Fecal IncontinenceNCT05032534
Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence
A study testing Cone Small, Qufora A/S and Colotip, Coloplast A/S in people with Fecal Incontinence and Constipation - Functional, run by University of Aarhus at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Fecal Incontinence, Constipation - Functional
- What is being tested?
- Cone Small, Qufora A/S and Colotip, Coloplast A/S
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesDenmark
- Study dates
- 20 Sep 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Fecal incontinence on neurogenic or non-neurogenic basis, where transanal irrigation is indicated.
Who cannot join
- Morbus Hirschsprungs disease.
- Anorectal malformations.
- Use of medication that are known to cause constipation (e.g. anticholinergics)
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aalborg University Hospital
Aalborg, The North Denmark Region, DK-9000
Aarhus University Hospital
Aarhus, Central Jutland, DK-8200
About this study
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.
Read the 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.
- Conditions
- Fecal Incontinence, Constipation - Functional
- Being tested
- Cone Small, Qufora A/S, Colotip, Coloplast A/S
- Keywords
- Transanal irrigation
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone Small, Qufora A/SDevice
Newly developed cone in a softer material and a design matching the use for transanal irrigation.
Colotip, Coloplast A/SDevice
Cone currently used for transanal irrigation at the Pediatric Ward, Aarhus University Hospital.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Cone Small, Qufora A/S; Device: Colotip, Coloplast A/S |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect on fecal incontinence episode frequency
Evaluated by home recordings.
Measured: 12 weeks
Evaluation of discomfort and on pain assessed on a Visual Analog Scale
Evaluated by home recordings.
Measured: 12 weeks
Secondary outcomes (4)
Extent of constipation
Evaluated by home recordings and transabdominal rectal ultra sound.
Measured: 12 weeks
Evaluation of urinary incontinence episodes
Evaluated by home recordings.
Measured: 12 weeks
Evaluation of compliance assessment using the different systems
Evaluated by home recordings.
Measured: 12 weeks
Estimation in changes of the child's well-being
Evaluated by home recordings using WHO-5
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start20 Sep 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital, Qufora A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032534
- Sponsor's protocol ID
- Højt skyl
- Status last verified
- Aug 2021
- First submitted
- 27 Aug 2021
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence
- ClinicalTrials.gov ID
- NCT05032534
- Acronym / sponsor ID
- Højt skyl
- Conditions
- Fecal Incontinence, Constipation - Functional
- Keywords
- Transanal irrigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital, Qufora A/S
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Newly developed cone for 6 weeks the currently used cone for 6 weeks | Active comparator | Device: Cone Small, Qufora A/S, Device: Colotip, Coloplast A/SStarts 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. |
| Currently used cone for 6 weeks the newly developed cone for 6 weeks | Active comparator | Device: Cone Small, Qufora A/S, Device: Colotip, Coloplast A/SStarts 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Fecal incontinence on neurogenic or non-neurogenic basis, where transanal irrigation is indicated.
Key exclusion criteria (3 listed)
- Morbus Hirschsprungs disease.
- Anorectal malformations.
- Use of medication that are known to cause constipation (e.g. anticholinergics)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cone Small, Qufora A/SNewly developed cone in a softer material and a design matching the use for transanal irrigation. | Device | 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/SCone currently used for transanal irrigation at the Pediatric Ward, Aarhus University Hospital. | Device | 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 |
Primary outcome
The effect on fecal incontinence episode frequency
Time frame: 12 weeks
Evaluated by home recordings.
Evaluation of discomfort and on pain assessed on a Visual Analog Scale
Time frame: 12 weeks
Evaluated by home recordings.
4 secondary outcomes
Extent of constipation
Time frame: 12 weeks
Evaluation of urinary incontinence episodes
Time frame: 12 weeks
Evaluation of compliance assessment using the different systems
Time frame: 12 weeks
Estimation in changes of the child's well-being
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cone Small, Qufora A/S and Colotip, Coloplast A/S in people with Fecal Incontinence and Constipation - Functional, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect on fecal incontinence episode frequency (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.