AUA 2019: Feasibility Data of a Fully-Implanted Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence

Chicago, IL ( Dr. MacDiarmid presented a feasibility trial of fully implanted neuromodulation device for patients with urge urinary incontinence (UUI). The study was conducted in the US and New Zealand. Patients who failed medication, 18 years of age and older with overactive bladder (OAB) symptoms and predominant UUI were included into the study. They were asked to complete a 3-day voiding diary to document daily number of UUI episodes. Potential medication washout was confirmed at 2 weeks. Eligible subjects received the eCoin® implant in office under local anesthesia. Study device slightly larger than a US nickel was placed in fascia above the ankle. It was recommended to keep the wound dry for at least 72 hours post-procedure, and preferably for 2 weeks. 

The eCoin® was activated 4 weeks post-implantation providing lack of complications. Implant was stimulated per subject’s comfort level at the following electrical paradigm: 30 minutes stim every 2 days for 12 weeks and then every 15 days. Participants were evaluated for the duration of 12 months in terms of symptom improvement and adverse events.

Forty six patients with a mean age of 63.4 ± 11.5 years and baseline median UUI of 4.2 ± 2.9 leaks per day were enrolled into the trial. Data analysis noted a statistically significant reduction in a median number of daily UUI episodes over 12 months (1.7 episodes/day; p=0.001). There was a significant change in a percentage of patients who improved in number of UUI leaks relative to the baseline (Figure 1).

Figure 1

Incontinence related quality of life score (I-QOL) has improved for a mean number of 84% since baseline (Figure 2). 

Figure 2

There were few adverse events related to the surgical site generally within one month post-implantation including severe cellulitis secondary to provided ankle wrap, which was resolved with IV antibiotics (1 subject), 1 migration of the eCoin® 1 cm posterior and minor wound healing issues.

Research study demonstrated that the eCoin® is a promising new treatment for refractory OAB. It was deemed effective and safe at 12-month assessment. 

Presented by: Scott Avard MacDiarmid, MD; University of North Carolina

Written by: Hanna Stambakio, BS, Clinical Research Coordinator, Division of Urology, University of Pennsylvania @AStambakio at the American Urological Association's 2019 Annual Meeting (AUA 2019), May 3 – 6, 2019 in Chicago, Illinois
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