Evaluating Effectiveness of Sensory and Subsensory Stimulation Amplitudes With eCoin® Tibial Nerve Stimulation in Urgency Urinary InContinence Episodes and Quality of Life
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Urge Incontinence
- Sponsor
- Valencia Technologies Corporation
- Enrollment
- 38
- Locations
- 7
- Primary Endpoint
- Change in UUI Episodes Per Day
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Change in UUI Episodes Per Day
Time Frame: 3 months post-activation
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.
Secondary Outcomes
- Change in UUI Episodes Per Day(4 months post-activation)
- Change in Overactive Bladder Health Related Quality of Life (HRQL)(4 months post-activation)