A prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the eCoin® implanted tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).
The goal of this prospective, multicenter, single-arm study is to assess the long-term safety and effectiveness of the FDA approved eCoin® implanted tibial nerve stimulator in a real world setting. Eligible subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI) will be implanted with the eCoin® implanted tibial stimulator and complete voiding diaries and questionnaires at follow-up visits through 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Subcutaneous stimulation of the tibial nerve using the eCoin device.
Urology Centers of Alabama
Homewood, Alabama, United States
Responder Rate
Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
Time frame: 12 months
Safety: 12 months rate of all device or procedure related AEs.
Rate of all device or procedure related AEs.
Time frame: 12 months
Responder Rate
Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
Time frame: 24 months
Safety Data
Rate of all device or procedure related AEs through 24 months post activation of eCoin.
Time frame: 24 months
Safety data through 7 months post-reimplantation.
Rate of device or procedure-related AEs through 7 months post reimplantation.
Time frame: 7 months post reimplantation
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USA Health
Mobile, Alabama, United States
WITHDRAWNArkansas Urology
Little Rock, Arkansas, United States
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