Recruiting

Enema ProgramsBowel Continence Across the Lifespan in People With Spina Bifida

Sponsor:

David Chu

Code:

NCT07390318

Conditions

Spina Bifida

Neurogenic Bowel

Bowel Incontinence

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Not accepted

Interventions

Retrograde Enema

Antegrade Enema

Study Details

Brief 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.

Conditions

Spina Bifida

Neurogenic Bowel

Bowel Incontinence

Study ID

NCT07390318

Start date

Apr 1, 2026

Status verified date

Jan, 2026

Completion date

May 1, 2030

Anticipated

Primary completion date

May 1, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

\- Other types of spinal dysraphism (e.g., lipomyelomeningocele, fatty filum)

Study Design

Enrollment

943 participants

Anticipated

Interventions and Outcome Measures

Arms

Retrograde Enema

Participants starting a retrograde enema program, as part of standard care prescribed by their local clinical team.

Antegrade Enema

Participants starting an antegrade enema program, as part of standard care prescribed by their local clinical team.

Interventions

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).

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.

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 and Locations

Central contacts

Josephine Hirsch

312-227-6076 jahirsch@luriechildrens.org

Ilina Rosoklija

312-227-6409 irosoklija@luriechildrens.org

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

Destiny Taylor

205-224-2567 destinytaylor@uabmc.edu

Children's of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Samuel Dransfield

205-641-6620 sdransfield@uabmc.edu

Phoenix Children's Hospital

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Erica Weidler

602-933-3524 ebaimbridge@phoenixchildrens.org

Children's Hospital of Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Kristy Azpilicueta

323-361-7079 kazpilicueta@chla.usc.edu

University of California San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Nicole Greco

415-347-5850 Nicole.Greco@ucsf.edu

Children's Hospital of Colorado

Recruiting

Denver, Colorado, United States, 80218

Contacts

Rose Prieto

720.777.2727 TeamPure@cuanschutz.edu

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

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Danielle Herrera

312-227-6429 daherrera@luriechildrens.org

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Danielle Herrera

312-227-6429 daherrera@luriechildrens.org

Riley Children's Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Jeremy Koehlinger

317-274-1615 peduro@iu.edu

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Giovanna Stefanini

617-355-4009 Giovanna.Stefanini@childrens.harvard.edu

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Andrea Pires

919-660-8218 andrea.pires@duke.edu

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Chase Wullenweber

513-284-4399 chase.wullenweber@cchmc.org

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Madison Lapid

614-355-4526 Madison.Lapid@nationwidechildrens.org

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19139

Contacts

Amelia Wildermuth

wildermuta@chop.edu

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Sara Izzo

412-642-5494 sai20@pitt.edu

Monroe Carell Jr. Children's Hospital at Vanderbilt

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Douglass Clayton

615-936-1060 Douglas.B.Clayton@vumc.org

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Jessica Kamen

832-826-2387 jessica.kamen@bcm.edu

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Shing Varakitsomboon

206-987-0042 shing.varakitsomboon@seattlechildrens.org

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Judith Hagedorn

206-744-4711 judithch@uw.edu

More Information

Sponsor

David Chu

Last update posted

Apr 21, 2026

Last verified

Jan, 2026

Keywords

retrograde enema
antegrade enema
bowel management program
bowel continence program
self-management
quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by David Chu on 2026-04-21.