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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 is a NA study that has completed, run by NICHD Pelvic Floor Disorders Network. The registered enrollment target is 166 participants.
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.
Interventions
- DEVICE ES-130
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2018-02-09 |
| Est. Completion | 2020-03-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03278613
The ClinicalTrials.gov registry entry for NCT03278613 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 166 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Pelvic Floor Disorders Network, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ES-130 is the first listed.
NCT03278613 reports 0 study locations.
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.
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