Hirschsprung Disease Clinical Trials

Find Hirschsprung Disease Clinical Trials Near You

Enema Device for Children With Spina Bifida

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 30
Healthy Volunteers: f
View:

• Poor sphincter tone

• Perform regular enemas for bowel management (due to fecal incontinence)

• 2 - 30 years old

Locations
United States
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Contact Information
Primary
Jill Ketzer
Jill.Ketzer@childrenscolorado.org
720-777-4960
Backup
Andrea Bischoff, MD
andrea.bischoff@childrenscolorado.org
720-777-9448
Time Frame
Start Date: 2026-08-11
Estimated Completion Date: 2028-08
Participants
Target number of participants: 20
Treatments
Experimental: Use of Foley Catheter Assistive Device
All participants will use Foley Catheter Assistive Device
Sponsors
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov