable improvements in all domains of the OAB-q.  Symptom severity (transformed score), which shows improvement when score decreases, was reduced from 70.3 (n=149) to 32.4 (n=144), 30.6 (n=139), and 31.5 (n=96) at 6m, 12m, and 24m, respectively.  HRQL (transformed score), which increases with improvement up to a maximum of 100, was improved from 46.6 (n=149) to 81.1 (n=144), 81.8 (n=139), and 83.3 (n=96) at 6m, 12m, and 24m, respectively.  Overall, clinically meaningful QoL improvements were reported in 83.1% (n=142), 85.4% (n=137), and 87.2% (n=94) of participants at 6, 12, and 24m, respectively (≥10-point change in total transformed HRQL score). 

Importantly, at 24m, 96.8% (91/94) reported treatment benefit, 96.7% (88/91) reported satisfaction, and 100% (94/94) reported a willingness to continue therapy. Subjects who didn’t meet the efficacy endpoint at 24m (N=20; 21%) often still reported appreciable benefit; at 24 months, 83.3% (15/18) acknowledged treatment benefit, 66.7% (12/18) reported satisfaction, and 100% (18/18) reported a willingness to continue therapy.

The OASIS 24m trial findings support both improvement in UUI episodes and improvements across multiple QoL and satisfaction outcome measures. A previous report demonstrated positive efficacy on UUI episodes with 79% of participants noting a ≥50% improvement in UUI at the 24m timepoint, and 56% experiencing ≥75% improvement (1). The current study expanded on these findings with clinically meaningful benefits seen across multiple measures of QoL that were sustained throughout the treatment duration.

Burden on QoL was alleviated with significant improvements in OAB-q symptom severity, independent HRQL domains (i.e., coping, concern, sleep, and social), total HRQL, PGI-I, and positive BSW following treatment with the Revi System, in parallel to UUI improvements. The minimally important difference (MID) recommended for the OAB-q and all subscales is a 10-point change post-treatment. iTNM treatment improved all domains by at least 20 points at the 24m timepoint with a mean change of 35 points in the overall HRQL score. Notably, improvements in all QoL measures were reported at the first timepoint (6m) and sustained throughout the current study duration of 24m.

iTNM has emerged as an effective intervention for UUI. Two-year results of the Revi system demonstrate clinically-relevant and sustained positive impacts to bladder-related QoL, including in those who didn’t meet the primary efficacy endpoint.

Heesakkers JPFA, Toozs-Hobson P, Sutherland SE, et al. Two-Year Efficacy and Safety Outcomes of the PivotalOASIS Study Using the Revi System for Treatment of Urgency Urinary Incontinence. Journal of Urology. 2025 Mar1;213(3):323–32. https://doi.org/10.1097/JU.0000000000004328