Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:32 PM
Study NCT ID:
NCT07149532
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2025-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biofeedback Therapy Alone Versus Biofeedback Therapy With Medical Treatment for Dysfunctional Voiding in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-24', 'studyFirstSubmitDate': '2025-08-24', 'studyFirstSubmitQcDate': '2025-08-24', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': '6 months post-procedure', 'description': 'Overall response rate will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biofeedback', 'Medical Treatment', 'Dysfunctional Voiding', 'Children']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the efficiency of biofeedback therapy alone versus biofeedback therapy with medical treatment for dysfunctional voiding in children.', 'detailedDescription': 'Dysfunctional voiding (DV) in children may result in lower urinary tract symptoms (LUTS), such as urgency, frequency, urinary incontinence, and difficulty in urination.\n\nNoninvasive assessments and biofeedback-based pelvic floor muscle training (PFMT) can effectively improve LUTS and protect upper urinary tract function in children, in addition to medical treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children less than 18 years old.\n* Both sexes.\n* Children with dysfunctional voiding.\n\nExclusion Criteria:\n\n* Patients with cognitive function impairment.\n* Patients who received any care for dysfunctional voiding.\n* Children with known anatomical anomalies of the urinary tract.\n* Children with known neurological anomalies (spinal dysraphism, multiple sclerosis, lumbar or spinal neuritis……… etc).\n* Children with a history of back or lower urinary tract trauma.'}, 'identificationModule': {'nctId': 'NCT07149532', 'briefTitle': 'Biofeedback Therapy Alone Versus Biofeedback Therapy With Medical Treatment for Dysfunctional Voiding in Children', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Biofeedback Therapy Alone Versus Biofeedback Therapy With Medical Treatment for Dysfunctional Voiding in Children: A Prospective Comparative Study', 'orgStudyIdInfo': {'id': '36264PR1112/2/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Patients will receive the biofeedback-based pelvic floor muscle training (PFMT) alone.', 'interventionNames': ['Other: Biofeedback-based pelvic floor muscle training']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Patients will receive the biofeedback-based pelvic floor muscle training (PFMT) with medical treatment.', 'interventionNames': ['Other: Biofeedback-based pelvic floor muscle training (PFMT) with medical treatment']}], 'interventions': [{'name': 'Biofeedback-based pelvic floor muscle training', 'type': 'OTHER', 'description': 'Patients will receive the biofeedback-based pelvic floor muscle training (PFMT) alone.', 'armGroupLabels': ['Group 1']}, {'name': 'Biofeedback-based pelvic floor muscle training (PFMT) with medical treatment', 'type': 'OTHER', 'description': 'Patients will receive the biofeedback-based pelvic floor muscle training (PFMT) with medical treatment.', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'status': 'RECRUITING', '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'}}}}