Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-30 @ 4:15 PM
Study NCT ID:
NCT06788704
Status:
COMPLETED
Last Update Posted:
2025-01-28
First Post:
2025-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tadalafil Daily Used Post Turp
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-25', 'studyFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2025-01-17', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess erectile function', 'timeFrame': 'One month', 'description': 'Using IIEF score'}, {'measure': 'Assess erectile function', 'timeFrame': '3 month', 'description': 'Usine IIEF score'}], 'secondaryOutcomes': [{'measure': 'Assess storage symptoms', 'timeFrame': 'One month', 'description': 'Using IPSS Score'}, {'measure': 'Assess storage symptoms', 'timeFrame': '3 month', 'description': 'Using IPSS score'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erectile Dysfunction Following Urethral Surgery']}, 'referencesModule': {'references': [{'pmid': '40588736', 'type': 'DERIVED', 'citation': 'Taha DE, Nabeeh H, Zeinelabden KM, Abdelhalim E, Elmekawy S, Samaha II, Behiry A, Elmoaty AA, Abdelbaky T, Ibrahim A. The effect of tadalafil 5 mg on erection and persistent storage lower urinary tract symptoms after transurethral resection of prostate: a randomized controlled study. Basic Clin Androl. 2025 Jul 1;35(1):27. doi: 10.1186/s12610-025-00273-2.'}]}, 'descriptionModule': {'briefSummary': 'to assess the effect of early tadalafil 5 mg once daily on persistent storage lower urinary tract symptoms (LUTS) and erectile function after transurethral resection of the prostate (TURP).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Sexual active male patients underwent TURP', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sexual active men\n\nExclusion Criteria:\n\n* sexual inactive men\n* cardiac patients'}, 'identificationModule': {'nctId': 'NCT06788704', 'briefTitle': 'Tadalafil Daily Used Post Turp', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'The Effect of Tadalafil 5 mg on Erection and Persistent Storage Lower Urinary Tract Symptoms After Transurethral Resection of Prostate: a Randmized Controlled Trial', 'orgStudyIdInfo': {'id': 'Tadalafil daily used post turp'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient recive tadalafil 5mg once daily early post turp', 'interventionNames': ['Drug: Tadalafil 5mg']}, {'label': 'Patient recive placebo once daily early post turp', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tadalafil 5mg', 'type': 'DRUG', 'description': 'Patient recive tadalafil 5mg once daily early post turp', 'armGroupLabels': ['Patient recive tadalafil 5mg once daily early post turp']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patient recive placebo once daily early post turp', 'armGroupLabels': ['Patient recive placebo once daily early post turp']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44749', 'city': 'Zagazig', 'country': 'Egypt', 'facility': 'Elsayed Abdelhalim Elsayed', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer of urology', 'investigatorFullName': 'Elsayed Abdelhalim Elsayed', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}