eCoin for OAB Feasibility Follow-on Study

Valencia Technologies

Status: Completed

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

Treatments: Device: eCoin Tibial Nerve Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03655054

111-3335

Details and patient eligibility

About

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).

Enrollment: 23 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Individual participated in the eCoin Feasibility Study for Urgency Urinary Incontinence.
2. Individual was implanted with the study device during the eCoin Feasibility Study for Urgency Urinary Incontinence.

Exclusion criteria

1. In the opinion of the investigator, individual is not a good candidate for participation in the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

eCoin Tibial Nerve Stimulation

Experimental group

Treatment:

Device: eCoin Tibial Nerve Stimulation