Bowel Continence Across the Lifespan in People with Spina Bifida
Investigating Enema Programs in Individuals with Spina Bifida
Konrad Szymanski, MD
Primary Investigator
Brief description of study
The purpose of this study is to compare these two types of enema programs in children and adults with spina bifida across the United States. We want to learn about how well enemas work to prevent bowel accidents and other bowel problems, how well people can do their enemas on their own, how often people have enema problems, and the quality of life of people who use enemas.
Detailed description of study
Aim 1: Compare the primary outcome of bowel continence in
children and adults with spina bifida who start retrograde versus
antegrade enemas.
Aim 2: Assess stakeholder perspectives on bowel incontinence
and barriers and facilitators to bowel management strategies by
conducting qualitative semi-structed key informant interviews in
children and adults with spina bifida and caregivers of children
and adults with spina bifida.
Secondary Objective(s) Aim 1: The secondary objectives are to compare bowel symptoms, quality
of life, self-management and independence, and unplanned healthcare
utilization in children and adults with spina bifida who start retrograde
versus antegrade enemas.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Myelomeningocele, MM, Spina Bifida, Bowel Continence, Riley
-
Age: 5 years - 100 years
-
Gender: All
Inclusion Criteria
• Minimum age 5 years old
• MM 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)
Aim 2:
Inclusion Criteria
• Patient participants
o Minimum age 12 years old
o MM diagnosis
o Undergone discussion at any time with the local clinical team to initiate a
retrograde or antegrade enema program (or switch from one enema
program to the other), even if they do not ultimately proceed with an
enema program
o English speaking
• Caregiver/parent participants
o Caregiver or parent of children of any age or an adult with MM who has
undergone discussion at any time with the local clinical team to initiate a
retrograde or antegrade enema program (or switch from one enema
program to the other), even if they do not ultimately proceed with an
enema program
o English speaking
Exclusion Criteria
• Significant cognitive impairment determined by the local clinical teams, leading to
inability to participate in the interview
• Other types of spinal dysraphism (e.g., lipomyelomeningocele, fatty filum)
This study investigates bowel continence in people with spina bifida, a condition where the spine and spinal cord don't form properly. The purpose of this study is to compare two types of enema programs in children and adults with spina bifida across the United States. Researchers want to learn how well these enemas work to prevent bowel accidents and other bowel problems, how well people can do their enemas on their own, and the quality of life of people who use enemas.
Participants will be involved in different study arms starting either retrograde or antegrade enemas. The study will also include interviews with participants and their caregivers to understand their perspectives on bowel management and any barriers they face. Secondary objectives include comparing bowel symptoms, quality of life, self-management, and healthcare use in the different study arms.
- Who can participate: Children aged 5 and older and adults with a diagnosis of myelomeningocele (MM) are eligible if they are starting or switching enema programs. Participants must speak English or Spanish. Those with other types of spinal dysraphism are excluded.
- Study details: Participants will start either a retrograde or antegrade enema program. Interviews will be conducted to gather insights from participants and their caregivers about their experiences with bowel management strategies.
