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

University of Aarhus14 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fecal Incontinence Constipation - Functional

Interventions

Cone Small, Qufora A/SDEVICE

Newly developed cone in a softer material and a design matching the use for transanal irrigation.

Colotip, Coloplast A/SDEVICE

Cone currently used for transanal irrigation at the Pediatric Ward, Aarhus University Hospital.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 17 Years

Medical Language ↔ Plain English

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)

Locations (2)

Aarhus University Hospital

Aarhus, Central Jutland, Denmark

Aalborg University Hospital

Aalborg, The North Denmark Region, Denmark

Outcomes

Primary Outcomes

The effect on fecal incontinence episode frequency

Evaluated by home recordings.

Time frame: 12 weeks

Evaluation of discomfort and on pain assessed on a Visual Analog Scale

Evaluated by home recordings.

Time frame: 12 weeks

Secondary Outcomes

Extent of constipation

Evaluated by home recordings and transabdominal rectal ultra sound.

Time frame: 12 weeks

Evaluation of urinary incontinence episodes

Evaluated by home recordings.

Time frame: 12 weeks

Evaluation of compliance assessment using the different systems

Evaluated by home recordings.

Time frame: 12 weeks

Estimation in changes of the child's well-being

Evaluated by home recordings using WHO-5

Time frame: 12 weeks

Data from ClinicalTrials.gov

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