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Published on: January 10, 2013
Two-year Pivotal Study Analysis of the Safety and Efficacy of Implantable Tibial Nerve Stimulation With eCoin® for
Vincent Lucente1, Laura Giusto2, Scott MacDiarmid3
1Division of Gynecology, Chief Section of Urogynecology, St. Luke's University Health Network, Baltimore, MD.
Objective:
To evaluate the continued effectiveness and safety of the eCoin Implantable Tibial Nerve Stimulator system (ITNS) for urgency urinary incontinence (UUI) in patients with overactive bladder (OAB). The 1-year pivotal study was extended through 2 years. The ITNS is a novel and recently FDA-approved therapy.
Methods:
A prospective, multicenter, single-arm trial was conducted on 137 subjects with refractory UUI to evaluate eCoin ITNS therapy. A 3-day voiding diary was collected along with the OAB questionnaire, Patient Global Impression of Improvement, and a custom Likert scale on subject satisfaction. The primary efficacy measure was the proportion of subjects who achieved at least 50% reduction from baseline in number of UUI episodes. The primary safety measure was device-related adverse events (AEs).
Results:
Seventy-two subjects completed the 96-week evaluation. Around 78% (95% CI: 67%-87%) experienced at least 50% reduction in UUI episodes; 48% (95% CI, 36%-60%) experienced at least 75% reduction, and 22% (95% CI, 13%-33%) were dry on a 3-day diary. Subjects reported a decrease from baseline in their UUI episodes/day of 2.61 (SD 2.97) and 2.97 (SD 2.64) at 48 weeks and 96 weeks, respectively. Around 91.3% did not require additional medications for OAB. No serious or unanticipated AEs were reported in this extension phase.
Conclusion:
The eCoin ITNS demonstrated consistent continuing effectiveness and safety in treating OAB patients with UUI. The findings support it as an excellent treatment option for refractory patients.
