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