CompletedNot Applicable

Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence

United States133 participantsStarted 2018-09-04

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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.

What they're measuring

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

Timeframe: 48 weeks after device activation.

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

Timeframe: 52 weeks after implantation.

Trial details

NCT IDNCT03556891

SponsorValencia Technologies Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-04-12

Results submitted2021-06-18

View on ClinicalTrials.gov More Overactive Bladder trials