Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-01-04 @ 9:57 PM
Study NCT ID:
NCT06839768
Status:
RECRUITING
Last Update Posted:
2025-02-21
First Post:
2025-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of MILEP Versus Standard EEP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}], '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'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 340}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2025-02-17', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of SUI', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Rate of urethral strictures', 'timeFrame': '6-12 months'}, {'measure': 'Rate of intra- and perioperative adverse events', 'timeFrame': 'the day of operation, at 1, 6,12 months post-operative', 'description': 'Assessed using Clavien-Dindo classification system'}, {'measure': 'Operative time', 'timeFrame': 'participants will be followed for the duration of the intervention, an expected average of 1 hour'}, {'measure': 'Blood loss (blood levels of haemoglobin and haematocrit)', 'timeFrame': '1 day before and 1 day after surgery'}, {'measure': 'Catheterization time', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 1,5 days'}, {'measure': 'Hospital stay', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 1,5 days'}, {'measure': 'International Prostate Symptom Score (IPSS)', 'timeFrame': '1 month', 'description': 'Mild LUTS (symptom score less than of equal to 7) Moderate LUTS (symptom score range 8-19) Severe LUTS (symptom score range 20-35)'}, {'measure': 'Qmax', 'timeFrame': '1 month'}, {'measure': 'PVR', 'timeFrame': '1 month'}, {'measure': 'International Index of Erectile Function (IIEF-5)', 'timeFrame': '1 month', 'description': 'severe ED (5-7), moderate ED (8-11), mild to moderate ED (12-16), mild ED (17-21), and no ED (22-25)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Benign Prostate Hypertrophy(BPH)', 'LUTS(Lower Urinary Tract Symptoms)']}, 'descriptionModule': {'briefSummary': 'Endoscopic enucleation of the prostate (EEP) is a standard treatment for benign prostatic hyperplasia (BPH), with modifications such as MiLEP that utilizes smaller instruments. The reduced resectoscope diameter in MiLEP may help decrease rates of stress urinary incontinence (SUI) and urethral strictures.\n\nObjective: to compare the efficacy and safety of MiLEP and standard EEP with a thulium fiber laser (TFL).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nLUTS presence, proven by:\n\n1. IPSS questionnaire (Score \\>20);\n2. OR uroflowmetry result (Qmax \\<10 ml/s);\n\nExclusion Criteria:\n\n* Prostate volume \\> 120 cc\n* Prostate cancer on pathology;\n* Urethral strictures;\n* Bladder calculi;\n* Prior prostate surgery;\n* Neurogenic bladder dysfunction.'}, 'identificationModule': {'nctId': 'NCT06839768', 'acronym': 'MILES', 'briefTitle': 'Safety and Efficacy of MILEP Versus Standard EEP', 'organization': {'class': 'OTHER', 'fullName': 'Sechenov University'}, 'officialTitle': 'The MILES Trial: Prospective Randomized Trial of Safety and Efficacy of Minimally-invasive Versus Standard Laser Enucleation of the Prostate', 'orgStudyIdInfo': {'id': 'MILEP2024_0.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MiLEP (22 Ch)', 'interventionNames': ['Procedure: MiLEP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EEP (26 Ch)', 'interventionNames': ['Procedure: Standard endoscopic enucleation of the prostate (EEP)']}], 'interventions': [{'name': 'Standard endoscopic enucleation of the prostate (EEP)', 'type': 'PROCEDURE', 'description': 'Stabdard EEP will be nerformed using 26 Ch resectoscope. Enucleation will be performed using an en bloc no-touch technique with early apical release.', 'armGroupLabels': ['EEP (26 Ch)']}, {'name': 'MiLEP', 'type': 'PROCEDURE', 'description': 'Minimally-invasive laser EEP will be nerformed using 22 Ch resectoscope. Enucleation will be performed using an en bloc no-touch technique with early apical release.', 'armGroupLabels': ['MiLEP (22 Ch)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119435.', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Vladislav Petov', 'role': 'CONTACT', 'email': 'pettow@mail.ru', 'phone': '+79253517549'}], 'facility': 'Institute for Urology and Reproductive Health, Sechenov University', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Vladislav Petov, Associate Professor, urologist', 'role': 'CONTACT', 'email': 'pettow@mail.ru', 'phone': '+7 925 351 75 49'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sechenov University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Pompeia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assosiate Professor, urologist', 'investigatorFullName': 'Vladislav Petov', 'investigatorAffiliation': 'Sechenov University'}}}}