A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
Valencia Technologies Corporation
Summary
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).
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Individual is mentally competent and able to understand all study requirements. * Individual is willing and able to complete a 3-day voiding diary and quality of life questionnaire. * Individual is witho…
Interventions
- DeviceeCoin Tibial Nerve Stimulation
Subcutaneous stimulation of the tibial nerve using the eCoin device.
Locations (22)
- Urology Centers of AlabamaHomewood, Alabama
- USA HealthMobile, Alabama
- Arkansas UrologyLittle Rock, Arkansas
- University of California, IrvineIrvine, California
- AIR ResearchLos Angeles, California
- Stanford HealthStanford, California