Bowel continence across life for people with spina bifida
Official title: Comparing Antegrade Versus Retrograde Enemas To Improve Bowel Continence Across the Lifespan in People With Spina Bifida
Run by Ann & Robert H Lurie Children's Hospital of Chicago · NCT07390318 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 5 Years and up |
| Sex | All |
| Enrollment | 943 (estimated) |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago Academic / other |
| Locations | 24 sites (Birmingham, Alabama and 23 other locations) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | May 1, 2030 |
| Study ends | May 1, 2030 |
| Registry record updated | September 24, 2026 |
| Trial ID | NCT07390318 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Show 18 more locations
-
Children's National Hospital
Washington D.C., District of Columbia, United States 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 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 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 Recruiting -
Texas Children's Hospital
Houston, Texas, United States Recruiting -
Seattle Children's Hospital
Seattle, Washington, United States Recruiting -
University of Washington
Seattle, Washington, United States Recruiting -
Primary Children's Hospital
Salt Lake City, Utah, United States Not yet recruiting
Study contacts
- Study coordinator: Josephine Hirsch
- Email: jahirsch@luriechildrens.org
- Phone: 312-227-6076
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Time comparison of bowel programs in spinal cord injury
This study tests which of three bowel-management tools (a suppository, a mini enema, or a transanal irrigation device) helps people with spinal cord injury complete their bowel program the quickest.
-
Able Kids device: safer gait aid for kids with neurologic gait problems
This study tests whether the ABLE Kids wearable exoskeleton can be safely used during a 10-session gait training program for children with neurological gait disorders or muscle weakness.
-
tSCS for improving leg strength and walking in kids with spina bifida
This pilot test will try non-invasive transcutaneous spinal cord stimulation to see if it helps improve leg muscle strength and walking in children with myelomeningocele who can walk a little with help.
-
Pediatric Manual Mobile Standing Wheelchair: Preliminary Utility
This study tests a new manual standing wheelchair for children aged 8-17 who use a manual chair and participate in standing programs to see if the device is practical and helpful.
-
Unstimulated gluteus maximus sphincteroplasty to treat bowel incontinence
This procedure tests whether using the patient's unstimulated gluteus maximus muscle to create a new anal sphincter can help people with severe fecal incontinence that hasn't improved with other treatments.
-
Psychosocial teleassistance programme for adults with spina bifida
This study tests a 10-week group telecare psychological program to see if it improves self-esteem, social skills, and overall psychological well-being in adults with spina bifida.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.