An observational study in Spina Bifida, Neurogenic Bowel and Bowel Incontinence, sponsored by David Chu. Recruiting at 24 sites in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by David Chu · Observational
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:
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.
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.
142 studies on the registry are indexed under Spinal Dysraphism; 39 are open to participants now.
This study's planned enrollment of 943 is above the median of 105 across 48 observational studies indexed under Spinal Dysraphism.
Browse Spinal Dysraphism studies →This is the only study on the registry with David Chu as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Other types of spinal dysraphism (e.g., lipomyelomeningocele, fatty filum)
Participants starting a retrograde enema program, as part of standard care prescribed by their local clinical team.
Procedure: Retrograde Enema
Participants starting an antegrade enema program, as part of standard care prescribed by their local clinical team.
Procedure: Antegrade 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).
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.
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)
Time frame: Before starting enema program, 6 months after starting enema program, 1 year after starting enema program
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: For 1 year after starting enema program
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