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NCT03278613 · ClinicalTrials.gov registry record · NA
Neuromodulation for Accidental Bowel Leakage
A NA study, sponsored by NICHD Pelvic Floor Disorders Network.
- Completed
- Registry status
- NA
- Development phase
- 166
- Enrollment target
NCT03278613: Completed NA study, sponsored by NICHD Pelvic Floor Disorders Network.
NCT03278613 is a NA study that has completed, run by NICHD Pelvic Floor Disorders Network. The registered enrollment target is 166 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
NCT03278613, a NA study, has completed, sponsored by NICHD Pelvic Floor Disorders Network.
- COMPLETED
- Registry status
- NA
- Development phase
- 166 participants
- Enrollment target
Study Summary
This study is a multi-center, randomized clinical trial of women with refractory accidental bowel leakage (ABL) symptoms who have failed to achieve satisfactory symptom control from 2 first-line treatments for ABL: supervised pelvic muscle training (PMT) and constipating medication. The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to a validated sham to determine if PTNS is effective for the treatment of fecal incontinence (FI) in women. The investigators will test the null hypothesis that change from baseline in St. Mark's (Vaizey) score after 12 weeks of stimulation is not significantly different in women with symptomatic ABL receiving PTNS treatments compared to women receiving sham PTNS treatments.
Primary Outcome
The primary outcome measure is the change from baseline in St. Mark's (Vaizey) Score 12 weeks after treatment initiation to compare the outcomes of post-tibial nerve stimulation (PTNS) versus sham stimulation. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continen
Interventions
- DEVICE ES-130
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2018-02-09 |
| Est. Completion | 2020-03-09 |
| Phase | NA |
What the finished NCT03278613 record still lists
NCT03278613 is an interventional study that assigns participants to a tested intervention. The registered 166 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 1 intervention - of which ES-130 is the first listed.
NCT03278613 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03278613 about?
NCT03278613 is a clinical study titled "Neuromodulation for Accidental Bowel Leakage". This study is a multi-center, randomized clinical trial of women with refractory accidental bowel leakage (ABL) symptoms who have failed to achieve satisfactory symptom control from 2 first-line treatments for ABL: supervised pelvic muscle training (PMT) and constipating medication. The purpose of t...
What is the current status of trial NCT03278613?
This trial is currently completed. It is a NA study. The enrollment target is 166 participants. The study started on 2018-02-09. Estimated completion is 2020-03-09.
What interventions are being tested in trial NCT03278613?
The interventions under investigation include: ES-130 (DEVICE).
Who is sponsoring clinical trial NCT03278613?
This trial is sponsored by NICHD Pelvic Floor Disorders Network, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03278613's enrollment target sits among peer trials
166 625th of 2000 higher than 1,375 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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