Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-26 @ 11:21 PM
Study NCT ID:
NCT03280420
Status:
COMPLETED
Last Update Posted:
2017-09-25
First Post:
2017-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Versus Late Catheter Removal in Patients With Acute Urinary Retention Secondary to BPH Under Tamsulosin Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-10-24', 'releaseDate': '2017-09-26'}, {'resetDate': '2018-08-03', 'releaseDate': '2017-10-29'}], 'estimatedResultsFirstSubmitDate': '2017-09-26'}}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-10', 'size': 205569, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-09-16T11:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All patients were catheterized and received urinary antiseptic and then randomly divided into two groups : Group I :30 patients received Tamsulosin 0.4 mg once daily and catheter removed after 3 days. Group II :30 patients received Tamsulosin 0.4 mg once daily and catheter removed after 7 days.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-20', 'studyFirstSubmitDate': '2017-08-12', 'studyFirstSubmitQcDate': '2017-09-09', 'lastUpdatePostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The duration for trial without catheter', 'timeFrame': '6 Months', 'description': 'To determine the optimum period to remove catheter in patients complaining of acute urinary retention with benign prostatic hyperplasia.'}], 'secondaryOutcomes': [{'measure': 'Factor affecting trial without catheter', 'timeFrame': '6 Months', 'description': "To evaluate the role of the following in trial without catheter patient's age prostate size residual urine volume prostatic specific antigen (PSA)"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute urinary retention', 'BPH', 'TWOC', 'Tamsulosin'], 'conditions': ['BPH With Urinary Obstruction']}, 'descriptionModule': {'briefSummary': 'The aim of this work is to compare between early (3days) and late(7days) removal of urinary catheter after acute urine retention in patients with Benign Prostatic Hyperplasia under Tamsulosin treatment.', 'detailedDescription': 'This is a prospective randomized study, Men with acute urinary retention secondary to benign prostatic hyperplasia were catheterized and then, if they fulfilled the entry criteria, were randomly assigned to receive 0.4 mg tamsulosin hydrochloride for three days or seven days, After that the catheter was removed and the ability to void unaided assessed.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having first attack of acute urinary retention secondary to BPH.\n\nExclusion Criteria:\n\n* Renal impairment.\n* Suspected urethral stricture.\n* Neurogenic bladder.\n* Cancer prostate.\n* Medically induced retention.\n* Previous use of alpha blockers.\n* History of drug hypersensitivity or allergy to Tamsulosin.'}, 'identificationModule': {'nctId': 'NCT03280420', 'briefTitle': 'Early Versus Late Catheter Removal in Patients With Acute Urinary Retention Secondary to BPH Under Tamsulosin Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Early Versus Late Catheter Removal in Patients With Acute Urinary Retention Secondary to Benign Prostatic Hyperplasia Under Tamsulosin Treatment', 'orgStudyIdInfo': {'id': '123urology'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'early catheter removal', 'description': '30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 3 days.', 'interventionNames': ['Procedure: Early catheter removal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'late catheter removal', 'description': '30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 7 days.', 'interventionNames': ['Procedure: Late catheter removal']}], 'interventions': [{'name': 'Early catheter removal', 'type': 'PROCEDURE', 'otherNames': ['After 3 days catheter removal'], 'description': 'Patients will receive selective alpha blocker ( tamsulosin 0.4mg ) once daily and the catheter will be removed after 3 days.\n\nAfter catheter removal, patients will be allowed to void and will be discharged home who will have a successful void more than 200 cc of urine. Patients who will fail to void will be re-catheterized and will be prepared for prostatectomy.', 'armGroupLabels': ['early catheter removal']}, {'name': 'Late catheter removal', 'type': 'PROCEDURE', 'otherNames': ['After 7 days catheter removal'], 'description': 'Patients will receive selective alpha blocker ( tamsulosin 0.4mg ) once daily and the catheter will be removed after 7 days.\n\nAfter catheter removal, patients will be allowed to void and will be discharged home who will have a successful void more than 200 cc of urine. Patients who will fail to void will be re-catheterized and will be prepared for prostatectomy.', 'armGroupLabels': ['late catheter removal']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'El Mokhayam El Daem St.، Ezbet El-Arab, Nasr City, Cairo', 'country': 'Egypt', 'facility': 'Faculty of medicine ,Al Azhar university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohamed M Badr, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Al-Azhar University'}, {'name': 'Mohamed F El Saeed El Ebiary, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Al-Azhar University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Salem Hassan Salem Mohamed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Cairo, Egypt', 'investigatorFullName': 'Salem Hassan Salem Mohamed', 'investigatorAffiliation': 'Al-Azhar University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-09-26', 'type': 'RELEASE'}, {'date': '2017-10-24', 'type': 'RESET'}, {'date': '2017-10-29', 'type': 'RELEASE'}, {'date': '2018-08-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Salem Hassan Salem Mohamed, Cairo, Egypt, Al-Azhar University'}}}}