Bowel continence across life for people with spina bifida
Comparing Antegrade Versus Retrograde Enemas To Improve Bowel Continence Across the Lifespan in People With Spina Bifida
This project will test whether retrograde (through the anus) or antegrade (through a tube into the colon) enema programs work better to prevent bowel accidents and improve independence for people with spina bifida ages 5 and up who are starting or switching an enema program.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 943 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago Academic / other |
| Locations | 24 sites (Birmingham, Alabama and 23 other locations) |
| Trial ID | NCT07390318 on ClinicalTrials.gov |
What this trial studies
This is a multi-center observational study enrolling children and adults with myelomeningocele-type spina bifida who are starting or switching between retrograde and antegrade enema programs. Participants will complete online surveys in English or Spanish at three timepoints over one year to report bowel accidents, bowel symptoms, independence with bowel care, and quality of life. Researchers will compare outcomes between the two enema approaches to identify differences in effectiveness and ease of self-management. The study plans to enroll a large cohort across multiple U.S. sites to reflect real-world patient experiences.
Who should consider this trial
Good fit: People aged 5 years and older with myelomeningocele spina bifida who are English- or Spanish-literate and who are starting or switching to a retrograde or antegrade enema program are ideal candidates.
Not a fit: People with other forms of spinal dysraphism (for example, lipomyelomeningocele or fatty filum), those not starting or changing an enema program, or those who cannot complete online surveys in English or Spanish are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could give patients and clinicians clearer, evidence-based guidance on which enema approach is more likely to reduce bowel accidents and improve independence.
How similar studies have performed: Both enema approaches are used in clinical practice, but large comparative studies are limited, so direct evidence showing one approach is superior is currently lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Minimum age 5 years old * Myelomeningocele diagnosis * Starting a retrograde or antegrade enema program (or switching from one enema program to the other) * English or Spanish speaking/literate Exclusion Criteria: \- Other types of spinal dysraphism (e.g., lipomyelomeningocele, fatty filum)
Where this trial is running
Birmingham, Alabama and 23 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Children's of Alabama — Birmingham, Alabama, United States (Recruiting)
- Phoenix Children's Hospital — Phoenix, Arizona, United States (Recruiting)
- Children's Hospital of Los Angeles — Los Angeles, California, United States (Recruiting)
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- Children's Hospital of Colorado — Denver, Colorado, United States (Recruiting)
- Children's National Hospital — Washington D.C., District of Columbia, United States (Not_yet_recruiting)
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Riley Children's Hospital — Indianapolis, Indiana, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Not_yet_recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Not_yet_recruiting)
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States (Recruiting)
- Scottish Rite for Children — Dallas, Texas, United States (Not_yet_recruiting)
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
- Primary Children's Hospital — Salt Lake City, Utah, United States (Not_yet_recruiting)
- Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Josephine Hirsch
- Email: jahirsch@luriechildrens.org
- Phone: 312-227-6076
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.