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NCT01125722 · ClinicalTrials.gov registry record · NA
Clinical Trial to Study a Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence Overactive Bladder (OAB)
A NA study of Overactive Bladder, sponsored by Ethicon Endo-Surgery.
- Completed
- Registry status
- NA
- Development phase
- 74
- Enrollment target
- 11
- Study locations
NCT01125722: Completed NA study of Overactive Bladder, sponsored by Ethicon Endo-Surgery.
NCT01125722 is a NA study of Overactive Bladder that has completed, run by Ethicon Endo-Surgery. The registered enrollment target is 74 participants, below the 206-participant average among 46 other Overactive Bladder trials with a reported enrollment target (64% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01125722, a NA study of Overactive Bladder, has completed, sponsored by Ethicon Endo-Surgery.
- COMPLETED
- Registry status
- NA
- Development phase
- 74 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of this study is to determine whether the non-invasive neurostimulation patch is effective in the treatment of urgency, frequency and urge (urinary) incontinence.
Primary Outcome
Mean urgency incontinence episodes (or urinary leaks) over 24 hours is based on a 3-day diary maintained by the subject. Urgency incontinence is when a subject has urinary leakage, i.e., uncontrolled release of fluid prior to making it to the bathroom. The number of leaks over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.
Conditions Studied
Interventions
- DEVICE Non-invasive neurostimulation device
Study Locations (11)
New Jersey
- AdvanceMed Research - Lawrenceville
- Delaware Valley Urology, LLC - Mount Laurel
North Carolina
- McKay Urology - Charlotte
- Alliance Urology Specialists, P.A. - Greensboro
Other
- Danderyd University Hospital - Stockholm
- Princess Anne Hospital - Southampton
District of Columbia
- Medical Faculty Associates, The George Washington University - Washington D.C.
Michigan
- William Beaumont Hospital - Department of Urology - Royal Oak
South Carolina
- Medical University of South Carolina - Charleston
Tennessee
- Vanderbilt University Medical Center - Nashville
Wisconsin
- Wheaton Franciscan Medical Group, Milwaukee Urogynecology - Wauwatosa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2010-04 |
| Est. Completion | 2011-03 |
| Phase | NA |
What the finished NCT01125722 record still lists
NCT01125722 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 206-participant average among 46 other Overactive Bladder trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Overactive Bladder appearing as the primary indexed condition, and to 1 intervention - of which Non-invasive neurostimulation device is the first listed.
NCT01125722 lists 11 locations in 8 states (New Jersey, North Carolina, Other).
Frequently Asked Questions
What is clinical trial NCT01125722 about?
NCT01125722 is a clinical study titled "Clinical Trial to Study a Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence Overactive Bladder (OAB)". The purpose of this study is to determine whether the non-invasive neurostimulation patch is effective in the treatment of urgency, frequency and urge (urinary) incontinence.
What is the current status of trial NCT01125722?
This trial is currently completed. It is a NA study. The enrollment target is 74 participants. The study started on 2010-04. Estimated completion is 2011-03.
What conditions does trial NCT01125722 study?
This clinical trial studies the following conditions: Overactive Bladder.
What interventions are being tested in trial NCT01125722?
The interventions under investigation include: Non-invasive neurostimulation device (DEVICE).
Who is sponsoring clinical trial NCT01125722?
This trial is sponsored by Ethicon Endo-Surgery, which has 39 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01125722 being conducted?
This trial has 11 study locations across District of Columbia, Michigan, New Jersey, North Carolina, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01125722's enrollment target sits among peer trials
74 30th of 46 higher than 17 of 46 other Overactive Bladder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Overactive Bladder 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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