Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT07081906
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2025-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transdermal Versus Oral Oxybutynin in Pediatric OAB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'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': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005419', 'term': 'oxybutynin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2025-07-09', 'studyFirstSubmitQcDate': '2025-07-21', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dysfunctional Voiding and Incontinence Symptom Score (DVISS)', 'timeFrame': 'From enrollment to the end of treatment at three months', 'description': 'The primary outcome was the change in DVISS score, a validated questionnaire assessing lower urinary tract symptoms in children. Scores range from 0 to 35, with higher scores indicating more severe symptoms.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['overactive bladder', 'oxybutynin', 'transdermal', 'children', 'anticholinergic side effects'], 'conditions': ['Overactive Bladder (OAB)', 'Drug Delivery Systems', 'Anticholinergic Side Effects', 'Children and Adolescents, Boys and Girls']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized controlled clinical trial designed to compare the efficacy and safety of transdermal versus oral oxybutynin in children diagnosed with overactive bladder (OAB) who remain symptomatic despite conservative management. A total of 90 children were planned to be enrolled and randomized to receive either oral oxybutynin suspension or a transdermal oxybutynin patch. The primary outcome was defined as the change in Dysfunctional Voiding and Incontinence Symptom Score (DVISS) from baseline to the end of the treatment period. Secondary outcomes included changes in urinary frequency, voided volume, maximum flow rate (Qmax), and the incidence of adverse events. The study aimed to assess whether the transdermal route of administration provides an alternative therapeutic option with favorable tolerability in pediatric OAB patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persistent symptoms of overactive bladder (OAB) despite at least 3 months of conservative treatment (e.g., behavioral therapy, planned fluid intake, and voiding schedules)\n* No prior medical or surgical treatment for OAB\n* Ability to attend follow-up visits with family/guardian\n* Written informed consent obtained from a legal guardian\n\nExclusion Criteria:\n\n* History of febrile or recurrent urinary tract infections\n* Presence of urethral stricture\n* Known or suspected neurogenic bladder dysfunction\n* Previous bladder surgery\n* History of urolithiasis (kidney stones)\n* Contraindications to oxybutynin therapy'}, 'identificationModule': {'nctId': 'NCT07081906', 'briefTitle': 'Transdermal Versus Oral Oxybutynin in Pediatric OAB', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}, 'officialTitle': 'A Prospective and Randomized Study of Efficacy and Safety of Transdermal Oxybutynin Versus Oral Oxybutynin in The Management of Children With Overactive Bladder', 'orgStudyIdInfo': {'id': 'kartalcity_ahs_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Oxybutynin', 'description': 'Participants received oral oxybutynin suspension (5 mg, 2-3 times daily depending on body weight) for 3 months.', 'interventionNames': ['Drug: Oral Oxybutynin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transdermal oxybutynin', 'description': 'Participants received transdermal oxybutynin patch (3.9 mg/day) applied twice weekly for 3 months.', 'interventionNames': ['Drug: transdermal oxybutinin']}], 'interventions': [{'name': 'Oral Oxybutynin', 'type': 'DRUG', 'description': 'The oral form of oxybutinin was preferred for patients who had no difficulty swallowing and whose families preferred a conventional administration route. Medication was given under parental supervision to ensure adherence. Patients were monitored monthly for potential anticholinergic side effects. The patch form of oxybutinin was chosen for patients who experienced difficulties with oral intake or had previous intolerance to oral anticholinergics. Application sites were rotated to reduce the risk of local skin reactions. Families received instructions on proper patch application technique.', 'armGroupLabels': ['Oral Oxybutynin']}, {'name': 'transdermal oxybutinin', 'type': 'DRUG', 'description': 'The oral form of oxybutinin was preferred for patients who had no difficulty swallowing and whose families preferred a conventional administration route. Medication was given under parental supervision to ensure adherence. Patients were monitored monthly for potential anticholinergic side effects. The patch form of oxybutinin was chosen for patients who experienced difficulties with oral intake or had previous intolerance to oral anticholinergics. Application sites were rotated to reduce the risk of local skin reactions. Families received instructions on proper patch application technique.', 'armGroupLabels': ['Transdermal oxybutynin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34890', 'city': 'Istanbul', 'state': 'Kartal', 'country': 'Turkey (Türkiye)', 'facility': 'Kartal Dr. Lütfi Kırdar Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Ahmet H Sevinc, MD, Urology Specialist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kartal Dr. Lütfi Kırdar Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD - Urology Specialist', 'investigatorFullName': 'Ahmet Halil Sevinc', 'investigatorAffiliation': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}}}}