Skip to main content
OpenTrials
Completed

NCT Number: NCT05032534

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fecal Incontinence Constipation - Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Aarhus, Central Jutland, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cone Small, Qufora A/S

Device

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

Colotip, Coloplast A/S

Device

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

Primary outcomes

  1. The effect on fecal incontinence episode frequency

    Time frame: 12 weeks

    Evaluated by home recordings.

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

    Time frame: 12 weeks

    Evaluated by home recordings.

Secondary outcomes

  1. Extent of constipation

    Time frame: 12 weeks

    Evaluated by home recordings and transabdominal rectal ultra sound.

  2. Evaluation of urinary incontinence episodes

    Time frame: 12 weeks

    Evaluated by home recordings.

  3. Evaluation of compliance assessment using the different systems

    Time frame: 12 weeks

    Evaluated by home recordings.

  4. Estimation in changes of the child's well-being

    Time frame: 12 weeks

    Evaluated by home recordings using WHO-5

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Qufora A/S

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 2, 2021
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.