Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-03 @ 9:25 AM
Study NCT ID:
NCT07067957
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Functional Lower Urinary Tract Voiding Dysfunction in School-Aged Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'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': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-06', 'studyFirstSubmitDate': '2025-07-06', 'studyFirstSubmitQcDate': '2025-07-06', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Voiding Dysfunction', 'timeFrame': '1 Hour after completion of the questionnaire', 'description': 'Prevalence of Voiding Dysfunction Among School-Aged Children will be Measured using the validated Arabic version of the Dysfunctional Voiding Symptom Score (DVSS). Children with a score above the diagnostic threshold will be considered as having voiding dysfunction.'}], 'secondaryOutcomes': [{'measure': 'Frequency of Constipation in Children With Voiding Dysfunction', 'timeFrame': '1 Hour after completion of the questionnaire', 'description': 'Constipation history will be identified through the Dysfunctional Voiding Symptom Score (DVSS) questionnaire and confirmed during clinical evaluation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Voiding Dysfunction', 'Urinary Incontinence', 'Urination Disorders', 'Lower Urinary Tract Symptoms', 'Pediatrics', 'Constipation']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the prevalence of voiding disorders and the related risk factors for the primary school-age children in El Ghrbia Government', 'detailedDescription': 'Lower urinary tract dysfunction (LUTD) is classified as a storage and voiding symptoms. Storage symptoms are increased or decreased urinary frequency, urinary incontinence, urinary urgency, and nocturia. Voiding symptoms are classified as hesitation, straining, weak stream, and intermittency. Other symptoms are holding maneuvers, feeling of incomplete emptying, postmicturition dribble, and genital and lower urinary tract pain. Constipation and/or fecal incontinence are closely related to LUTD, among children over 5 years due to functional or nonorganic causes.\n\nThe exact prevalence of the lower urinary tract dysfunction (LUTD) is unknown, approximately 20% to 30% of children in the world have symptoms associated with voiding disorders. In epidemiological studies, this ratio is between 2.1% and 19.2% in school-age children.Due to the modern lifestyle, the prevalence increases secondary to changes in toilet training and habits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'School-aged children (4-14 years) attending primary schools in El Gharbia Governorate, Egypt, during the study period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 4-14 years old in our locality.\n\nExclusion Criteria:\n\n* Children with known anatomical anomalies of urinary tract\n* Children with known neurological anomalies (spinal dysraphism, multiple sclerosis, lumbar or spinal neuritis……… etc)\n* Children with history of back or lower urinary tract trauma\n* Parents who refuse participation'}, 'identificationModule': {'nctId': 'NCT07067957', 'briefTitle': 'Prevalence of Functional Lower Urinary Tract Voiding Dysfunction in School-Aged Children', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Prevalence of Functional Lower Urinary Tract Voiding Dysfunction in School-Aged Children', 'orgStudyIdInfo': {'id': '36264PR1073/1/25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'School-aged Children', 'interventionNames': ['Other: Arabic Dysfunctional Voiding Symptom Score Questionnaire (DVSS)']}], 'interventions': [{'name': 'Arabic Dysfunctional Voiding Symptom Score Questionnaire (DVSS)', 'type': 'OTHER', 'description': 'A validated Arabic version of the Dysfunctional Voiding Symptom Score Questionnaire (DVSS) questionnaire will be used to screen children for symptoms of lower urinary tract dysfunction. It includes 10 items assessing urinary and bowel habits.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed I Elmaadawy, MD', 'role': 'CONTACT', 'email': 'Mohamed.elmaadawy@med.tanta.edu.eg', 'phone': '00201060245430'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Mohamed I Elmaadawy, MD', 'role': 'CONTACT', 'email': 'Mohamed.elmaadawy@med.tanta.edu.eg', 'phone': '00201060245430'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Mohamed Ibrahim Ahmed Elmaadawy', 'investigatorAffiliation': 'Tanta University'}}}}