Abstract

OBJECTIVE: To evaluate the effectiveness and safety of a novel wearable neuromodulation system incorporating embedded electromyographic (EMG) evaluation, representing the first closed-loop wearable therapy for bladder control.METHODS: This 12-week, multicenter, open-label, single-arm study of subjects with Overactive Bladder assessed response of bladder diary parameters and Quality of Life (QOL) metrics. Subjects used the transcutaneous tibial neuromodulation system, either once or three times weekly, with evaluations at weeks 1, 4, 8, and 12. Enrolled subjects (N=96) were assessed for changes in urinary frequency, urgency, and urgency urinary incontinence episodes, and QOL changes using various questionnaires.RESULTS: In the intent-to-treat population (N=96, mean age 60.8 ± 13.0 years, 88.5% female), significant reductions in 3-day diary parameters were observed for daily voids, incontinence and urgency episodes at 12 weeks. Quality of life improvements exceeded the minimal clinically important difference for all QOL questionnaires. Long-term results remained robust at 12 months. Device-related adverse events were mild and there were no device-related serious adverse events. Mean therapy compliance at 12 weeks was 88.5%. High satisfaction rates were reported for the device overall.CONCLUSION: The Avation device demonstrates promising efficacy in treating adults with OAB and UUI. At 12 weeks, both diary parameters and QOL indicators showed significant improvement and remained robust at 12 months. The device had a favorable safety profile with high compliance and patient satisfaction. This novel, closed-loop wearable tibial neuromodulation system represents a significant advancement in bladder control therapy, offering a non-invasive, patient-centered alternative with improved accessibility and ease of use.

View details for DOI 10.1016/j.urology.2023.10.007

View details for PubMedID 37944596