A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorValencia Technologies Corporation
About this trial
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).
Eligibility criteria
Qualifiers
Women and men above 18 years old with gender percentages reflective of disease prevalence in the U.S. population
Individual with diagnosis of overactive bladder with urgency urinary incontinence.
Individual has at least one urgency urinary incontinence episode on each of three days as determined on a 3-day voiding diary.
Individual gives written informed consent.
Disqualifiers
Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements.
Individual has clinically significant bladder outlet obstruction. (Suspected bladder outlet obstruction will be initially assessed by uroflow study with those having a maximum flow rate < 15mL/s requiring additional evaluation.)
Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on baseline diary are stress).
Individual has an active urinary tract infection at time of enrollment.
Trial design
Treatments tested in this trial
- eCoin Tibial Nerve Stimulation
Treatment groups
200 Participants
are divided into 1 treatment groupLocations
22Alabama
Urology Centers of Alabama35209, Homewood United States
USA Health36606, Mobile United States
Arkansas
Arkansas Urology72211, Little Rock United States
California
University of California, Irvine92697, Irvine United States
Sponsors and collaborators
Valencia Technologies Corporation
Lead sponsor
Source ClinicalTrials.gov