Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-30 @ 4:18 AM
Study NCT ID:
NCT05032534
Status:
COMPLETED
Last Update Posted:
2022-08-09
First Post:
2021-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005242', 'term': 'Fecal Incontinence'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The children will use either the old or the new cone for transanal irrigation for 6 weeks and then crossover to the contrary cone.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-08', 'studyFirstSubmitDate': '2021-08-27', 'studyFirstSubmitQcDate': '2021-08-27', 'lastUpdatePostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect on fecal incontinence episode frequency', 'timeFrame': '12 weeks', 'description': 'Evaluated by home recordings.'}, {'measure': 'Evaluation of discomfort and on pain assessed on a Visual Analog Scale', 'timeFrame': '12 weeks', 'description': 'Evaluated by home recordings.'}], 'secondaryOutcomes': [{'measure': 'Extent of constipation', 'timeFrame': '12 weeks', 'description': 'Evaluated by home recordings and transabdominal rectal ultra sound.'}, {'measure': 'Evaluation of urinary incontinence episodes', 'timeFrame': '12 weeks', 'description': 'Evaluated by home recordings.'}, {'measure': 'Evaluation of compliance assessment using the different systems', 'timeFrame': '12 weeks', 'description': 'Evaluated by home recordings.'}, {'measure': "Estimation in changes of the child's well-being", 'timeFrame': '12 weeks', 'description': 'Evaluated by home recordings using WHO-5'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transanal irrigation'], 'conditions': ['Fecal Incontinence', 'Constipation - Functional']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "This is a randomized, controlled study.\n\nThis study will be performed at Aarhus University Hospital (Denmark) and Aalborg University Hospital (Denmark) following the same protocol.\n\nAccording 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fecal incontinence on neurogenic or non-neurogenic basis, where transanal irrigation is indicated.\n\nExclusion Criteria:\n\n* Morbus Hirschsprungs disease.\n* Anorectal malformations.\n* Use of medication that are known to cause constipation (e.g. anticholinergics)'}, 'identificationModule': {'nctId': 'NCT05032534', 'briefTitle': 'Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence', 'orgStudyIdInfo': {'id': 'Højt skyl'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Newly developed cone for 6 weeks the currently used cone for 6 weeks', '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.', 'interventionNames': ['Device: Cone Small, Qufora A/S', 'Device: Colotip, Coloplast A/S']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Currently used cone for 6 weeks the newly developed cone for 6 weeks', '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.', 'interventionNames': ['Device: Cone Small, Qufora A/S', 'Device: Colotip, Coloplast A/S']}], 'interventions': [{'name': 'Cone Small, Qufora A/S', 'type': 'DEVICE', 'description': 'Newly developed cone in a softer material and a design matching the use for transanal irrigation.', 'armGroupLabels': ['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']}, {'name': 'Colotip, Coloplast A/S', 'type': 'DEVICE', 'description': 'Cone currently used for transanal irrigation at the Pediatric Ward, Aarhus University Hospital.', 'armGroupLabels': ['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']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-8200', 'city': 'Aarhus', 'state': 'Central Jutland', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': 'DK-9000', 'city': 'Aalborg', 'state': 'The North Denmark Region', 'country': 'Denmark', 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, {'name': 'Qufora A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}