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Tibial Nerve Stimulation

eCoin for Overactive Bladder

N/A

Waitlist Available

Led By Scott MacDiarmid, MD

Research Sponsored by Valencia Technologies Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of overactive bladder with urgency urinary incontinence or mixed urge and stress incontinence with a predominant urgency component (self-reported), for at least 6 months

Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists)

Must not have

Predominant stress urinary incontinence with more than 1/3 stress urinary incontinent episodes when compared to total urinary incontinent episodes

Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks after device activation

Awards & highlights

No Placebo-Only Group

Summary

This trialstudies the safety & effectiveness of a nerve stimulator for treating OAB/UUI symptoms. It evaluates changes from baseline in OAB symptoms for up to 48/52 weeks.

Who is the study for?

This trial is for men and women aged 18-80 with overactive bladder (OAB) and urgency urinary incontinence who haven't had success with standard treatments like anticholinergics or Botox. Participants should not be on OAB medication currently and must have been dealing with symptoms for at least six months.

What is being tested?

The eCoin Tibial Nerve Stimulation device is being tested to see if it can help control the symptoms of an overactive bladder. This single-arm study will track changes in participants' bladder activity through diaries and questionnaires for up to one year after implantation.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, skin irritation or infection, inflammation, allergic reactions to the device materials, or unintended impacts on bladder function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had overactive bladder symptoms for at least 6 months.

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I am not taking medication for overactive bladder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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Most of my urinary leaks happen when I cough, sneeze, or exercise.

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I have healthy skin on both of my lower legs without signs of infection or inflammation.

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I have a significant blockage in my bladder.

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My pelvic organs have dropped below the vaginal opening.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks after device activation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks after device activation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks after device activation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.

Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.

Secondary study objectives

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 Safety in All Patients. Percentage of Patients With Device or Implantation Related Adverse Events.