Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-12 @ 10:32 PM
Study NCT ID:
NCT04935151
Status:
COMPLETED
Last Update Posted:
2021-06-24
First Post:
2021-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HoLEP vs BPRP in the Management of a Large Volume (> 80 gm) Symptomatic BPH
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': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-21', 'studyFirstSubmitDate': '2021-06-06', 'studyFirstSubmitQcDate': '2021-06-21', 'lastUpdatePostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'complications (percent)', 'timeFrame': 'Three years', 'description': 'All complications'}, {'measure': 'International prostate symptom score (IPSS)', 'timeFrame': 'Three years', '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)', 'timeFrame': 'Three years', 'description': 'section of International prostate symptom score (IPSS) one question scored from 0 up to 6 (6 is worst)'}, {'measure': 'flowmetry', 'timeFrame': 'Three years', 'description': 'rate of flow (ml urine) per second'}], 'primaryOutcomes': [{'measure': 'hemoglobin drop postoperatively (gm/dL)', 'timeFrame': 'within two hours after surgery', 'description': 'change in hemoglobin concentration postoperatively vs preoperatively'}], 'secondaryOutcomes': [{'measure': 'operative duration in minutes', 'timeFrame': 'Time lapsed during surgery', 'description': 'operative duration'}, {'measure': 'Hospital stay', 'timeFrame': 'From time of randomisation up to last day of admission in hospital (in days) up to 30 days', 'description': 'Hospitalisation starting from day of surgery till the day of discharge from Hospital in days'}, {'measure': 'blood transfusion', 'timeFrame': 'during surgery and hospitalisation up to 10 days', 'description': 'rate of blood transfusion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BPH', 'enucleation', 'Large Prostate', 'LUTS', 'IPSS', 'quality of life'], 'conditions': ['BPH With Urinary Obstruction', 'Male']}, 'descriptionModule': {'briefSummary': 'To compare bipolar resection versus holmium laser enucleation for management of symptomatic large BPH (\\> 80 gm)', 'detailedDescription': 'To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of symptomatic large BPH (\\> 80 gm)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from LUTS secondary to infravesical obstruction from BPH with 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': 'NCT04935151', 'briefTitle': 'HoLEP vs BPRP in the Management of a Large Volume (> 80 gm) Symptomatic BPH', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Holmium Laser Enucleation Versus Bipolar Resection in the Management of a Large Volume (> 80 gm) Symptomatic BPH: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'REC-TBRI-PT563'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'holmium laser enucleation of the prostate', 'description': 'holmium laser enucleation of the prostate (HoLEP)', 'interventionNames': ['Procedure: holmium laser enucleation of the prostate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bipolar resection of the prostate', 'description': 'bipolar resection of the prostate (BPEP)', 'interventionNames': ['Procedure: Bipolar resection 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', 'armGroupLabels': ['holmium laser enucleation of the prostate']}, {'name': 'Bipolar resection of the prostate', 'type': 'PROCEDURE', 'otherNames': ['BPRP'], 'description': 'cystoscopic transurethral resection of the prostate using bipolar energy', 'armGroupLabels': ['bipolar resection of the prostate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12222', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '12111', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Theodor Bilharz research institute', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Mamdouh A Roshdy, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Theodor Bilharz research institue'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Theodor Bilharz Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mohammed Said ElSheemy', 'investigatorAffiliation': 'Cairo University'}}}}