Bowel Continence Across the Lifespan in People With Spina Bifida
BCALS
Comparing Antegrade Versus Retrograde Enemas To Improve Bowel Continence Across the Lifespan in People With Spina Bifida
1 other identifier
observational
943
1 country
24
Brief Summary
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2026
Longer than P75 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2026
CompletedFirst Posted
Study publicly available on registry
February 5, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
April 21, 2026
January 1, 2026
4.1 years
January 28, 2026
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bowel continence
Measured with a single question on bowel incontinence frequency in the past month, with "continence" strictly defined as answering "never": (Daily, Weekly, Monthly, Never)
Before starting enema program, 6 months after starting enema program, 1 year after starting enema program
Secondary Outcomes (5)
Bowel symptoms and satisfaction
Before starting enema program, 6 months after starting enema program, 1 year after starting enema program
Disease-specific quality of life
Before starting enema program, 6 months after starting enema program, 1 year after starting enema program
Overall quality of life
Before starting enema program, 6 months after starting enema program, 1 year after starting enema program.
Self-management and independence
Before starting enema program, 6 months after starting enema program, 1 year after starting enema program
Rate of unplanned healthcare utilization related to bowel issues
For 1 year after starting enema program
Study Arms (2)
Retrograde Enema
Participants starting a retrograde enema program, as part of standard care prescribed by their local clinical team.
Antegrade Enema
Participants starting an antegrade enema program, as part of standard care prescribed by their local clinical team.
Interventions
A retrograde enema is a bowel management technique in which the enema is given through the rectum (end of the colon). This includes cone enemas, foley balloon enemas, and Transanal irrigation (e.g. Peristeen, Navina).
An antegrade enema is a bowel management technique in which an enema is given through a surgically-created tube that enters at the start of the colon. This includes MACES, cecostomy buttons, and Chait tubes.
Eligibility Criteria
Children, adolescents, and adults age 5 years and older with spina bifida starting a new enema program at one of 24 participating clinical centers in the United States.
You may qualify if:
- 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
You may not qualify if:
- \- Other types of spinal dysraphism (e.g., lipomyelomeningocele, fatty filum)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- David Chulead
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (24)
University of Alabama at Birmingham
Birmingham, Alabama, 35205, United States
Children's of Alabama
Birmingham, Alabama, 35233, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85006, United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of California San Francisco
San Francisco, California, 94158, United States
Children's Hospital of Colorado
Denver, Colorado, 80218, United States
Children's National Hospital
Washington D.C., District of Columbia, 20010, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Northwestern University
Chicago, Illinois, 60611, United States
Riley Children's Hospital
Indianapolis, Indiana, 46202, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19139, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232, United States
Scottish Rite for Children
Dallas, Texas, 75219, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
University of Washington
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator; Attending Physician, Urology; Associate Professor of Urology at Northwestern University Feinberg School of Medicine
Study Record Dates
First Submitted
January 28, 2026
First Posted
February 5, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
May 1, 2030
Study Completion (Estimated)
May 1, 2030
Last Updated
April 21, 2026
Record last verified: 2026-01