Enema Device for Children With Spina Bifida

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-30
SponsorUniversity of Colorado, Denver

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Poor sphincter tone

Perform regular enemas for bowel management (due to fecal incontinence)

2 - 30 years old

Disqualifiers

Non English speakers

Prisoners

Pregnant women

Wards of state

Trial design

Design model

Single group

Treatments tested in this trial

  • Use of the foley catheter assistive device

    Device

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Use of Foley Catheter Assistive DeviceExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
4 Weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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