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Bowel Continence Across the Lifespan in People With Spina Bifida

Study acronym: BCALS
StatusRecruiting
PhaseNot specified
SponsorDavid Chu
Started
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Record History

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  1. Secondary endpoints: details revised at 4 of 5 entries
    • Site details revised at 18 of 24 sites
    • Eligibility criteria expanded, about 4 words
  2. Recruitment opened
    • Site details revised at 24 of 24 sites
    v3
  3. Secondary endpoints revised (5)v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this observational study is to learn how different enema programs affect bowel control in children and adults with spina bifida. An enema program involves putting liquid into the large intestine (colon) to help someone poop. The main questions it aims to answer are: 1. How well do different enema programs prevent bowel accidents? 2. How do these enema programs affect independence, bowel symptoms, and quality of life? Researchers will compare two types of enema programs to see which works better and is easier for participants to manage. Participants starting a new enema program will answer online survey questions at 3 different timepoints over the course of 1 year.
Trial Details
NCT Number NCT07390318
Lead Sponsor David Chu
Collaborators: Patient-Centered Outcomes Research Institute
Conditions
(from sponsor)		 Spina Bifida, Neurogenic Bowel, Bowel Incontinence
Related terms Fecal Incontinence, Neurogenic Bowel, Spinal Dysraphism
Enrollment 943 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov