A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
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).
• 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 without pharmacological treatment of overactive bladder (anticholinergic and β3-adrenoceptor agonists) for 2 weeks prior to baseline or longer if the physician judges that the therapeutic effect is still present.
• 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.
• Individual is appropriate for eCoin treatment based on the US FDA-approved IFU requirements.