Spina BifidaBCALSNCT07390318
Bowel Continence Across the Lifespan in People With Spina Bifida
An observational study of Spina Bifida and Neurogenic Bowel, run by David Chu at 24 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Spina Bifida, Neurogenic Bowel, Bowel Incontinence
- What is being tested?
- Retrograde Enema and Antegrade Enema
- Type of treatment
- Surgery or procedure
- How many people
- 943 participants
- Where
- 24 sitesUnited States
- Study dates
- 1 Apr 2026to 1 May 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Other types of spinal dysraphism (e.g., lipomyelomeningocele, fatty filum)
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
United States24 sites, 24 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Rebecca Parten, 734-763-4645, rparten@med.umich.edu
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35205
Destiny Taylor, 205-224-2567, destinytaylor@uabmc.edu
- Recruiting
Children's of Alabama
Birmingham, Alabama, 35233
Destiny Taylor, 205-224-2567, destinytaylor@uabmc.edu
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Giovanna Stefanini, 617-355-4009, Giovanna.Stefanini@childrens.harvard.edu
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Danielle Herrera, 312-227-6429, daherrera@luriechildrens.org
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Danielle Herrera, 312-227-6429, daherrera@luriechildrens.org
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Chase Wullenweber, 513-284-4399, chase.wullenweber@cchmc.org
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Sarah Wido, 216-444-2266, widos@ccf.org
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Swapna Koppera, 614-722-3363, Swapna.Koppera@nationwidechildrens.org
- Recruiting
Scottish Rite for Children
Dallas, Texas, 75219
Daralyn Fulton, 214-559-7408, daralyn.fulton@tsrh.org
- Recruiting
Children's Hospital of Colorado
Denver, Colorado, 80218
Rose Prieto, 720.777.2727, TeamPure@cuanschutz.edu
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27705
Andrea Pires, 919-660-8218, andrea.pires@duke.edu
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Jessica Kamen, 832-826-2387, jessica.kamen@bcm.edu
- Recruiting
Riley Children's Hospital
Indianapolis, Indiana, 46202
Jeremy Koehlinger, 317-274-1615, peduro@iu.edu
- Recruiting
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Kristy Azpilicueta, 323-361-7079, kazpilicueta@chla.usc.edu
- Recruiting
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Douglass Clayton, 615-936-1060, Douglas.B.Clayton@vumc.org
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19139
Amelia Wildermuth, wildermuta@chop.edu
- Recruiting
Phoenix Children's Hospital
Phoenix, Arizona, 85006
Erica Weidler, 602-933-3524, ebaimbridge@phoenixchildrens.org
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224
Sara Izzo, 412-642-5494, sai20@pitt.edu
- Not yet recruiting
Primary Children's Hospital
Salt Lake City, Utah, 84113
Elizabeth Lignell, 801-213-2718, Elizabeth.Lignell@hsc.utah.edu
- Recruiting
University of California San Francisco
San Francisco, California, 94158
Nicole Greco, 415-347-5850, Nicole.Greco@ucsf.edu
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Shing Varakitsomboon, 206-987-0042, shing.varakitsomboon@seattlechildrens.org
- Recruiting
University of Washington
Seattle, Washington, 98195
Judith Hagedorn, 206-744-4711, judithch@uw.edu
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Bruce Sprague, 202-476-3433, bsprague@childrensnational.org
About this study
Official title: 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:
- How well do different enema programs prevent bowel accidents?
- 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.
Read the 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.
- Conditions
- Spina Bifida, Neurogenic Bowel, Bowel Incontinence
- Being tested
- Retrograde Enema, Antegrade Enema
- Keywords
- retrograde enema, antegrade enema, bowel management program, bowel continence program, self-management, quality of life
- Medical subject headings
- Spinal Dysraphism, Neurogenic Bowel, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde EnemaProcedure or surgery
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 EnemaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Retrograde Enema | Participants starting a retrograde enema program, as part of standard care prescribed by their local clinical team. Receives: Procedure: Retrograde Enema | |
| Antegrade Enema | Participants starting an antegrade enema program, as part of standard care prescribed by their local clinical team. Receives: Procedure: Antegrade Enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Before starting enema program, 6 months after starting enema program, 1 year after starting enema program
Secondary outcomes (5)
Bowel symptoms and satisfaction
Measured using the Neurogenic Bowel Dysfunction (NBD) score. Scores range from 0-47, higher scores mean greater severity of bowel dysfunction.
Measured: Before starting enema program, 6 months after starting enema program, 1 year after starting enema program
Disease-specific quality of life
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.
Measured: Before starting enema program, 6 months after starting enema program, 1 year after starting enema program
Overall quality of life
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.
Measured: Before starting enema program, 6 months after starting enema program, 1 year after starting enema program.
Self-management and independence
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.
Measured: 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
Number of emergency room visits, urgent care or immediate care visits, and urgent outpatient ambulatory visits related to bowel issues.
Measured: For 1 year after starting enema program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Apr 2026
- Primary completion1 May 2030 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 943 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Chu
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor-investigator, David Chu, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390318
- Sponsor's protocol ID
- STUDY00000320
- Acronym
- BCALS
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No