Recruiting

Bowel Management Program

Sponsor:

University of Colorado, Denver

Code:

NCT05253196

Conditions

Spina Bifida

Fecal Incontinence

Eligibility Criteria

Sex: All

Age: 2 - 30

Healthy Volunteers: Not accepted

Interventions

Use of the foley catheter assistive device

Study Details

Brief summary:

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.

Conditions

Spina Bifida

Fecal Incontinence

Study ID

NCT05253196

Start date

Aug 11, 2026

Status verified date

Aug, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 30

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Use of Foley Catheter Assistive Device

All participants will use Foley Catheter Assistive Device

Interventions

Use of the foley catheter assistive device

All participants will use the foley catheter assistive device when performing their daily enema

Primary outcome measure

  • Feedback Survey [ Time Frame: 4 Weeks ]

Central Contacts and Locations

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Andrea Bischoff, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-09-03.