Status:
ACTIVE_NOT_RECRUITING
Incontinence and Quality of Life in Children With Spina Bifida
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Spina Bifida
Myelomeningocele
Eligibility:
All Genders
8+ years
Phase:
NA
Brief Summary
This study aims to develop an innovative, interactive tool for joint use by spina bifida patients and their urologists to identify patients interested in addressing their urinary and fecal incontinenc...
Detailed Description
Phase 1: Stakeholder Group. The investigators will engage 30 dyads of children and adolescents with spina bifida aged 8-17 years old, who experienced any urinary and fecal incontinence in the past 4 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2026
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT03410667
Start Date
December 1 2019
End Date
March 15 2026
Last Update
October 1 2025
Active Locations (1)
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1
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202