Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence

Study Overview
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Brief Summary
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This trial is a prospective, multicenter, single-arm study of the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI). The study will evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient reported-outcomes through 48 weeks of eCoinTM therapy or 52 weeks of implantation.

Official Title
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Pivotal Study of Subcutaneous Tibial Nerve Stimulation With eCoin for Overactive Bladder (OAB) With Urgency Urinary Incontinence (UUI)

Conditions
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Overactive Bladder, Urge Incontinence, Incontinence, Urinary, Urinary Urge Incontinence

Intervention / Treatment
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* Device: eCoin Tibial Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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Primary Inclusion Criteria: Women and men between 18 and 80 years old. Diagnosis of overactive bladder with urgency urinary incontinence or mixed urge and stress incontinence with a predominant urgency component (selfreported), for at least 6 months. Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists). Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or percutaneous tibial nerve stimulation. Primary Exclusion Criteria: Predominant stress urinary incontinence with more than 1/3 stress urinary incontinent episodes when compared to total urinary incontinent episodes. Clinically significant bladder outlet obstruction. Clinically significant pelvic organ prolapse beyond the hymenal ring. Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eCoin Tibial Nerve Stimulation<br> | Device: eCoin Tibial Nerve Stimulation<br>* Subcutaneous stimulation of the tibial nerve using the eCoin device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. | Responder rate | 48 weeks after device activation. | 
| Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events. | All adverse events will be reported in all patients who were implanted 12 months after implantation. | 52 weeks after implantation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate-term Safety in All Patients. Percentage of Patients With Device or Implantation Related Adverse Events. | All adverse events will be reported. | 24 weeks after device activation | 
| Moderate-term Effectiveness Data. Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. | Moderate-term effectiveness data, responder rate | 24 weeks after device activation |