Enema Device for Children With Spina Bifida

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates the use of a Foley catheter assistive device for daily enema administration in pediatric to young adult patients with spina bifida and fecal incontinence. Participants will use the device for up to 4 weeks, complete baseline and follow-up surveys, and may try a modified version if feedback indicates need. The study aims to determine feasibility, user experience, and potential improvements in colon cleanliness and routine adherence. Enrollment occurs during routine clinic visits at Children’s Hospital Colorado under the University of Colorado, Denver. The lead sponsor is the University of Colorado, Denver, with site participation at Children’s Hospital Colorado in Aurora, CO.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Poor sphincter tone
* Perform regular enemas for bowel management (due to fecal incontinence)
* 2 - 30 years old

Exclusion Criteria:

* Non English speakers
* Prisoners
* Pregnant women
* Wards of state
* Decisionally challenged adults

Where it's running

• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting

Study contacts

• Study coordinator: Jill Ketzer
• Email: Jill.Ketzer@childrenscolorado.org
• Phone: 720-777-4960

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.