Bowel Continence Across the Lifespan in People With Spina Bifida (BCALS)

April 17, 2026 updated by: David Chu

Comparing Antegrade Versus Retrograde Enemas To Improve Bowel Continence Across the Lifespan in People With Spina Bifida

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Spina bifida is a rare disease affecting an estimated 166,000 people in the United States. Because of the birth defect in the spinal cord, many organ systems do not work properly. Included among these affected organ systems are the bowels or intestines, which can lead to bowel incontinence or bowel accidents. Bowel incontinence is very disruptive to the lives of people with spina bifida by affecting their ability to have romantic relationships, find jobs, and overall enjoy their lives. The spina bifida community has recognized bowel incontinence as a top priority for research.

Typically, reducing bowel incontinence and improving bowel continence occurs in a stepwise fashion. After medications by mouth such as laxatives or stool softeners, 2nd line treatments include enema programs. Two types of enema programs currently exist, those given in either a backward direction (given through the anus or end of the large intestine or colon) or in a forward direction (given through a tube that enters the start of the large intestine or colon). These two types of enema programs have different positives and negatives which have not been compared nor studied well. The lack of evidence on which is the better enema program presents a key decisional dilemma for many people with spina bifida who want to improve their bowel continence.

In the current study, the study team will compare the two types of enema programs in 943 children and adults ages 5 years old and up with spina bifida at 24 centers across the United States. The enema programs will be assigned to and started by the participants as part of usual clinical care from their local clinical team. At 6 months and 12 months over a 1-year study period, the study team will look at how the two types of enema programs compare in bowel continence (how well they work to prevent bowel accidents), quality of life (how much people enjoy their lives), bowel symptoms (how well they work to reduce bowel-related symptoms), self-management and independence (how well people can do these enema programs themselves without help), and healthcare utilization (how often these enema programs cause problems needing medical help). The study team will also ask 20 children with spina bifida, 20 adults with spina bifida, and 20 caregivers of children and adults with spina bifida more detailed interview questions about their lived experiences with managing bowel incontinence and their thoughts on how best to start and maintain a successful enema program. The expected study results will help people with spina bifida not only improve their bowel continence, but also their quality of life.

The study team is working with patient and family partners within the spina bifida community, healthcare providers across numerous disciplines, national advocacy organizations (the Spina Bifida Association), and industry partners who make enema devices to design and conduct this study.

Study Type

Observational

Enrollment (Estimated)

943

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • Children's of Alabama
        • Contact:
    • Arizona
      • Phoenix, Arizona, United States, 85006
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital of Los Angeles
        • Contact:
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California San Francisco
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Children's Hospital of Colorado
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann & Robert H. Lurie Children's Hospital of Chicago
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Children's Hospital
        • Contact:
          • Jeremy Koehlinger
          • Phone Number: 317-274-1615
          • Email: peduro@iu.edu
    • Massachusetts
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Not yet recruiting
        • University of Michigan
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University Medical Center
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Cleveland Clinic
        • Contact:
      • Columbus, Ohio, United States, 43205
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Monroe Carell Jr. Children's Hospital at Vanderbilt
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75219
        • Not yet recruiting
        • Scottish Rite for Children
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84113
    • Washington
      • Seattle, Washington, United States, 98105
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrograde Enema
Participants starting a retrograde enema program, as part of standard care prescribed by their local clinical team.
Procedure: Retrograde Enema
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).
Antegrade Enema
Participants starting an antegrade enema program, as part of standard care prescribed by their local clinical team.
Procedure: Antegrade Enema
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel continence
Time Frame: Before starting enema program, 6 months after starting enema program, 1 year after starting enema program
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel symptoms and satisfaction
Time Frame: Before starting enema program, 6 months after starting enema program, 1 year after starting enema program
Measured using the Neurogenic Bowel Dysfunction (NBD) score. Scores range from 0-47, higher scores mean greater severity of bowel dysfunction.
Before starting enema program, 6 months after starting enema program, 1 year after starting enema program
Disease-specific quality of life
Time Frame: Before starting enema program, 6 months after starting enema program, 1 year after starting enema program
Measured using the Quality of Life Assessment in Spina Bifida (QUALAS) Child, Teenager, and Adult questionnaires. Scores range from 0-100, higher scores mean better quality of life.
Before starting enema program, 6 months after starting enema program, 1 year after starting enema program
Overall quality of life
Time Frame: Before starting enema program, 6 months after starting enema program, 1 year after starting enema program.
Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health and Pediatric Global Health 7 questionnaires. Raw scores are converted into T-scores, which range from 16.2-67.7 for PROMIS Global Health and 16-67.5 for PROMIS Pediatric Global Health 7. Higher scores mean better quality of life.
Before starting enema program, 6 months after starting enema program, 1 year after starting enema program.
Self-management and independence
Time Frame: Before starting enema program, 6 months after starting enema program, 1 year after starting enema program
Measured using the Adolescent/Young Adult Self-Management and Independence Scale (AMIS) II. Scores range from 36-252, higher scores mean higher level of 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
Time Frame: For 1 year after starting enema program
Number of emergency room visits, urgent care or immediate care visits, and urgent outpatient ambulatory visits related to bowel issues.
For 1 year after starting enema program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Chu

Collaborators

Patient-Centered Outcomes Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2026

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2030

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000320

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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