Effectiveness of eCoin at Sensory and Subsensory Amplitudes

Study Overview
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Brief Summary
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The goal of this prospective, multi-center, double-blinded randomized controlled is to learn about effectiveness and QOL with eCoin at two different amplitude settings in subjects with urge urinary incontincence (UUI). The main question it aims to answer is: The reduction in UUI episodes per day on a 3-day voiding diary in both groups after 3 months of therapy Participants will be implanted with the eCoin device and randomized to either a sensory or subsensory stimulation group and complete voiding diaries and patient reported-outcomes through 3 months of therapy.

Official Title
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Evaluating Effectiveness of Sensory and Subsensory Stimulation Amplitudes With eCoin® Tibial Nerve Stimulation in Urgency Urinary InContinence Episodes and Quality of Life

Conditions
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Urge Incontinence

Intervention / Treatment
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* Device: eCoin Peripheral Neurostimulator System


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Individual with diagnosis of overactive bladder with urgency urinary incontinence - daily UUI with a predominantly urgency component 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. Key Exclusion Criteria: Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements. Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on baseline diary are stress). Individual has clinically significant bladder outlet obstruction. Individual has an active urinary tract infection at time of enrollment or has had four or more symptomatic UTI's in the last 12 months. Individual has significant lower urinary tract pain or has been diagnosed with interstitial cystitis or bladder pain syndrome that is actively being managed. Individual has post void residual greater than 200 cc. Individual has an active diagnosis of bladder, urethral, or prostate cancer. Individual has had a prior anti-stress incontinence surgery within the last year. Individual has uncontrolled diabetes mellitus (Hemoglobin A1C>7). Individual is neutropenic or immune-compromised. Individual has lower extremity pathology such as: Previous surgery and/or significant scarring at the planned implant location Ongoing dermatologic condition at the implant site, including but not limited to dermatitis and autoimmune disorders Clinically significant peripheral neuropathy in the lower extremities Pitting edema at the implant location (≥ 2+ is excluded) Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg Moderate to severe varicose veins Open wounds or recent trauma Arterial and/or vasculitis disease in the lower extremities Chronic venous insufficiency with a history of skin change (hyperpigmentation, lipodermatosclerosis, ulceration) in the ankle region Individual has neurogenic bladder dysfunction. Individual is aware that he or she will need an MRI scan other than a head/neck/shoulder MRI during the study period. Any condition that, in the investigator's opinion, would preclude participation in the study (e.g., comorbidity that places subject at increased risk for surgical intervention, medical condition that may increase the risk associated with study participation or may interfere with interpretation of study results, inability to adhere to the visit schedule, such as morbid obesity, clotting or bleeding disorder)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sensory<br> | Device: eCoin Peripheral Neurostimulator System<br>* The eCoin device is a leadless, coin-sized tibial neurostimulator for treatment of urgency urinary incontinence. It emits a dome-shaped electrical field to deliver low-duty cycle stimulation to the tibial nerve. The device is to be implanted under local anesthetic in the lower leg, and once activated delivers automatic 30-minute treatment sessions without the need for patient management.<br>|
| Experimental: Subsensory<br> | Device: eCoin Peripheral Neurostimulator System<br>* The eCoin device is a leadless, coin-sized tibial neurostimulator for treatment of urgency urinary incontinence. It emits a dome-shaped electrical field to deliver low-duty cycle stimulation to the tibial nerve. The device is to be implanted under local anesthetic in the lower leg, and once activated delivers automatic 30-minute treatment sessions without the need for patient management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in UUI Episodes | The primary endpoint is to explore the effect of two different eCoin amplitude settings on the reduction of UUI episodes per day on a 3-day voiding diary | 3 months post-activation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life with OABq | Change from baseline in the patient reported quality of life as assessed by the Health Related Quality of Life (HRQL) portion of the Overactive Bladder questionnaire (OABq) survey Higher scores on the HRQL portion indicate better quality of life. | 2, 3 and 4 months post-activation | 
| Patient Satisfaction | Improvement from baseline of patient satisfaction with UUI symptoms as gathered from patient satisfaction surveys | 2, 3 and 4 months post-activation | 
| Reduction in UUI Episodes | Reduction from baseline in the number of urgency urinary incontinence episodes per day on a 3-day voiding diary (72 hours) | 2 and 4 months post-activation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuromodulation, eCoin device, Stimulation, Tibial nerve