Home › Spina Bifida › NCT05253196
Enema Device for Children With Spina Bifida
Who can join
Ages 2 to 30 · All sexes
Full eligibility criteria
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
About the study
The International Center for Colorectal and Urogenital Care at Children's Hospital Colorado treats patients who suffer from many different colorectal issues such as anorectal malformation, Hirschsprung disease, and severe constipation. Many of these patients suffer from fecal incontinence. The investigators have developed a week long bowel management program (BMP) that is offered every month to help these kids stay clean of stool in the underwear, by finding the perfect enema recipe to clean the colon for 24 hours. This allows one to perform an enema once every day, clean their colon, and remain free of 'accidents'. Many spina bifida patients also suffer from fecal incontinence and are referred to this BMP. The overall success rate for all patients who suffer from fecal incontinence is 95%, however the success rate for spina bifida patients is only 77%. The reason for this decrease in success is due to the lack of anal sphincter tone in spina bifida patients, which leads to inadvertent leakage and spillage of enema fluid and bowel content during enema administration. The purpose of this study is to create and test an enema administration device that improves upon current methods.
What is being tested
- Use of the foley catheter assistive device (device)
Sponsor: University of Colorado, Denver · Participants: 20 · Started: Aug 11, 2026
Contact the study team
- Jill Ketzer · Phone: 720-777-4960
- Andrea Bischoff, MD · Phone: 720-777-9448
Official record on ClinicalTrials.gov — NCT05253196
Locations in the U.S.
| Colorado | Children's Hospital Colorado, Aurora |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.