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:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT03410667
Eligibility Criteria:
Inclusion Criteria:
* Spina bifida
* 8-17 years old
* Followed at Riley Hospital Pediatric Urology Outpatient Clinic
* Primary caregiver is patient's legal guardian
* Urinary incontinence in the past 4 weeks
* Fecal incontinence in the past 4 weeks
* Normal to mildly impaired cognitive development
* English language literacy
* Intent to receive care at the Riley Pediatric Urology Clinic for th extent of the study
The physician panel will be composed of pediatric urologists.
Exclusion Criteria:
* Children with significant cognitive impairment, as they will not be able to express their urinary and fecal incontinence goals.
* Patients who underwent a genitourinary procedure or a bowel procedure in the past 4 weeks, since these patients are often temporarily catheterized and therefore not experiencing their typical level of urinary and fecal incontinence.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Study:
NCT03410667
Study Brief:
Protocol Section:
NCT03410667