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

NCT05032534 | Completed

• 1 other identifier: Højt skyl
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Fecal Incontinence; Constipation - Functional

Keywords

Transanal irrigation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Extent of constipation

  12 weeks

• Evaluation of urinary incontinence episodes

  12 weeks

• Evaluation of compliance assessment using the different systems

  12 weeks

• Estimation in changes of the child's well-being

  12 weeks

Study Arms (2)

Newly developed cone for 6 weeks the currently used cone for 6 weeks

ACTIVE COMPARATOR

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; Device: Colotip, Coloplast A/S

Currently used cone for 6 weeks the newly developed cone for 6 weeks

ACTIVE COMPARATOR

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; Device: Colotip, Coloplast A/S

Interventions

Cone Small, Qufora A/S DEVICE

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

Currently used cone for 6 weeks the newly developed cone for 6 weeks; Newly developed cone for 6 weeks the currently used cone for 6 weeks

Colotip, Coloplast A/S DEVICE

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

Currently used cone for 6 weeks the newly developed cone for 6 weeks; Newly developed cone for 6 weeks the currently used cone for 6 weeks

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Fecal incontinence on neurogenic or non-neurogenic basis, where transanal irrigation is indicated.

You may not qualify if:

• Morbus Hirschsprungs disease.
• Anorectal malformations.
• Use of medication that are known to cause constipation (e.g. anticholinergics)

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Aalborg University Hospital: collaborator
• Qufora A/S: collaborator

Study Sites (2)

Aarhus University Hospital

Aarhus, Central Jutland, DK-8200, Denmark

Location

Aalborg University Hospital

Aalborg, The North Denmark Region, DK-9000, Denmark

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The children will use either the old or the new cone for transanal irrigation for 6 weeks and then crossover to the contrary cone.

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 2, 2021
• Study Start: September 20, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: August 9, 2022

Record last verified: 2021-08

Locations

DK (2)