Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence

Not Applicable

Completed

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

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
eCoin Tibial Nerve Stimulation	eCoin Tibial Nerve Stimulation	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	24 weeks after device activation	Moderate-term effectiveness data, responder rate
Moderate-term Safety in All Patients. Percentage of Patients With Device or Implantation Related Adverse Events.	24 weeks after device activation	All adverse events will be reported.

Locations (14): Florida Bladder Institute
🇺🇸
Naples, Florida, United States
Manhattan Medical Research
🇺🇸
New York, New York, United States
Sequoia Urology Center
🇺🇸
Redwood City, California, United States
SurgOne PC
🇺🇸
Englewood, Colorado, United States
Adult & Pediatric Urology
🇺🇸
Omaha, Nebraska, United States
Kaiser Permanente
🇺🇸
San Diego, California, United States
Sansum Clinic
🇺🇸
Santa Barbara, California, United States
Urology Associates of Norwalk
🇺🇸
Norwalk, Connecticut, United States
North Shore Medical Group
🇺🇸
Skokie, Illinois, United States
Alliance Urology Specialists
🇺🇸
Greensboro, North Carolina, United States
South Carolina OB/GYN
🇺🇸
Columbia, South Carolina, United States
UnityPoint Clinic
🇺🇸
Waterloo, Iowa, United States
Chesapeake Urology
🇺🇸
Owings Mills, Maryland, United States
The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)
🇺🇸
Allentown, Pennsylvania, United States