Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2025-12-26 @ 1:09 AM
Study NCT ID:
NCT06184334
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2023-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Management of OAB in Female Patients .
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': 'C520025', 'term': 'mirabegron'}, {'id': 'D000068581', 'term': 'Tadalafil'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-29', 'studyFirstSubmitDate': '2023-12-14', 'studyFirstSubmitQcDate': '2023-12-27', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overactive bladder symptoms score (OABSS)', 'timeFrame': 'three months', 'description': 'OABSS is a symptom assessment questionnaire designed to quantify OAB symptoms into a single score The questionnaire consists of 4 questions on OAB symptoms with maximum scores ranging from 2 to 5: daytime frequency (2 points), night-time frequency (3 points), urgency (5 points), and UUI (5 points). The total score ranges from 0 to 15 points, with higher scores indicating higher symptom severity.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the effectiveness of mirabegron, solifenacin, tadalafil (5mg), and their combination in relieving symptoms of overactive bladder (OAB) in a double-blinded prospective randomized placebo-controlled trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women from 18 to 65 years of age with LUTs due to OAB\n\nExclusion Criteria:\n\n* Severe cardiovascular disorders. \\\\\n\n * Severe neurogenic dysfunction.\n * Drug administration which interfere with bladder function .\n * Abnormal bleeding profile.\n * A verified urinary tract infection as determined by urinalysis and/or urine culture during screening'}, 'identificationModule': {'nctId': 'NCT06184334', 'briefTitle': 'Management of OAB in Female Patients .', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Assessment of Efficacy of Mirabegron, Solifenacin, Tadalafil 5mg and Combination Therapy in Female Patients With Overactive Bladder: A Double Blinded Prospective Randomized Placebo -Controlled Trial', 'orgStudyIdInfo': {'id': 'OAB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A : patients will receive mirabegron', 'description': 'patients will receive mirabegron', 'interventionNames': ['Drug: Mirabegron']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B: patients will receive tadalafil 5mg', 'description': 'patients will receive tadalafil 5mg', 'interventionNames': ['Drug: Tadalafil 5mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C: patients will receive solfenacin', 'description': 'patients will receive solfenacin', 'interventionNames': ['Drug: Solfenacin']}], 'interventions': [{'name': 'Solfenacin', 'type': 'DRUG', 'description': 'pills taken once day', 'armGroupLabels': ['Group C: patients will receive solfenacin']}, {'name': 'Mirabegron', 'type': 'DRUG', 'description': 'pills taken once day', 'armGroupLabels': ['Group A : patients will receive mirabegron']}, {'name': 'Tadalafil 5mg', 'type': 'DRUG', 'description': 'pills taken once day', 'armGroupLabels': ['Group B: patients will receive tadalafil 5mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kafr ash Shaykh', 'country': 'Egypt', 'facility': 'Kafrelsheikh University hospital', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elsayed Abdelhalim Elsayed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer, urology department, Kafrelsheikh university', 'investigatorFullName': 'Elsayed Abdelhalim Elsayed', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}