CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 163 enrolled
Drug / intervention
(VERV™ System) +1 moredevice
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/NCT01369485
NCT01369485N/ACompleted
CompareCT.gov

Multi-center, Prospective, Randomized, Double-blind, Sham-controlled Clinical Study to Evaluate Safety and Effectiveness of a Transcutaneous, High-frequency, Amplitude-modulated, Non-invasive Neuromodulation Device on Urgency Urinary Incontinence in Subjects With Overactive Bladder (OAB)

Ethicon Endo-Surgery·interventional·Posted Jun 9, 2011·Updated Sep 11, 2014

In Brief

A clinical study evaluating (VERV™ System) and Sham version of (VERV™ System) for Overactive Bladder. Completed, enrolled 163 participants across 14 sites.

Detailed Summary

The purpose of this study is to evaluate the change from baseline between the active and sham treatment groups in the treatment of urgency (urinary) incontinence episodes (leaks).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder
CountriesUnited States
CollaboratorsNovella Clinical, Data & Inference, Inc.

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 9, 2011
Enrollment StartJun 1, 2011
Primary CompletionJan 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.1 years ago

Interventions

(VERV™ System)device

Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.

Sham version of (VERV™ System)device

Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.