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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
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spina Bifida

Eligibility Criteria

2 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 13, 2021
    Last Updated
    May 8, 2023
    Sponsor
    University of Colorado, Denver
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    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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