CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 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.

Search/NCT03655054
NCT03655054N/ACompleted
CompareCT.gov

SUBCUTANEOUS TIBIAL NERVE STIMULATION FOR URGENCY URINARY INCONTINENCE: A FOLLOW-ON STUDY

Valencia Technologies Corporation·interventional·Posted Aug 31, 2018·Updated Oct 17, 2022

In Brief

A clinical study evaluating eCoin Tibial Nerve Stimulation for Overactive Bladder and 3 related conditions. Completed, enrolled 23 participants across 7 sites in 2 countries.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder, Urge Incontinence, Incontinence, Urinary, Urinary Urge Incontinence
CountriesNew Zealand, United States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 31, 2018
Enrollment StartMar 13, 2019
Primary CompletionJan 31, 2020
Study CompletionSep 12, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.8 years ago

Interventions

eCoin Tibial Nerve Stimulationdevice

Subcutaneous stimulation of the tibial nerve using the eCoin device.