Upcoming event

Pivotal study of a leadless tibial nerve stimulator for Urgency Urinary Incontinence (UUI): 2-Year outcomes from a single site

Introduction and objective

A novel leadless, fully-implantable tibial nerve stimulator has unique attributes compared to current OAB treatments including automated compliance, a brief procedure using only local anesthetic and reliance on minimal resources. Patient experience with this device (eCoin®) was evaluated after 96 weeks of therapy at a single site.

Methods

This was a prospective, single-arm trial involving 15 US sites with patients who were intolerant of, or showed an inadequate response to, at least one 2nd or 3rd line therapy prior to enrollment. The coin-sized, leadless device is composed of electrodes lining the rim and bottom center, emitting a dome-shaped electrical field with a wide radius. It is implanted subcutaneously in the medial lower leg above the fascia using just local anesthetic. After a short healing period, it delivers automated 30-minute therapy sessions every 3-4 days. The primary endpoint for this study was assessed at 48 weeks post-activation, with patients given the option to participate in an extension phase including a follow up visit at 96 weeks post-activation. This visit included the collection of a 3-day voiding diary, Overactive Bladder Questionnaire (OABq), Patient Global Impression of Improvement in Incontinence (PGI-I), and an assessment of any adverse events.

Results

All 26 subjects reached 96-weeks post-activation. Mean age is 65.8 (±8.8) years, all patients are female, and at baseline patients had an average of 4.6 (±2.7) UUI episodes per day. At 96 weeks post-activation, 81% of subjects were “responders,” indicating they improved by at least 50% in their UUI. Additionally, 54% of patients achieved ≥75% reduction in UUI, and 23% had complete resolution in UUI (dry). Results from the OABq indicate the symptom bother scale was reduced by an average of 35 points, and the HRQoL scale was improved by an average of 30 points at 96 weeks. 82% indicated they were at least “Better” after treatment, and 50% indicated they were “Very Much Better” on the PGI-I. There were no related adverse events recorded during the extension phase of the study.

Conclusions

These single site results suggest long term UUI management with eCoin is efficacious and safe, with the percentage of “responders” increasing from 77% at 48 weeks to 81% at 96 weeks post-activation. Potentially, the eCoin device will greatly treat more OAB patients by eliminating many of the barriers which reduce progression to current third-line therapies often compromised by poor adherence.

Source of funding

Valencia Technologies