2 Year Results: Revi™ Therapy, Implanted Neuromodulator for Urgency Incontinence

Objectives: The BlueWind Medical Device, ReviTM, is a novel implantable tibial neuromodulation (iTNM) system that uses an external, wearable, battery-operated unit. A Clinician Programmer is used to individually tailor stimulation parameters for optimization of efficacy (Fig. 1).

This abstract reports on two-year follow-up of a prospective, multi-center, single arm pivotal trial evaluating the safety and efficacy of iTNM for treatment of urgency urinary incontinence (UUI) in women.

Methods: Inclusion criteria required at least 9 UUI episodes on a 7-day diary. Subfascial implantation of the device over the posterior tibial nerve occurred under local anesthesia in 151 female subjects. After initial healing, subjects performed stimulation treatments at home for 30-minutes twice daily. Subjects were followed for one-year post-activation, after which they either consented to extended follow-up or exited the study. Subjects continuing to long-term follow-up were asked to treat themselves per physician discretion but not less than two 30-minute treatment sessions per week. Voiding diaries were collected at 1,3,6,9,12,18,and 24 months and Patient Global Impression of Improvement (PGI-I) and Benefit Satisfaction and Willingness to Continue questionnaires were collected at 6,12, and 24 months.

The primary effectiveness endpoint defined therapy responders as subjects who experienced at least a ≥50% reduction in UUI episodes at 6 months. Adverse events were prospectively collected throughout the study.

Results: Ninety-seven subjects completed the 24-month assessment, and of these 79% were therapy responders, with 56% achieving a ≥75% reduction in UUI. Importantly, therapeutic response was durable, with comparable efficacy at 6-, 12-, and 24-months (response rates 78%, 82%, and 79%, respectively) (Fig 2). In addition, 97% (88/91) were satisfied with the therapy and 80% (78/97) reporting feeling much better or very much better on the PGI-I at 24 months.

One delayed surgical site-related adverse event was reported between 12 and 24 months due to an exuded non-absorbable, braided suture, resulting in a superficial infection that was successfully managed without device explantation. There were no serious adverse events related to the device or the procedure through 24 months.

While not all subjects elected to continue in the long-term follow-up portion of the study, the 97 subjects that completed the 24-month assessment demonstrated great similarity with the population completing the initial 6-month assessment (n=144) in demographics (age: 59.6 vs. 59.0), baseline urinary parameters (UUI/day: 4.5 vs. 4.8; voids/day: 10.1 vs. 10.1), and response rates at 6 months (82% vs. 78%).

Conclusions: iTNM has emerged as a promising intervention for UUI. Two-year results of the ReviTM system demonstrate sustained efficacy with high satisfaction and a favorable safety profile. Subjects that completed both the 6-month assessment (n=144) and the 24-month assessment (n=97) had similar demographics and results at the 6-month visit, indicating that results at 24-months are representative of the overall study population.