Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:34 PM
Study NCT ID:
NCT07424651
Status:
COMPLETED
Last Update Posted:
2026-02-20
First Post:
2026-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hidden Link Between Meatal Stenosis and Primary Nocturnal Enuresis in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-14', 'studyFirstSubmitDate': '2026-02-14', 'studyFirstSubmitQcDate': '2026-02-14', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between Meatal Stenosis and primary nocturnal enuresis', 'timeFrame': '3 years from collecting the data from the database', 'description': 'Association between Meatal Stenosis and primary nocturnal enuresis was assessed to determine whether there is a significant relationship between the presence of meatal stenosis and the occurrence of primary nocturnal enuresis in male children aged 7-12 years.'}], 'secondaryOutcomes': [{'measure': 'Resolution of primary nocturnal enuresis post-meatoplasty', 'timeFrame': '3 years from collecting the data from the database', 'description': 'Resolution of primary nocturnal enuresis post-meatoplasty was assessed to assess the effectiveness of meatoplasty in resolving primary nocturnal enuresis in children with meatal stenosis.'}, {'measure': 'Need for Revision Meatoplasty', 'timeFrame': '3 years from collecting the data from the database', 'description': 'Need for Revision Meatoplasty was assessed in patients due to persistent or recurrent meatal stenosis after the initial surgery.'}, {'measure': 'Prevalence of Meatal Stenosis in primary nocturnal enuresis patients', 'timeFrame': '3 years from collecting the data from the database', 'description': 'Prevalence of Meatal Stenosis in primary nocturnal enuresis patients was assessed among children diagnosed with primary nocturnal enuresis within the study period (2021-2024).'}, {'measure': 'Incidence of complications', 'timeFrame': '3 years from collecting the data from the database', 'description': 'Any complications or adverse events following meatoplasty, including infection, scarring, or urinary retention were recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meatal Stenosis', 'Primary Nocturnal Enuresis', 'Children']}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate the association between meatal stenosis and primary nocturnal enuresis severity, and evaluated therapeutic outcomes following surgical correction.', 'detailedDescription': 'Primary nocturnal enuresis (PNE) is a prevalent pediatric condition characterized by involuntary urination during sleep in children aged five years or older who have never achieved consistent nighttime dryness. The prevalence of PNE decreases with age, affecting approximately 15% of five-year-old and decreasing to 1-2% by adolescence.\n\nMeatal stenosis, defined as the pathological narrowing of the urethral meatus, is an underexplored potential factor. This condition is known to cause obstructed urinary flow, incomplete bladder emptying, and increased bladder pressure, all of which may contribute to enuresis.\n\nThe incidence of meatal stenosis is higher in circumcised males but can also occur in uncircumcised males and females due to inflammation, trauma, or infection'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This retrospective study population includes male children aged 7-12 years who presented with primary nocturnal enuresis at a pediatric urology clinic between October 2022 and December 2024.', 'genderDescription': 'Males diagnosed with primary nocturnal enuresis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male children aged 7-12 years.\n* Diagnosed with primary nocturnal enuresis.\n* Evaluated and treated at the study center between January 2021 and December 2024.\n* Confirmed diagnosis of meatal stenosis based on clinical examination and uroflowmetry when indicated.\n* Patients who underwent meatoplasty and completed the prescribed follow-up period.\n\nExclusion Criteria:\n\n* Secondary enuresis (previously dry for ≥ 6 months before recurrence of bedwetting).\n* Known neurological disorders (e.g., spina bifida, cerebral palsy) or developmental delays.\n* Structural anomalies of the urinary tract other than meatal stenosis (e.g., posterior urethral valves, vesicoureteral reflux).\n* Children who did not complete the follow-up or had incomplete clinical records.'}, 'identificationModule': {'nctId': 'NCT07424651', 'briefTitle': 'Hidden Link Between Meatal Stenosis and Primary Nocturnal Enuresis in Children', 'organization': {'class': 'OTHER', 'fullName': 'New Valley University'}, 'officialTitle': 'Investigating the Hidden Link Between Meatal Stenosis and Primary Nocturnal Enuresis in Children', 'orgStudyIdInfo': {'id': '2025130002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Patients who underwent meatoplasty.', 'interventionNames': ['Procedure: Meatoplasty Primary nocturnal enuresis.']}], 'interventions': [{'name': 'Meatoplasty Primary nocturnal enuresis.', 'type': 'PROCEDURE', 'description': 'Patients diagnosed with primary nocturnal enuresis.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72511', 'city': 'New Valley', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'New Valley University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'The data will be available upon a reasonable request from the corresponding author.', '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': 'After the end of study for one year.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Urology, Faculty of medicine, New Vally University, New Vally, Egypt', 'investigatorFullName': 'Waheed Fawzy Abdelrasol', 'investigatorAffiliation': 'New Valley University'}}}}