At a glance
ClinicalIndex Comparison RecordN/ACompleted· 133 enrolled
Drug / intervention
eCoin Tibial Nerve Stimulationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pivotal Study of Subcutaneous Tibial Nerve Stimulation With eCoin for Overactive Bladder (OAB) With Urgency Urinary Incontinence (UUI)
In Brief
A clinical study evaluating eCoin Tibial Nerve Stimulation for Overactive Bladder and 3 related conditions. Completed, enrolled 133 participants across 15 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 2018
Enrollment StartSep 2018
Primary CompletionApr 2020
Study CompletionSep 2024
TodayJul 2026
First PostedJun 14, 2018
Enrollment StartSep 4, 2018
Primary CompletionApr 12, 2020
Study CompletionSep 18, 2024
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.0 years ago
Interventions
eCoin Tibial Nerve Stimulationdevice
Subcutaneous stimulation of the tibial nerve using the eCoin device.