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NOT YET RECRUITING
NCT07390318

Bowel Continence Across the Lifespan in People With Spina Bifida

Sponsor: David Chu

View on ClinicalTrials.gov

Summary

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.

Official title: Comparing Antegrade Versus Retrograde Enemas To Improve Bowel Continence Across the Lifespan in People With Spina Bifida

Key Details

Gender

All

Age Range

5 Years - Any

Study Type

OBSERVATIONAL

Enrollment

943

Start Date

2026-04-01

Completion Date

2030-05-01

Last Updated

2026-02-06

Healthy Volunteers

No

Interventions

PROCEDURE

Retrograde 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).

PROCEDURE

Antegrade Enema

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.

Locations (24)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Children's of Alabama

Birmingham, Alabama, United States

Phoenix Children's Hospital

Phoenix, Arizona, United States

Children's Hospital of Los Angeles

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

Children's Hospital of Colorado

Denver, Colorado, United States

Children's National Hospital

Washington D.C., District of Columbia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Northwestern University

Chicago, Illinois, United States

Riley Children's Hospital

Indianapolis, Indiana, United States

Boston Children's Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Duke University Medical Center

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Scottish Rite for Children

Frisco, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

Seattle Children's Hospital

Seattle, Washington, United States

University of Washington

Seattle, Washington, United States