Implantable Device Shows Long-Term Benefits for Urinary Incontinence, Reveals Research

The Revi system by BlueWind Medical is a new implantable tibial neuromodulation (iTNM) device that features an external, wearable, battery-operated unit. The device’s stimulation parameters can be customized using a Clinician Programmer to optimize its effectiveness. Suzette E. Sutherland from Scottsdale, AZ, and colleagues summarized the quality-of-life (QoL) outcomes from a previously reported prospective, multi-center, single-arm pivotal trial, which evaluated the efficacy and safety of iTNM in treating urgency urinary incontinence in women.

For this purpose, the researchers performed subfascial implantation of the device over the posterior tibial nerve under local anesthesia in 151 female subjects. After initial healing, the subjects used an external wearable ankle cuff for stimulation treatments at home. Voiding diaries were collected at 1, 3, 6, 9, 12, 18, and 24 months, while quality-of-life questionnaires, including the Overactive Bladder Questionnaire (OAB-q), Patient Global Impression of Improvement (PGI-I), and Benefit Satisfaction and Willingness to Continue (BSW), were gathered at 6, 12, and 24 months.

The primary endpoint, UUI response rate (≥50% decrease in UUI episodes), was achieved, with previously reported results showing UUI response rates of 77.8% (112/144) at 6 months, 82.0% (114/139) at 12 months, and 79.4% (77/97) at 24 months.

Key Findings:

• Consistent quality of life (QoL) benefits were observed throughout the 24 months, with clinically significant (≥ 10 points) and stable improvements in all domains of the OAB-q.
• At 24 months, 87.2% of participants reported a ≥ 10-point improvement in total transformed Health-Related Quality of Life (HRQL) score.
• At 24 months, 96.8% of participants reported a treatment benefit, 96.7% (88/91) expressed satisfaction, and 100% were willing to continue the therapy.
• Even among subjects who did not meet the primary efficacy endpoint at 24 months (N=20; 21%), a significant number still reported notable benefits.
• At 24 months, 83.3% of these subjects acknowledged a treatment benefit, 66.7% expressed satisfaction, and 100% were willing to continue therapy.

In conclusion, implantable tibial neuromodulation using the Revi system shows promise as an effective treatment for urgent urinary incontinence. The two-year results highlight meaningful and lasting improvements in bladder-related quality of life, even among patients who did not fully meet the primary efficacy criteria.

Reference:

Sutherland SE, Heesakkers JPFA, Ferrante KL, Dmochowski RR. PD39-12 QUALIFY-OF-LIFE OUTCOMES OF IMPLANTABLE TIBIAL NEUROMODULATION FOR URGENCY URINARY INCONTINENCE: TWO-YEAR RESULTS FROM THE OASIS PIVOTAL STUDY USING THE REVI SYSTEM. Journal of Urology [Internet]. 2025 May 1 [cited 2025 May 3];213(5S):e1355. Available from: https://doi.org/10.1097/01.JU.0001110196.19418.44.12