Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence
- Conditions
- Constipation - FunctionalFecal Incontinence
- Interventions
- Device: Cone Small, Qufora A/SDevice: Colotip, Coloplast A/S
- Registration Number
- NCT05032534
- Lead Sponsor
- University of Aarhus
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- Fecal incontinence on neurogenic or non-neurogenic basis, where transanal irrigation is indicated.
- Morbus Hirschsprungs disease.
- Anorectal malformations.
- Use of medication that are known to cause constipation (e.g. anticholinergics)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Newly developed cone for 6 weeks the currently used cone for 6 weeks Cone Small, Qufora A/S 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. Newly developed cone for 6 weeks the currently used cone for 6 weeks Colotip, Coloplast A/S 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. Currently used cone for 6 weeks the newly developed cone for 6 weeks Cone Small, Qufora A/S 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. Currently used cone for 6 weeks the newly developed cone for 6 weeks Colotip, Coloplast A/S 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.
- Primary Outcome Measures
Name Time Method The effect on fecal incontinence episode frequency 12 weeks Evaluated by home recordings.
Evaluation of discomfort and on pain assessed on a Visual Analog Scale 12 weeks Evaluated by home recordings.
- Secondary Outcome Measures
Name Time Method Extent of constipation 12 weeks Evaluated by home recordings and transabdominal rectal ultra sound.
Evaluation of urinary incontinence episodes 12 weeks Evaluated by home recordings.
Evaluation of compliance assessment using the different systems 12 weeks Evaluated by home recordings.
Estimation in changes of the child's well-being 12 weeks Evaluated by home recordings using WHO-5
Trial Locations
- Locations (2)
Aarhus University Hospital
🇩🇰Aarhus, Central Denmark Region, Denmark
Aalborg University Hospital
🇩🇰Aalborg, The North Denmark Region, Denmark