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.

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.