Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-28 @ 3:35 AM
Study NCT ID:
NCT06012903
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lower Urinary Tract Symptoms and School Functioning in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D019957', 'term': 'Motor Skills Disorders'}], 'ancestors': [{'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-06-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-12', 'studyFirstSubmitDate': '2023-07-31', 'studyFirstSubmitQcDate': '2023-08-21', 'lastUpdatePostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bladder and bowel dysfunction', 'timeFrame': 'through study completion from the parent-group, 25 minutes', 'description': 'Prevalence of lower urinary tract symptoms and/or bowel symptoms measured with the vancouver symptom score for dysfunctional elimination syndrome.'}, {'measure': 'School functioning', 'timeFrame': 'through study completion from the children-group, 30 minutes', 'description': "Quality of life in school environment, measured as the child's well-being about school functioning with the questionnaire Welbevinden."}], 'secondaryOutcomes': [{'measure': 'Influencing factors on school functioning', 'timeFrame': 'through study completion from the parent-, children- and teacher-group, 30 minutes', 'description': "Prevalence and influence of neurodevelopmental disorders, school-related factors and LUTS. Results from the vancouver symptom score for dysfunctional elimination syndrome, Developmental Coordination Disorder Questionnaire, questions concerning neurodevelopmental disorders and a questionnaire about policies and practices regarding children's toilet use and drinking habits in the classroom will be correlated with results from the questionnaire Welbevinden."}, {'measure': 'Perception of treatment characteristics', 'timeFrame': 'through study completion of the parent-group, 25 minutes', 'description': 'Perception of parents about treatment characteristics for lower urinary tract symptoms are evaluated by means of a questionnaire including questions about treatment perceptions .'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lower urinary tract symptoms', 'Quality of life', 'Pediatrics', 'neurodevelopmental disorders', 'VSSDES', 'DCD-Q'], 'conditions': ['Lower Urinary Tract Symptoms', 'Neurodevelopmental Disorders', 'Incontinence, Urinary', 'ADHD', 'ASD', 'Developmental Coordination Disorder', 'Child Development', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'Children in primary school often suffer from lower urinary tract symptoms (LUTS), which may negatively impact their overall well-being. Co-occurring neurodevelopmental disorders (NDDs) can adversely affect children as well and can cause restrictions in their daily life, especially in their school-environment.\n\nThe goal of this observational study is to identify the prevalence of LUTS in Flemish primary school children.The main questions it aims to answer are:\n\n* How prevalent are LUTS in regular primary education?\n* Is there a relation with well-being in school environment?\n* Is there an influence of co-occuring NDDs? Children, parents and teachers will be asked to fill in questionnaires related to this research question.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children following education in recruited primary, regular education schools and their respective parents/guardians and teachers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children in 4th-6th grade\n* Parents whose children are in grades 1-6\n* Teachers responsible for teaching children in grades 1-6\n* Children who attend regular primary education\n* Capable of speaking \\& comprehending Dutch\n\nExclusion Criteria:\n\n* High school students\n* home-schooled children\n* children who attend special needs education\n* Language barrier to understanding Dutch'}, 'identificationModule': {'nctId': 'NCT06012903', 'briefTitle': 'Lower Urinary Tract Symptoms and School Functioning in Children', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Epidemiological Study of Lower Urinary Tract Symptoms and School Functioning in Children in Regular Elementary School', 'orgStudyIdInfo': {'id': 'BC-11326'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Parents', 'interventionNames': ['Other: Questionnaire Vancouver symptom score for dysfunctional elimination syndrome', 'Other: Developmental Coordination Disorder Questionnaire', 'Other: Questionnaire concerning LUTS, NDDs and treatment perceptions']}, {'label': 'Children', 'interventionNames': ['Other: Questionnaire Welbevinden']}, {'label': 'Teachers', 'interventionNames': ["Other: Questionnaire about policies and practices regarding children's toilet use and drinking habits in the classroom"]}], 'interventions': [{'name': 'Questionnaire Welbevinden', 'type': 'OTHER', 'description': 'A validated questionnaire recommended by the Flemish inspection of education to measure well-being in primary school children of the 4th, 5th and 6th grade.', 'armGroupLabels': ['Children']}, {'name': 'Questionnaire Vancouver symptom score for dysfunctional elimination syndrome', 'type': 'OTHER', 'otherNames': ['VSSDES'], 'description': "Vancouver symptom score for dysfunctional elimination syndrome, Dutch version, validated by 't Hoen et al. 2016.", 'armGroupLabels': ['Parents']}, {'name': 'Developmental Coordination Disorder Questionnaire', 'type': 'OTHER', 'otherNames': ['DCD-Q'], 'description': 'Validated Developmental Coordination Disorder Questionnaire, Dutch version includes assessment of motor functioning.', 'armGroupLabels': ['Parents']}, {'name': 'Questionnaire concerning LUTS, NDDs and treatment perceptions', 'type': 'OTHER', 'description': 'Unvalidated, complementary questions including the presence of LUTS, earlier diagnosis of bladder and/or boweldysfunction and neurodevelopmental disorders and perception concerning treatment characteristics.', 'armGroupLabels': ['Parents']}, {'name': "Questionnaire about policies and practices regarding children's toilet use and drinking habits in the classroom", 'type': 'OTHER', 'description': "These unvalidated questionnaire was based on the questionnaire developed by Ko et al. (2016) about the school's policies and practices regarding children's toilet use and drinking habits in the classroom, covering students in grades one through six. Epidemiological questions related to LUTS were added to complement the questionnaire.", 'armGroupLabels': ['Teachers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'East Flanders', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Bieke Samijn, Dr.', 'role': 'CONTACT', 'email': 'Bieke.Samijn@UGent.be', 'phone': '+32 9 332 19 38'}], 'facility': 'Ghent University Hospital/Ghent University', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Bieke Samijn, PhD', 'role': 'CONTACT', 'email': 'bieke.samijn@ugent.be', 'phone': '+32 9 332 19 38'}], 'overallOfficials': [{'name': 'Ellen Vandamme, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}, {'name': 'Bieke Samijn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Ghent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}