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

Primary Purpose

Fecal Incontinence, Constipation - Functional

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Cone Small, Qufora A/S

Colotip, Coloplast A/S

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring Transanal irrigation

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Aarhus University Hospital
Aalborg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

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

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The effect on fecal incontinence episode frequency

Evaluated by home recordings.

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

Evaluated by home recordings.

Secondary Outcome Measures

Extent of constipation

Evaluated by home recordings and transabdominal rectal ultra sound.

Evaluation of urinary incontinence episodes

Evaluated by home recordings.

Evaluation of compliance assessment using the different systems

Evaluated by home recordings.

Estimation in changes of the child's well-being

Evaluated by home recordings using WHO-5

Full Information

NCT ID

NCT05032534

First Posted

August 27, 2021

Last Updated

August 8, 2022

Sponsor

University of Aarhus

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05032534

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

September 20, 2021 (Actual)

Primary Completion Date

July 31, 2022 (Actual)

Study Completion Date

July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fecal Incontinence, Constipation - Functional

Keywords

Transanal irrigation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Active Comparator

Arm Description

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.

Arm Title

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

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Cone Small, Qufora A/S

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Colotip, Coloplast A/S

Intervention Description

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

Primary Outcome Measure Information:

Title

The effect on fecal incontinence episode frequency

Description

Evaluated by home recordings.

Time Frame

12 weeks

Title

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

Description

Evaluated by home recordings.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Extent of constipation

Description

Evaluated by home recordings and transabdominal rectal ultra sound.

Time Frame

12 weeks

Title

Evaluation of urinary incontinence episodes

Description

Evaluated by home recordings.

Time Frame

12 weeks

Title

Evaluation of compliance assessment using the different systems

Description

Evaluated by home recordings.

Time Frame

12 weeks

Title

Estimation in changes of the child's well-being

Description

Evaluated by home recordings using WHO-5

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Facility Information:

Facility Name

Aarhus University Hospital

City

Aarhus

State/Province

Central Denmark Region

ZIP/Postal Code

DK-8200

Country

Denmark

Facility Name

Aalborg University Hospital

City

Aalborg

State/Province

The North Denmark Region

ZIP/Postal Code

DK-9000

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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