Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a randomized, controlled study. This study will be performed at Aarhus University Hospital (Denmark) and Aalborg University Hospital (Denmark) following the same protocol. According to the initial randomization, children will be allocated to treatment with the new system (group A) or with the currently used system (group B). After a period of 6 weeks the child will crossover to use the contrary system. The hypothesis is that A TAI system specifically developed for children will enhance the child's toleration of irrigation due to fewer reports on pain at insertion which will lead to better compliance. This outcome will induce a comparable or better effect on their fecal incontinence and reduce the needed follow-up period due to fewer incontinence relapse.

Official Title
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Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence

Conditions
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Fecal Incontinence, Constipation - Functional

Intervention / Treatment
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* Device: Cone Small, Qufora A/S
* Device: Colotip, Coloplast A/S


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The children will use either the old or the new cone for transanal irrigation for 6 weeks and then crossover to the contrary cone.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Newly developed cone for 6 weeks the currently used cone for 6 weeks<br>Starts off with treatment with the newly developed cone for transanal irrigation for 6 weeks and are then instructed to crossover to the contrary system, the currently used, for additional 6 weeks. | Device: Cone Small, Qufora A/S<br>* Newly developed cone in a softer material and a design matching the use for transanal irrigation.<br>Device: Colotip, Coloplast A/S<br>* Cone currently used for transanal irrigation at the Pediatric Ward, Aarhus University Hospital.<br>|
| Active Comparator: Currently used cone for 6 weeks the newly developed cone for 6 weeks<br>Starts off with treatment with the currently used cone for transanal irrigation for 6 weeks and are then instructed to crossover to the contrary system, the currently used, for additional 6 weeks. | Device: Cone Small, Qufora A/S<br>* Newly developed cone in a softer material and a design matching the use for transanal irrigation.<br>Device: Colotip, Coloplast A/S<br>* Cone currently used for transanal irrigation at the Pediatric Ward, Aarhus University Hospital.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect on fecal incontinence episode frequency | Evaluated by home recordings. | 12 weeks | 
| Evaluation of discomfort and on pain assessed on a Visual Analog Scale | Evaluated by home recordings. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of constipation | Evaluated by home recordings and transabdominal rectal ultra sound. | 12 weeks | 
| Evaluation of urinary incontinence episodes | Evaluated by home recordings. | 12 weeks | 
| Evaluation of compliance assessment using the different systems | Evaluated by home recordings. | 12 weeks | 
| Estimation in changes of the child's well-being | Evaluated by home recordings using WHO-5 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transanal irrigation