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. After 3 months, subjects will be unblinded and reprogramming will be offered. Subjects will be followed for an additional month to a total of 4 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
38
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.
Genesis Research
Downey, California, United States
Urology Associates of Central California
Fresno, California, United States
The Iowa Clinic
Ankeny, Iowa, United States
Cypress Medical Research Center
Wichita, Kansas, United States
Adult & Pediatric Urology P.C.
Omaha, Nebraska, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, United States
Institute for Female Pelvic Medicine
Allentown, Pennsylvania, United States
Change in UUI Episodes Per Day
The primary endpoint is to explore the effect of two different eCoin amplitude settings on the change of UUI episodes per day on a 3-day voiding diary. A negative number shows a reduction in UUI episodes per day which means symptoms have improved since baseline. A positive number shows an increase in UUI episodes per day which means symptoms have worsened since baseline.
Time frame: 3 months post-activation
Change in UUI Episodes Per Day
Change in the number of urgency urinary incontinence episodes per day on a 3-day voiding diary. A negative number shows a reduction in UUI episodes which means symptoms have improved since baseline. A positive number shows an increase in UUI episodes per day which means symptoms have worsened since baseline.
Time frame: 2 months post-activation
Change in UUI Episodes Per Day
A secondary endpoint is to explore the change in UUI episodes per day on a 3-day voiding diary. A negative number shows a reduction in UUI episodes per day which means symptoms have improved since baseline. A positive number shows an increase in UUI episodes per day which means symptoms have worsened since baseline.
Time frame: 4 months post-activation
Change in Overactive Bladder Health Related Quality of Life (HRQL)
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. The maximum HRQL domain score is 100 (best) and the minimum HRQL score is 0 (worst). A positive change in score indicates an improvement in quality of life.
Time frame: 2 and 3 months post-activation
Change in Overactive Bladder Health Related Quality of Life (HRQL)
Change from baseline in 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 indicate better quality of life. The maximum HRQL domain score is 100 (best) and the minimum HRQL score is 0 (worst). A positive change in score indicates an improvement in quality of life.
Time frame: 4 months post-activation
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