Fecal Incontinence Clinical Trial
Official title:
Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence
Verified date | August 2021 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to investigate if a new irrigation system for transanal irrigation (TAI) is effective and more tolerable than the currently used system at the Pediatric Ward at Aarhus University Hospital.
Status | Completed |
Enrollment | 14 |
Est. completion date | July 31, 2022 |
Est. primary completion date | July 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 17 Years |
Eligibility | Inclusion Criteria: - Fecal incontinence on neurogenic or non-neurogenic basis, where transanal irrigation is indicated. Exclusion Criteria: - Morbus Hirschsprungs disease. - Anorectal malformations. - Use of medication that are known to cause constipation (e.g. anticholinergics) |
Country | Name | City | State |
---|---|---|---|
Denmark | Aalborg University Hospital | Aalborg | The North Denmark Region |
Denmark | Aarhus University Hospital | Aarhus | Central Denmark Region |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aalborg University Hospital, Aarhus University Hospital, Qufora A/S |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The effect on fecal incontinence episode frequency | Evaluated by home recordings. | 12 weeks | |
Primary | Evaluation of discomfort and on pain assessed on a Visual Analog Scale | Evaluated by home recordings. | 12 weeks | |
Secondary | Extent of constipation | Evaluated by home recordings and transabdominal rectal ultra sound. | 12 weeks | |
Secondary | Evaluation of urinary incontinence episodes | Evaluated by home recordings. | 12 weeks | |
Secondary | Evaluation of compliance assessment using the different systems | Evaluated by home recordings. | 12 weeks | |
Secondary | Estimation in changes of the child's well-being | Evaluated by home recordings using WHO-5 | 12 weeks |
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