Actively Recruiting
A Real World Study of eCoin for Urgency Urinary Incontinence Post Approval Evaluation RECIPE
Led by Valencia Technologies Corporation · Updated on 2026-01-28
200
Participants Needed
22
Research Sites
248 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the long-term safety and effectiveness of the FDA-approved eCoin4 implanted tibial nerve stimulator in people with overactive bladder OAB who experience urgency urinary incontinence UUI. The study is prospective, involves multiple centers, and follows a single group of participants to understand how the device performs in real-world use. Participants will receive an implant of the eCoin device, which provides subcutaneous stimulation to the tibial nerve. This stimulation is intended to help manage urgency urinary incontinence. The treatment involves implanting the device and then monitoring participants over time to evaluate its safety and effectiveness. Throughout the study, participants will complete voiding diaries and quality of life questionnaires during follow-up visits that extend up to 5 years. Researchers will monitor safety by tracking any device- or procedure-related adverse events and measure effectiveness by assessing responder rates at 12 and 24 months. The study includes ongoing evaluations of safety data even after reimplantation when applicable, ensuring comprehensive long-term monitoring.
CONDITIONS
Brief Title
A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women and men above 18 years old with gender percentages reflective of disease prevalence in the U.S. population
- Diagnosis of overactive bladder with urgency urinary incontinence
- At least one urgency urinary incontinence episode on each of three days as recorded in a 3-day voiding diary
- Written informed consent provided
- Mentally competent and able to understand all study requirements
- Willing and able to complete a 3-day voiding diary and quality of life questionnaire
- Without pharmacological treatment for overactive bladder for at least 2 weeks prior to baseline or longer if therapeutic effect persists
- Intolerant of or inadequate response to anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or previous percutaneous tibial nerve stimulation
- Suitable surgical candidate as determined by physician
- Appropriate for eCoin treatment based on US FDA-approved instructions for use
You will not qualify if you...
- Not appropriate for eCoin therapy based on US FDA-approved instructions for use
- Clinically significant bladder outlet obstruction
- Predominant stress urinary incontinence (more than one-third of leaks on baseline diary)
- Active urinary tract infection at enrollment
- Known polyuria
- Significant lower urinary tract pain or diagnosis of interstitial cystitis or bladder pain syndrome
- Abnormal post void residual volume greater than 200 cc
- Clinically significant urethral stricture disease or bladder neck contracture
- Chronic venous insufficiency with ankle skin changes
- Morbid obesity judged unsuitable for study
- History of bladder, urethral, or prostate cancer
- Anti-stress incontinence sling surgery within the last year
- Pregnant or planning pregnancy during study
- Presence of urinary fistula, bladder stone, or interstitial cystitis
- Uncontrolled diabetes mellitus with Hemoglobin A1C greater than 7 or diabetes with significant complications
- Implantable neurostimulator, pacemaker, or implantable cardiac defibrillator
- Treatment with onabotulinumtoxinA within 9 months before enrollment unless therapeutic effect absent
- Percutaneous tibial nerve stimulation within 4 weeks before enrollment unless therapeutic effect absent
- Current use of transcutaneous electrical nerve stimulation in pelvic region, back, or legs
- Need for MRI scan other than head/neck/shoulder during study
- Clotting or bleeding disorders or anticoagulant therapy judged unsuitable
- Neutropenic or immune-compromised
- Previous surgery or significant scarring at implant site
- Ongoing dermatologic condition at implant site
- Clinically significant peripheral neuropathy in lower extremities
- Neurogenic bladder dysfunction
- Pitting edema at implant location of grade 2 or higher
- Inadequate skin integrity or infection/inflammation in lower leg
- Symptomatic varicose veins
- Open wounds, trauma, or prior surgery in lower extremities
- Arterial disease or vasculitis in lower extremities
- Bladder stones or neoplasia
- Any condition judged by investigator to make participant unsuitable for study
Research Team
D
Dylan Beyer
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