eCoin for OAB Feasibility Follow-on Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-13

Study Completion Date

2022-09-12

Brief Summary

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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).

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Detailed Description

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Conditions

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Overactive Bladder Urge Incontinence Incontinence, Urinary Urinary Urge Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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eCoin Tibial Nerve Stimulation

Group Type EXPERIMENTAL

eCoin Tibial Nerve Stimulation

Intervention Type DEVICE

Subcutaneous stimulation of the tibial nerve using the eCoin device.

Interventions

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eCoin Tibial Nerve Stimulation

Subcutaneous stimulation of the tibial nerve using the eCoin device.

Intervention Type DEVICE

Eligibility Criteria

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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.