Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence

Valencia Technologies

Status: Active, not recruiting

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

Treatments: Device: eCoin Tibial Nerve Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03556891

111-3281

Details and patient eligibility

About

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.

Enrollment: 133 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Primary Inclusion Criteria:

1. Women and men between 18 and 80 years old.
2. 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.
3. Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists).
4. 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:

1. Predominant stress urinary incontinence with more than 1/3 stress urinary incontinent episodes when compared to total urinary incontinent episodes.
2. Clinically significant bladder outlet obstruction.
3. Clinically significant pelvic organ prolapse beyond the hymenal ring.
4. Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

133 participants in 1 patient group

eCoin Tibial Nerve Stimulation

Experimental group

Treatment:

Device: eCoin Tibial Nerve Stimulation