Bladder Antimuscarinic Medication and Accidental Bowel Leakage

Completed

Conditions studied: Urinary Incontinence, Urge, Fecal Incontinence

In brief

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.

Key facts

Study ID

NCT03543566

Run by

University of Alabama at Birmingham

People needed

32

Starts

2018-05-21

Expected to finish

2019-01-18

Last updated by the study team

2019-01-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women ≥18yrs presenting to UAB urogynecology and continence clinics with co-occurring UUI and FI
• Willing to complete all study related items

You may not qualify if…

• Severe constipation, fecal impaction or overflow fecal incontinence
• Inflammatory bowel disease, colorectal CA, spinal cord injury, multiple sclerosis, stroke, myasthenia gravis
• Infectious diarrhea
• Bothersome SUI (defined as "moderately" or greater bother on UDI-3)
• Patients planning to undergo surgery during study period
• Patients who are pregnant or intending to become pregnant during the study period
• Patients with contraindications to antimuscarinic medications (ie. closed angle glaucoma)
• Patients on unstable or changing dosage of fiber or narcotics in the past 14 days
• Patients taking more than 2mg/day of loperamide (patients taking more than 2mg will be required a 2 week washout period)
• Patients currently taking medication for urgency urinary incontinence (these patients will also require a 2 week washout period)
• Patients initiating care with a pelvic floor physical therapist during the study period

Where it is running

• UAB Kirklin Clinic — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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