Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT07204002
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Convective Water Vapor Ablation (Convective Water Vapor Energy, WAVE™) With the Rezum™ System Versus Holmium Laser Enucleation of the Prostate (HoLEP) Versus Bipolar Transurethral Resection of the Prostate (TUR-P) in Patients With Benign Prostatic Syndrome (BPS) - A Randomized Study
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 198}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-09-24', 'studyFirstSubmitQcDate': '2025-09-24', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-inferiority of the surgical techniques in symptom improvement, determined by the change (delta) in the International Prostate Symptom Score (IPSS) at 1 month compared to baseline IPSS.', 'timeFrame': '1 month'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['BPH (Benign Prostatic Hyperplasia)', 'HoLEP', 'Rezum', 'TURP(Transurethral Resection of Prostate)']}, 'descriptionModule': {'briefSummary': 'Benign prostatic enlargement (BPH/BPS) is one of the most common benign diseases in adult men. About 50% of men are affected by the age of 50, and between the ages of 70 and 80 the prevalence rises to 70-80%.\n\nThere are various surgical procedures available for the treatment of BPH. In this study, we are investigating three surgical procedures which, based on the current data, appear to be relatively equivalent; however, additional data are still needed to substantiate this.\n\nThe aim of this study is to compare the three surgical methods REZUM vs. HoLEP vs. TUR-P for endoscopic transurethral subvesical de-obstruction with regard to both subjective and objective voiding function, as well as improvements in quality of life and sexual function.\n\nThe goal of the study is to work out the possible advantages and disadvantages for future patient counseling, thereby defining more precisely the role of these surgical procedures within the armamentarium of urology. This is a single-center, randomized, prospective interventional study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Patients with confirmed benign prostatic syndrome for whom surgical therapy is indicated\n* Prostate volume between 30 and 80 ml\n\nExclusion Criteria:\n\nLack of capacity to give informed consent\n\n* Emergency surgeries\n* Known prostate carcinoma\n* Elevated post-void residual urine \\> 300 ml\n* Neurogenic bladder emptying disorder\n* Urethral pathologies\n* High-intensity anticoagulation\n* Dual antiplatelet therapy\n* History of pelvic radiation\n* Chronic pelvic pain syndrome'}, 'identificationModule': {'nctId': 'NCT07204002', 'acronym': 'Vektor', 'briefTitle': 'Comparison of Convective Water Vapor Ablation (Convective Water Vapor Energy, WAVE™) With the Rezum™ System Versus Holmium Laser Enucleation of the Prostate (HoLEP) Versus Bipolar Transurethral Resection of the Prostate (TUR-P) in Patients With Benign Prostatic Syndrome (BPS) - A Randomized Study', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Comparison of Convective Water Vapor Ablation (Convective Water Vapor Energy, WAVE™) With the Rezum™ System Versus Holmium Laser Enucleation of the Prostate (HoLEP) Versus Bipolar Transurethral Resection of the Prostate (TUR-P) in Patients With Benign Prostatic Syndrome (BPS) - A Randomized Study', 'orgStudyIdInfo': {'id': 'EK Nr: 1208/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TURP', 'interventionNames': ['Procedure: Treatment BPH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HOLEP', 'interventionNames': ['Procedure: Treatment BPH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'REZUM', 'interventionNames': ['Procedure: Treatment BPH']}], 'interventions': [{'name': 'Treatment BPH', 'type': 'PROCEDURE', 'description': 'We compare 3 different types of BPH surgery - HoLEP vs. TURP vs. REZUM', 'armGroupLabels': ['HOLEP', 'REZUM', 'TURP']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Conrad Leitsmann, PD Dr.', 'role': 'CONTACT', 'email': 'conrad.leitsmann@medunigraz.at', 'phone': '+43 316 385 81474'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Österreichische Gesellschaft für Urologie', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}