Enema Device for Children With Spina Bifida

NCT05253196 | Not Yet Recruiting

• 1 other identifier: 21-2976
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Feedback Survey

  All participants will complete a feedback survey at baseline to assess satisfaction with current enema administration and again after using the device to determine if the device improves enema administration process. Each question from baseline will be compared to the same question after use of device to determine if the response is more positive with device use.

  4 Weeks

Study Arms (1)

Use of Foley Catheter Assistive Device

EXPERIMENTAL

All participants will use Foley Catheter Assistive Device

Device: Use of the foley catheter assistive device

Interventions

Use of the foley catheter assistive device DEVICE

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

Use of Foley Catheter Assistive Device

Eligibility Criteria

• Age: 2 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Poor sphincter tone
• Perform regular enemas for bowel management (due to fecal incontinence)
• years old

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

MeSH Terms

Conditions

Spinal Dysraphism; Fecal Incontinence

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Jill Ketzer

CONTACT

720-777-4960; Jill.Ketzer@childrenscolorado.org

Andrea Bischoff, MD

CONTACT

720-777-9448; andrea.bischoff@childrenscolorado.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: February 23, 2022
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share