Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
Study NCT ID:
NCT07046156
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-01
First Post:
2025-06-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Overactive Bladder With Anticholinergic Agents
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': 'C015586', 'term': 'propiverine'}, {'id': 'D000068737', 'term': 'Tolterodine Tartrate'}], 'ancestors': [{'id': 'D010665', 'term': 'Phenylpropanolamine'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D003408', 'term': 'Cresols'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients treated with anticholinergic', 'timeFrame': '6 months'}, {'measure': 'Number of patients with drug related adverse effects', 'timeFrame': '1 month'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['overactive bladder', 'children', 'oxybutynin', 'propiverine', 'tolterodine'], 'conditions': ['Overactive Bladder']}, 'referencesModule': {'references': [{'pmid': '28265325', 'type': 'BACKGROUND', 'citation': 'Ramsay S, Bolduc S. Overactive bladder in children. Can Urol Assoc J. 2017 Jan-Feb;11(1-2Suppl1):S74-S79. doi: 10.5489/cuaj.4337.'}, {'pmid': '25408588', 'type': 'BACKGROUND', 'citation': "Park SJ, Pai KS, Kim JM, Park K, Kim KS, Song SH, Park S, Kim SO, Ryu DS, Baek M, Lee SD, Lee JW, Im YJ, Han SW, Chung JM, Cho MH, Ha TS, Cho WY, Suh HJ; Korean Children's Continence and Enuresis Society. Efficacy and tolerability of anticholinergics in Korean children with overactive bladder: a multicenter retrospective study. J Korean Med Sci. 2014 Nov;29(11):1550-4. doi: 10.3346/jkms.2014.29.11.1550. Epub 2014 Nov 4."}, {'pmid': '41182445', 'type': 'DERIVED', 'citation': 'Canbaz FA. Response to anticholinergic therapy and its predictors in pediatric overactive bladder. Eur J Pediatr. 2025 Nov 3;184(11):727. doi: 10.1007/s00431-025-06545-3.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the efficacy and adverse effect incidence of three different anticholinergics (oxybutinin, propiverine, and tolterodine) that are used in children with overactive bladder.', 'detailedDescription': 'A total of approximately 150 patients with overactive bladder will be evaluated retrospectively. Clinical and demographic data and voiding diaries of these patients will be evaluated. For this purpose, patients will be divided into mainly three groups according to the anticholinergic agent used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were treated for overactive bladder in pediatric urology clinic of Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with overactive bladder\n* Patients treated with an anticholinergic\n\nExclusion Criteria:\n\n* Presence of anatomical or neurological problems\n* Patients with missing data'}, 'identificationModule': {'nctId': 'NCT07046156', 'briefTitle': 'Treatment of Overactive Bladder With Anticholinergic Agents', 'organization': {'class': 'OTHER', 'fullName': 'Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital'}, 'officialTitle': 'Evaluation of Anticholinergic Treatment Response and Predictive Factors in Pediatric Overactive Bladder', 'orgStudyIdInfo': {'id': 'Ivstrh - OAB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oxybutynin', 'description': 'Patients treated with oxybutynin', 'interventionNames': ['Drug: Oxybutynin Cl']}, {'label': 'Propiverine', 'description': 'Patients treated with propiverine', 'interventionNames': ['Drug: propiverine']}, {'label': 'Tolterodine', 'description': 'Patients treated with tolterodine', 'interventionNames': ['Drug: Tolterodine']}], 'interventions': [{'name': 'Oxybutynin Cl', 'type': 'DRUG', 'description': 'Oxybutynin in a dose of 0.5 mg/kg will be used in the treatment of overactive bladder', 'armGroupLabels': ['Oxybutynin']}, {'name': 'propiverine', 'type': 'DRUG', 'description': 'Propiverine in a dose of 0.8 mg/kg will be used in the treatment of overactive bladder', 'armGroupLabels': ['Propiverine']}, {'name': 'Tolterodine', 'type': 'DRUG', 'description': 'Tolterodine in a dose of 0.1 mg/kg will be used in the treatment of overactive bladder', 'armGroupLabels': ['Tolterodine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sancaktepe Sehit Prof dr Ilhan Varank Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Furkan Adem Canbaz', 'investigatorAffiliation': 'Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital'}}}}