Bowel Continence Across the Lifespan in People With Spina Bifida

Conditions

• Bowel Incontinence
• Neurogenic Bowel
• Spina Bifida

Eligibility Criteria

Sex

ALL

Age

5 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Retrograde Enema — PROCEDURE
  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
  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 Details

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.

Key Dates

Start date

Apr 1, 2026

Status verified

Jan 2026

Primary completion

May 1, 2030

Completion

May 1, 2030

Study Design

Enrollment

943 participants (estimated)

Arms

• Arm: Retrograde Enema
  Participants starting a retrograde enema program, as part of standard care prescribed by their local clinical team.
• Arm: Antegrade Enema
  Participants starting an antegrade enema program, as part of standard care prescribed by their local clinical team.

Primary Outcome Measure

Bowel continence [ Time Frame: Before starting enema program, 6 months after starting enema program, 1 year after starting enema program ]

Central Contacts

• Josephine Hirsch
  312-227-6076
  [email protected]
• Ilina Rosoklija
  312-227-6409
  [email protected]

Locations (24)

Find similar trials in Birmingham, AL

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