Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT00877669
Status:
COMPLETED
Last Update Posted:
2019-12-02
First Post:
2009-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020728', 'term': 'Transurethral Resection of Prostate'}], 'ancestors': [{'id': 'D011468', 'term': 'Prostatectomy'}, {'id': 'D013521', 'term': 'Urologic Surgical Procedures, Male'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 313}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-28', 'studyFirstSubmitDate': '2009-04-06', 'studyFirstSubmitQcDate': '2009-04-07', 'lastUpdatePostDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The changes of International Prostatic Symptom Scores (IPSS) from baseline to 6 months after operation', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'The changes of Quality of Life (QoL) parameters', 'timeFrame': '6 months'}, {'measure': 'The changes of IPSS and QoL parameters', 'timeFrame': '1 month and 3months after operation'}, {'measure': 'The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR) parameters', 'timeFrame': '2 weeks and 3 and 6 months after operation'}, {'measure': 'Postoperative hospital stay days and postoperative catheterization days', 'timeFrame': 'immediate postoperative period'}, {'measure': 'The changes of the hemoglobin and the serum sodium', 'timeFrame': '0 and 1 day after operation'}, {'measure': 'Operative time and Resected tissue weight', 'timeFrame': '0 day after operation'}, {'measure': 'The changes of ICS male questionnaire (short form) parameters', 'timeFrame': '3 and 6 months after operation'}, {'measure': 'The changes of international index of erectile function (IIEF)-15 parameters', 'timeFrame': '6 months after operation'}, {'measure': 'The changes of Patient perception of treatment benefit questionnaire (PPTB) parameters', 'timeFrame': '3 and 6 months after operation'}, {'measure': 'The changes of voiding frequencies and urgency parameters in Frequency volume chart', 'timeFrame': '3 and 6 months after operation'}, {'measure': 'Ejaculation parameter', 'timeFrame': '6 months after operation'}, {'measure': 'Complications', 'timeFrame': 'During all study periods'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lower Urinary Tract Symptoms', 'Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare of Efficacy and Safety Between Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate Hyperplasia (BPH).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 50 yrs or greater\n* International prostatic symptom score \\>= 12\n* Bladder outlet obstruction confirmed by pressure-flow study (BOOI \\> 20)\n* Able to give fully informed consent\n\nExclusion Criteria:\n\n* Patients with urologic malignancies such as prostate cancer and bladder cancer\n* Patients underwent urethral, prostate surgery\n* Patients with urethral stricture or bladder diverticulum or bladder neck contracture\n* Patients with histories of bacterial prostatitis within 1 year\n* seems not to be appropriate to this study by the decision of investigators because of any other reasons'}, 'identificationModule': {'nctId': 'NCT00877669', 'briefTitle': 'Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'The Comparison of Efficacy Between Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate Hyperplasia (BPH)', 'orgStudyIdInfo': {'id': '2008-10-038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transurethral resection of the prostate', 'description': 'TURP group', 'interventionNames': ['Procedure: Transurethral resection of the prostate']}, {'type': 'EXPERIMENTAL', 'label': 'Holmium Laser Enucleation of Prostate', 'description': 'HoLEP group', 'interventionNames': ['Procedure: Holmium Laser Enucleation of the Prostate']}], 'interventions': [{'name': 'Transurethral resection of the prostate', 'type': 'PROCEDURE', 'otherNames': ['TURP'], 'description': 'Standard transurethral resection of the prostate using electrocautery loop', 'armGroupLabels': ['Transurethral resection of the prostate']}, {'name': 'Holmium Laser Enucleation of the Prostate', 'type': 'PROCEDURE', 'description': 'HoLEP using 100W Ho:YAG laser', 'armGroupLabels': ['Holmium Laser Enucleation of Prostate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyu-Sung Lee, Ph.D.,M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Urology, Professor', 'investigatorFullName': 'KYU-SUNG LEE', 'investigatorAffiliation': 'Samsung Medical Center'}}}}