Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT03543566
Eligibility Criteria:
Inclusion Criteria:
* Women ≥18yrs presenting to UAB urogynecology and continence clinics with co-occurring UUI and FI
* Willing to complete all study related items
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03543566
Study Brief:
Protocol Section:
NCT03543566