Overactive Bladder clinical trials at UC Irvine

The goal of this prospective, multicenter, single-arm study is to test the safety and effectiveness of eCoin ® tibial nerve stimulation in subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI). The main questions it aims to answer are: - The proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary (72 hours) after 12 months of therapy. - The rate of device- or procedure-related AEs through 12 months post-activation of eCoin ®. Participants will be implanted with eCoin ® and complete voiding diaries and patient reported-outcomes through 12 months of eCoin ® therapy.

This is a prospective, randomized, controlled, multi-center, study in which 150 evaluable subjects will be randomized 1:1 to receive either a Protect CAN-Stim or SNS InterStim® system. Subjects from both groups will immediately start with therapy. The primary endpoint is a ≥ 50% reduction in number of incontinence episodes associated with urgency at the 3-month visit, with additional measurements assessed at 14 days, 1, 6, 9 and 12-months.