Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
Study NCT ID:
NCT03998150
Status:
COMPLETED
Last Update Posted:
2019-06-27
First Post:
2019-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Holmium Laser vs Bipolar Enucleation of a Large Volume BPH: a Randomised Controlled Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-25', 'studyFirstSubmitDate': '2019-06-14', 'studyFirstSubmitQcDate': '2019-06-24', 'lastUpdatePostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hemoglobin drop postoperatively (gm/dL)', 'timeFrame': 'Immediate postoperatively', 'description': 'difference in hemoglobin concentration postoperatively vs preoperatively'}, {'measure': 'operative time', 'timeFrame': 'during surgery', 'description': 'operative time in minutes'}], 'secondaryOutcomes': [{'measure': 'complications (%)', 'timeFrame': 'one year', 'description': 'intraoperative and postoperative complications including blood transfusion, capsular perforation, irritative symptoms, SUI, urethral stricture, bladder neck contracture, urinary retention.'}, {'measure': 'urine flow', 'timeFrame': 'one year', 'description': 'Qmax (ml/s),'}, {'measure': 'post-voiding residual urine', 'timeFrame': 'one year', 'description': 'postvoiding residual urine (ml)'}, {'measure': 'International prostate symptom score (IPSS)', 'timeFrame': 'one year', 'description': 'an international commonly used score ranging from 0 - 35 (the worst is 35) evaluating voiding and storage urinary symptoms using 7 questions each one is scored from 0 to 5 according to severity of symptom'}, {'measure': 'Quality of life (QoL) section of International prostate symptom score (IPSS)', 'timeFrame': 'one year', 'description': 'one question scored from 0 up to 6 (6 is worst)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BPH', 'enucleation', 'Prostate', 'LUTS', 'IPSS', 'quality of life', 'Large prostate'], 'conditions': ['BPH With Urinary Obstruction', 'Male']}, 'referencesModule': {'references': [{'pmid': '31813283', 'type': 'DERIVED', 'citation': 'Habib E, Ayman LM, ElSheemy MS, El-Feel AS, Elkhouly A, Nour HH, Badawy MH, Elbaz AG, Roshdy MA. Holmium Laser Enucleation vs Bipolar Plasmakinetic Enucleation of a Large Volume Benign Prostatic Hyperplasia: A Randomized Controlled Trial. J Endourol. 2020 Mar;34(3):330-338. doi: 10.1089/end.2019.0707. Epub 2020 Feb 28.'}]}, 'descriptionModule': {'briefSummary': 'To compare bipolar plasmakinetic enucleation versus holmium laser enucleation for management of large BPH.', 'detailedDescription': 'To compare safety and efficacy of bipolar plasmakinetic enucleation (BPEP) versus holmium laser enucleation (HoLEP) for management of large BPH (\\>80gm).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from LUTS secondary to infravesical obstruction from BPH\n* failed medical treatment\n* International Prostate Symptom Score (IPSS) \\> 13\n* a peak urinary flow rate (Qmax) \\< 15 ml/sec\n* a prostate size ≥ 80 gm\n\nExclusion Criteria:\n\n* presence of a urethral stricture\n* neurological disorder\n* bladder cancer\n* prostate cancer\n* previous history of bladder neck surgery or TURP'}, 'identificationModule': {'nctId': 'NCT03998150', 'acronym': 'BPH', 'briefTitle': 'Holmium Laser vs Bipolar Enucleation of a Large Volume BPH: a Randomised Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Holmium Laser Enucleation Versus Bipolar Plasmakinetic Enucleation of a Large Volume Benign Prostatic Hyperplasia: a Randomised Controlled Study', 'orgStudyIdInfo': {'id': '61647'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HoLEP holmium laser enucleation of the prostate', 'description': 'holmium laser enucleation of the prostate', 'interventionNames': ['Procedure: Holmium laser enucleation of the prostate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BPEP bipolar plasmakinetic enucleation of the prostate', 'description': 'bipolar plasmakinetic enucleation of the prostate', 'interventionNames': ['Procedure: Bipolar plasma kinetic enucleation of the prostate']}], 'interventions': [{'name': 'Holmium laser enucleation of the prostate', 'type': 'PROCEDURE', 'otherNames': ['HoLEP'], 'description': 'cystoscopic transurethral enucleation of the prostate using Holmium laser (Asclepion MultiPulse HoPlus 110W and Lumenis pulse 100W and 120W)', 'armGroupLabels': ['HoLEP holmium laser enucleation of the prostate']}, {'name': 'Bipolar plasma kinetic enucleation of the prostate', 'type': 'PROCEDURE', 'otherNames': ['BPEP'], 'description': 'cystoscopic transurethral enucleation of the prostate using bipolar plasma kinetic energy (KLS Martin Maxium or Covidien Force Triad)', 'armGroupLabels': ['BPEP bipolar plasmakinetic enucleation of the prostate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12222', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'enmar I Habib, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Theodor Bilharz Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Urology', 'investigatorFullName': 'Mohammed Said ElSheemy', 'investigatorAffiliation': 'Cairo University'}}}}