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NCT03543566 · ClinicalTrials.gov registry record
Bladder Antimuscarinic Medication and Accidental Bowel Leakage
A clinical trial of Fecal Incontinence and Urinary Incontinence, Urge, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- 32
- Enrollment target
- 1
- Study location
NCT03543566: Completed study of Fecal Incontinence and Urinary Incontinence, Urge, sponsored by University of Alabama at Birmingham.
NCT03543566 is a study of Fecal Incontinence and Urinary Incontinence, Urge that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 32 participants, below the 334-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03543566, a study of Fecal Incontinence and Urinary Incontinence, Urge, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
This observational research study will examine whether a medication known as darifenacin (Enablex ®) used for urgency urinary incontinence (UUI) also helps to improve fecal incontinence symptoms. Darifenacin is FDA approved for UUI, but is not FDA approved for fecal incontinence or specifically for dual incontinence (treatment of urinary incontinence and fecal incontinence at the same time). If participants are eligible for this study, they will have had symptoms of bothersome urgency urinary incontinence and fecal incontinence, and have decided to try medication for urgency urinary incontinence. Darifenacin (Enablex ®) is an oral medication which relaxes the bladder muscle to help prevent urgency urinary leakage. It is commonly used to treat overactive bladder and urgency urinary leakage. There is some evidence that this medication may also help with fecal incontinence by slowing the gut and preventing loose stools. Investigators are planning to enroll approximately 30 patients who have both UUI and fecal incontinence and who choose medical treatment as a part of their standard care.
Primary Outcome
to be measured by questionnaire and bowel diary Questionnaire to be used is the Vaizey scale which measures fecal incontinence severity. Minimum score is 0 (perfect continence; best) and maximum score is 24 (total incontinence; worse). There is no subscale. Bowel diary is a weeklong record of each bowel movement the patient has. there is no standardized scoring or scale.
Conditions Studied
Study Locations (1)
Alabama
- UAB Kirklin Clinic - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2018-05-21 |
| Est. Completion | 2019-01-18 |
What the finished NCT03543566 record still lists
NCT03543566 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 334-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Fecal Incontinence appearing as the primary indexed condition, and to 0 interventions.
NCT03543566 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT03543566 about?
NCT03543566 is a clinical study titled "Bladder Antimuscarinic Medication and Accidental Bowel Leakage". This observational research study will examine whether a medication known as darifenacin (Enablex ®) used for urgency urinary incontinence (UUI) also helps to improve fecal incontinence symptoms. Darifenacin is FDA approved for UUI, but is not FDA approved for fecal incontinence or specifically for ...
What is the current status of trial NCT03543566?
This trial is currently completed. The enrollment target is 32 participants. The study started on 2018-05-21. Estimated completion is 2019-01-18.
What conditions does trial NCT03543566 study?
This clinical trial studies the following conditions: Fecal Incontinence, Urinary Incontinence, Urge.
Who is sponsoring clinical trial NCT03543566?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03543566 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03543566's enrollment target sits among peer trials
32 15th of 22 higher than 8 of 22 other Fecal Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fecal Incontinence 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.
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