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

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05032534
• Other study ID #: Højt skyl
• Status: Completed
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: August 2021
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Constipation
• Constipation - Functional
• Fecal Incontinence

Intervention

Device:
• Cone Small, Qufora A/S
Newly developed cone in a softer material and a design matching the use for transanal irrigation.
• Colotip, Coloplast A/S
Cone currently used for transanal irrigation at the Pediatric Ward, Aarhus University Hospital.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg	The North Denmark Region
Denmark	Aarhus University Hospital	Aarhus	Central Denmark Region

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg University Hospital, Aarhus University Hospital, Qufora A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect on fecal incontinence episode frequency	Evaluated by home recordings.	12 weeks
Primary	Evaluation of discomfort and on pain assessed on a Visual Analog Scale	Evaluated by home recordings.	12 weeks
Secondary	Extent of constipation	Evaluated by home recordings and transabdominal rectal ultra sound.	12 weeks
Secondary	Evaluation of urinary incontinence episodes	Evaluated by home recordings.	12 weeks
Secondary	Evaluation of compliance assessment using the different systems	Evaluated by home recordings.	12 weeks
Secondary	Estimation in changes of the child's well-being	Evaluated by home recordings using WHO-5	12 weeks