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A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)

UCI Specialty Area: Urology
Principal Investigator: Dena Moskowitz
Official Title: A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
A Study On:
Genital Bladder - Genitourinary
Urinary Incontinence

Study Description

Participants will be implanted with eCoin ® and complete voiding diaries and patient reported-outcomes through 12 months of eCoin ® therapy.

Eligibility

Inclusion Criteria:

  1. Women and men above 18 years old with gender percentages reflective of disease prevalence in the U.S. population
  2. Individual with diagnosis of overactive bladder with urgency urinary incontinence.
  3. Individual has at least one urgency urinary incontinence episode on each of three days as determined on a 3-day voiding diary.
  4. Individual gives written informed consent.
  5. Individual is mentally competent and able to understand all study requirements.
  6. Individual is willing and able to complete a 3-day voiding diary and quality of life questionnaire.
  7. Individual is without pharmacological treatment of overactive bladder for 2 weeks prior to baseline or longer if the physician judges that the therapeutic effect is still present.
  8. Individual is intolerant of or has an inadequate response to any of anticholinergics, 3-adrenoceptor agonists, onabotulinumtoxinA, or who have undergone percutaneous tibial nerve stimulation (PTNS).
  9. Individual is determined to be a suitable surgical candidate by physician.
  10. Individual is appropriate for eCoin treatment based on the US FDA-approved IFU requirements.

Other Protocol defined inclusion/ exclusion criteria may apply

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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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