This trial is a prospective, multicenter, single-arm follow-on study will evaluate the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects with urgency urinary incontinence (UUI) as defined by the American Urological Association (30). The follow-on study will evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient-reported outcomes through 24 weeks of eCoinTM therapy (which is the same as 28 weeks from study device reimplantation).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Subcutaneous stimulation of the tibial nerve using the eCoin device.
The Clark Center for Urogynecology
Newport Beach, California, United States
UnityPoint Clinic
Waterloo, Iowa, United States
Alliance Urology Specialists
Greensboro, North Carolina, United States
The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)
Allentown, Pennsylvania, United States
Urology Associates
Christchurch, New Zealand
Roundhay Medical Centre
Nelson, New Zealand
Tauranga Urology Research Ltd
Tauranga, New Zealand
Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Time frame: 12 weeks after device activation.
Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 4 Months After Implantation.
Instances of a related adverse event.
Time frame: 16 weeks after device implantation.
Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Time frame: 24 weeks after device activation.
Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 6 Months After Implantation.
Instances of a related adverse event
Time frame: 28 weeks after device implantation.
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