Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Bladder Antimuscarinic Medication and Accidental Bowel Leakage
NCT03543566 · View on ClinicalTrials.gov ↗
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.
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03543566
The ClinicalTrials.gov registry entry for NCT03543566 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,315 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Fecal Incontinence appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03543566 reports 1 study location spanning 1 distinct geographic area — top geographies include Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT03543566?
This trial is sponsored by University of Alabama at Birmingham, which has 1,315 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.