Effectiveness of eCoin at Sensory and Subsensory Amplitudes (NCT05882318) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of eCoin at Sensory and Subsensory Amplitudes
United States38 participantsStarted 2023-06-06
Plain-language summary
The goal of this prospective, multi-center, double-blinded randomized controlled is to learn about effectiveness and QOL with eCoin at two different amplitude settings in subjects with urge urinary incontincence (UUI). The main question it aims to answer is:
* The reduction in UUI episodes per day on a 3-day voiding diary in both groups after 3 months of therapy
Participants will be implanted with the eCoin device and randomized to either a sensory or subsensory stimulation group and complete voiding diaries and patient reported-outcomes through 3 months of therapy. After 3 months, subjects will be unblinded and reprogramming will be offered. Subjects will be followed for an additional month to a total of 4 months.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Individual with diagnosis of overactive bladder with urgency urinary incontinence - daily UUI with a predominantly urgency component
✓. Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or who have undergone percutaneous tibial nerve stimulation (PTNS).
✓. Individual is determined to be a suitable surgical candidate by physician.
Exclusion criteria
✕. Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements.
✕. Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on baseline diary are stress).
✕. Individual has clinically significant bladder outlet obstruction.
✕. Individual has an active urinary tract infection at time of enrollment or has had four or more symptomatic UTI's in the last 12 months.
✕. Individual has significant lower urinary tract pain or has been diagnosed with interstitial cystitis or bladder pain syndrome that is actively being managed.