Enema Device for Children With Spina Bifida

Launched by UNIVERSITY OF COLORADO, DENVER · Feb 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new enema device designed to help children with spina bifida who experience fecal incontinence, which means they have difficulty controlling their bowel movements. The trial aims to improve the way enemas are administered, making it easier and more effective for these children to manage their bowel health. Currently, many of these kids use a special program to stay clean, but those with spina bifida often have more challenges due to weaker muscle control around the anus. This study seeks to create a better tool to help them have fewer accidents and feel more confident.

To be eligible for this trial, participants should be between 2 and 30 years old, have poor muscle tone in the anal area, and regularly use enemas as part of their bowel management. Unfortunately, non-English speakers, pregnant women, and certain other individuals cannot participate. If eligible, participants can expect to help test this new device, which could lead to better bowel management options for kids with spina bifida and improve their quality of life.

Gender

ALL

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