Health TrialsbyHealthPanel

Bowel Continence Across the Lifespan in People With Spina Bifida

ConditionsSpina BifidaNeurogenic BowelBowel Incontinence
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5+
SponsorDavid Chu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Retrograde Enema

    Procedure/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 Enema

    Procedure/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.

Treatment groups

943 Participants
are divided into 2 treatment groups
Group A: Retrograde Enema1 intervention
Group B: Antegrade Enema1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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.
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

David Chu

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Sponsor institution

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov
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