Enema Device for Children With Spina Bifida
Primary Purpose
Spina Bifida, Fecal Incontinence
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Use of the foley catheter assistive device
Sponsored by
About this trial
This is an interventional supportive care trial for Spina Bifida
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Use of Foley Catheter Assistive Device
Arm Description
All participants will use Foley Catheter Assistive Device
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05253196
First Posted
September 13, 2021
Last Updated
May 8, 2023
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT05253196
Brief Title
Enema Device for Children With Spina Bifida
Official Title
Enema Device for Children With Spina Bifida
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Patients meeting inclusion criteria will be enrolled while they are here on campus for a regular clinic visit. Once they consent, they will complete a baseline survey, and will be given the FCAD with the instruction manual and the investigators will go over how to use the device and answer any questions. The PI will be available throughout the study for any questions that may arise. Participants will use the device for their regular enemas for up to 4 weeks. If the device is negatively impacting enema administration, they can choose to stop using the device at any time but it is preferable that participants use the device five times before they decide it is not working for them. Once a participant has used the device for 4 weeks or has chosen to opt out of completing the 4-week trial, they will complete a second survey. The baseline survey will assess how current enema administration practices are going and the second survey will assess how well enema administration is going while using the device. If time allows and user feedback indicates a need, the device will be modified, and participants asked to use the second version for up to 4 weeks. Again, if the device is negatively impacting enema administration, they can choose to stop using the second version of the device at any time but it's preferable that participants use it five times before deciding it is not working for them. Once a participant has used the second version of the device for 4 weeks, or chosen to opt out of completing the 4-week trial, they will complete a third survey assessing the second version of the device. If traveling to CHCO is not convenient, the second version of the device will be mailed to the participant and they will complete the surveys via email or over the phone. This eliminates the need for a return trip to CHCO. REDCap will be used for all surveys. If participants are not able to complete the surveys electronically for any reason, they will complete a hardcopy version, or the survey will be administered over the phone, whichever is convenient for the participant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spina Bifida, Fecal Incontinence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Use of Foley Catheter Assistive Device
Arm Type
Experimental
Arm Description
All participants will use Foley Catheter Assistive Device
Intervention Type
Device
Intervention Name(s)
Use of the foley catheter assistive device
Intervention Description
All participants will use the foley catheter assistive device when performing their daily enema
Primary Outcome Measure Information:
Title
Feedback Survey
Description
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.
Time Frame
4 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Ketzer
Phone
720-777-4960
Email
Jill.Ketzer@childrenscolorado.org
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Bischoff, MD
Phone
720-777-9448
Email
andrea.bischoff@childrenscolorado.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Enema Device for Children With Spina Bifida
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