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NCT01369485 · ClinicalTrials.gov registry record · NA
Safety and Effectiveness of a Non-invasive Neuromodulation Device on Urgency Urinary Incontinence in Overactive Bladder
A NA study, sponsored by Ethicon Endo-Surgery.
- Completed
- Registry status
- NA
- Development phase
- 163
- Enrollment target
NCT01369485: Completed NA study, sponsored by Ethicon Endo-Surgery.
NCT01369485 is a NA study that has completed, run by Ethicon Endo-Surgery. The registered enrollment target is 163 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01369485, a NA study, has completed, sponsored by Ethicon Endo-Surgery.
- COMPLETED
- Registry status
- NA
- Development phase
- 163 participants
- Enrollment target
Study 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).
Primary Outcome
The primary objective of the randomized phase of the study is to evaluate the 12 week change from baseline in mean urgency (urinary) incontinence episodes (leaks) between the active and sham treatment groups. The mean of the number of urinary incontinence episodes over 24 hours" is defined as the mean of the number of UIEs recorded per 24 hour period for three consecutive days (via a 3-day diary). The primary objective of the open label phase of the study is to evaluate and confirm the continue
Interventions
- DEVICE (VERV™ System)
- DEVICE Sham version of (VERV™ System)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-12 |
| Phase | NA |
What the finished NCT01369485 record still lists
NCT01369485 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which (VERV™ System) is the first listed.
NCT01369485 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01369485 about?
NCT01369485 is a clinical study titled "Safety and Effectiveness of a Non-invasive Neuromodulation Device on Urgency Urinary Incontinence in Overactive Bladder". 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).
What is the current status of trial NCT01369485?
This trial is currently completed. It is a NA study. The enrollment target is 163 participants. The study started on 2011-06. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01369485?
The interventions under investigation include: (VERV™ System) (DEVICE), Sham version of (VERV™ System) (DEVICE).
Who is sponsoring clinical trial NCT01369485?
This trial is sponsored by Ethicon Endo-Surgery, which has 39 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01369485's enrollment target sits among peer trials
163 627th of 2000 higher than 1,374 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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