Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-01-22 @ 11:22 AM
Study NCT ID:
NCT04503850
Status:
UNKNOWN
Last Update Posted:
2020-08-10
First Post:
2020-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Mirabegron on Erectile Function in BPH Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C520025', 'term': 'mirabegron'}, {'id': 'D000317', 'term': 'Adrenergic alpha-Antagonists'}], 'ancestors': [{'id': 'D018674', 'term': 'Adrenergic Antagonists'}, {'id': 'D018663', 'term': 'Adrenergic Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-06', 'studyFirstSubmitDate': '2020-08-03', 'studyFirstSubmitQcDate': '2020-08-05', 'lastUpdatePostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of Mirabegron on erectile function', 'timeFrame': '6 months', 'description': 'Using international index of erectile function 5 score system , least score 5 means severe erectile dysfunction and highest score 25 means no erectile dysfunction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Males With Benign Prostatic Hyperplasia Symptoms']}, 'descriptionModule': {'briefSummary': 'Evaluation of impact of Mirabegron on erectile function for patients treated for BPH', 'detailedDescription': '50 patients (Group A) will receive Mirabegron \\& alpha blocker 50 patients (Group B) will receive alpha blocker only Evaluation using IIEF 5 scoring system'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All males above age of 50 with LUTS due to BPH', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All males above age 50 with LUTS due to BPH not candidate for prostatectomy\n\nExclusion Criteria:\n\n* males below age 50\n* neurologic abnormality\n* Any indication for prostatectomy\n* abnormal bladder contractility i.e diabetics'}, 'identificationModule': {'nctId': 'NCT04503850', 'briefTitle': 'Impact of Mirabegron on Erectile Function in BPH Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Impact of Beta 3 Agonist Mirabegron on Erectile Function on Patients With Benign Prostate Hyperplasia', 'orgStudyIdInfo': {'id': 'Cairo University Hospitals'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A Mirabegron', 'description': '50 patients receiving Mirabegron 50 mg once daily \\& alpha blocker', 'interventionNames': ['Drug: Mirabegron 50 MG']}, {'label': 'Group B alpha blocker only', 'description': '50 patients receiving alpha blocker only', 'interventionNames': ['Drug: Alpha Blockers']}], 'interventions': [{'name': 'Mirabegron 50 MG', 'type': 'DRUG', 'description': 'Mirabegron 50 mg daily dose and follow Up of erectile function using international index of erectile function 5 scoring system', 'armGroupLabels': ['Group A Mirabegron']}, {'name': 'Alpha Blockers', 'type': 'DRUG', 'description': 'Alpha blocker daily and evaluation of erectile function using international index of erectile function 5 scoring system', 'armGroupLabels': ['Group B alpha blocker only']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Urology Consultant', 'investigatorFullName': 'Samer Morsy', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}