Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-25 @ 2:39 PM
Study NCT ID:
NCT00199550
Status:
COMPLETED
Last Update Posted:
2008-07-29
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-25', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2008-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of efficacy will be determined by comparing pre and post-operative symptom scores.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Pre and post-operative objective and subjective data for each treatment group will be assessed to determine safety and efficacy. Complications related to the surgical procedure will be noted by flexible cystoscopy at 6 months.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Transurethral Resection of Prostate', 'TURP'], 'conditions': ['BPH', 'Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'This study will prospectively evaluate a new electrosurgical procedure (bipolar transurethral prostatectomy) in men with symptomatic benign prostatic hyperplasia.', 'detailedDescription': 'The purpose of this study is to demonstrate that the Bipolar TURP using the Vista Controlled Tissue Resection System is safe and efficacious as a surgical treatment for men with symptomatic BPH, allowing a reduction in the post-operative hospitalization. It is expected that bipolar TURP will be safe and efficacious for the surgical treatment of BPH and will allow a \\< 24 hour post-operative hospital stay in \\> 50% of patients undergoing this procedure.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic benign prostatic hyperplasia including patients with acute urinary retention;\n* Peak urinary flow rate \\< 12 ml/sec;\n* American Urological Association (AUA) symptom score \\> 12.\n\nExclusion Criteria:\n\n* Previous open or transurethral prostatic surgery;\n* History of urethral stricture;\n* Failure to discontinue alpha-adrenergic blocking agents for at least 14 days prior to surgery;\n* Failure to discontinue 5-alpha reductase inhibitor for at least 1 month prior to surgery;\n* Patient interested in future fertility;\n* Patient with known neurogenic bladder dysfunction;\n* Untreated urinary tract infection;\n* American Society of Anesthesiologist (ASA) Class \\>III;\n* Patients requiring anticoagulation with Coumadin or Heparin;\n* Patient unable or unwilling to comply with follow-up schedule.'}, 'identificationModule': {'nctId': 'NCT00199550', 'briefTitle': 'Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'A Prospective Randomized Clinical Trial of Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)', 'orgStudyIdInfo': {'id': 'R-04-533'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Bipolar Electrosurgical Unit', 'interventionNames': ['Procedure: Bipolar Transurethral Resection of the Prostate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Monopolar Electrosurgical Unit', 'interventionNames': ['Procedure: Monopolar Transurethral Resection of the Prostate']}], 'interventions': [{'name': 'Bipolar Transurethral Resection of the Prostate', 'type': 'PROCEDURE', 'otherNames': ['Vista, Bipolar TURP'], 'description': 'Bipolar TURP', 'armGroupLabels': ['2']}, {'name': 'Monopolar Transurethral Resection of the Prostate', 'type': 'PROCEDURE', 'otherNames': ['Monopolar TURP'], 'description': 'Monopolar TURP', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T5H 4B9', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Alberta Urology Institute Research Centre', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V5Z 3J5', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Prostate Centre at Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8R 6T9', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Can-Med Clinical Research Inc', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'L8N 1T8', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton District Urology Associaton', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K7L 3J7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': "Centre for Advanced Urological Research at Queen's University", 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Hassan Razvi, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Urology, St. Joseph's Hospital, University of Western Ontario"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'collaborators': [{'name': 'Gyrus ACMI, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Hassan Razvi', 'oldOrganization': 'The University of Western Ontario'}}}}