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.

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence; Constipation - Functional
• Intervention / Treatment: Device: Cone Small, Qufora A/S; Device: Colotip, Coloplast A/S

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Central Denmark Region
    • Aarhus, Central Denmark Region, Denmark, DK-8200
      • Aarhus University Hospital
  • The North Denmark Region
    • Aalborg, The North Denmark Region, Denmark, DK-9000
      • Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Newly developed cone for 6 weeks the currently used cone for 6 weeks; 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; Newly developed cone in a softer material and a design matching the use for transanal irrigation.; Device: Colotip, Coloplast A/S; Cone currently used for transanal irrigation at the Pediatric Ward, Aarhus University Hospital.
Active Comparator: Currently used cone for 6 weeks the newly developed cone for 6 weeks; 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; Newly developed cone in a softer material and a design matching the use for transanal irrigation.; Device: Colotip, Coloplast A/S; Cone currently used for transanal irrigation at the Pediatric Ward, Aarhus University Hospital.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; Aalborg University Hospital; Qufora A/S

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Transanal irrigation
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Constipation; Fecal Incontinence
• Other Study ID Numbers: Højt skyl

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No