Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-28 @ 12:02 AM
Study NCT ID:
NCT04500860
Status:
COMPLETED
Last Update Posted:
2022-08-15
First Post:
2020-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Tadalafil for Treatment of Female OAB Syndrome: Short Term Follow up.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068581', 'term': 'Tadalafil'}, {'id': 'D000068737', 'term': 'Tolterodine Tartrate'}, {'id': 'D002214', 'term': 'Capsules'}], 'ancestors': [{'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'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'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-11', 'studyFirstSubmitDate': '2020-08-03', 'studyFirstSubmitQcDate': '2020-08-03', 'lastUpdatePostDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of daily low dose tadalafil 5mg in treatment of female overactive bladder syndrome: 6 months follow up', 'timeFrame': '6 months', 'description': 'Evaluation of efficacy of tadalafil 5 mg'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Female Patients With Overactive Bladder Syndrome or Female Patients With Urgency or Urgency Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'Evaluation of use of low dose tadalafil 5 mg daily for treatment of female OAB syndrome', 'detailedDescription': '90 female patients with overactive bladder syndrome divided into 3 groups group A subjected to daily low dose tadalafil 5 mg ,group B subjected to tolterodine and group C to placebo. They are evaluated as using OAB symptoms score for 6 months follow up'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any female with overactive bladder syndrome, urgency with or without urgency urinary incontinence\n\nExclusion Criteria:\n\n* Active Urinary tract infection\n* neurologic abnormality\n* Pure Stress urinary incontinence'}, 'identificationModule': {'nctId': 'NCT04500860', 'briefTitle': 'Low Dose Tadalafil for Treatment of Female OAB Syndrome: Short Term Follow up.', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Low Dose Tadalafil 5mg for Treatment of Female Overactive Bladder Syndrome :6 Months Follow up', 'orgStudyIdInfo': {'id': 'Cairo University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A Tadalafil 5 mg', 'description': '30 patients subjected to Daily dose of tadalafil 5mg', 'interventionNames': ['Drug: Low dose tadalafil 5 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B Tolterodine', 'description': '30 patients subjected to tolterodine 4 mg daily', 'interventionNames': ['Drug: Tolterodine 4 Mg Oral Capsule, Extended Release']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group C placebo', 'description': '30 patients subjected to placebo daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Low dose tadalafil 5 mg', 'type': 'DRUG', 'description': 'Efficacy of daily low dose tadalafil 5mg for treatment of female overactive bladder syndrome or urgency with or without urgency urinary incontinence', 'armGroupLabels': ['Group A Tadalafil 5 mg']}, {'name': 'Tolterodine 4 Mg Oral Capsule, Extended Release', 'type': 'DRUG', 'description': 'To compare efficacy of low dose tadalafil 5 mg to tolterodine 4 mg extended release in treatment of female overactive bladder', 'armGroupLabels': ['Group B Tolterodine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo drugs', 'armGroupLabels': ['Group C placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12334', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Samer Morsy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Urology lecturer', 'investigatorFullName': 'Samer Morsy', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}