20 Participants NeededMy employer runs this trial

Enema Device for Spina Bifida

JK
AB
Overseen ByAndrea Bischoff, MD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for children and young adults aged 2 to 30 years old with spina bifida who have poor anal sphincter tone and need regular enemas to manage fecal incontinence.

Inclusion Criteria

I have weak muscle control in my anal area.
I am between 2 and 30 years old.
I use regular enemas to manage bowel incontinence.

Exclusion Criteria

Non English speakers
I have difficulty making my own medical decisions.
Wards of state
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • Use of the foley catheter assistive device

Trial Overview

The study is testing a new enema device (using a Foley catheter) designed to help prevent leakage during enemas, aiming to improve bowel management for kids with spina bifida.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Use of Foley Catheter Assistive DeviceExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+