Constipation - Functional, Fecal Incontinence
Conditions
Keywords
Transanal irrigation
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.
Interventions
DEVICECone Small, Qufora A/S
Newly developed cone in a softer material and a design matching the use for transanal irrigation.
DEVICEColotip, Coloplast A/S
Cone currently used for transanal irrigation at the Pediatric Ward, Aarhus University Hospital.
Sponsors
Aarhus University Hospital
Aalborg University Hospital
Qufora A/S
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Denmark
Outcome results
None listed