Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-26 @ 6:13 PM
Study NCT ID:
NCT03583034
Status:
UNKNOWN
Last Update Posted:
2018-07-12
First Post:
2018-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes and Complications of Holmium Laser Enucleation of the Prostate in Expert Hands
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 275}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2020-06-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-11', 'studyFirstSubmitDate': '2018-06-18', 'studyFirstSubmitQcDate': '2018-06-27', 'lastUpdatePostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional outcomes as assessed with IPSS questionnaire', 'timeFrame': '12 months', 'description': 'functional urinary outcomes will be assessed with IPSS questionnaire at different time points over the first year after surgery.'}], 'secondaryOutcomes': [{'measure': 'Identification of clinical characteristics associated with risk of post-operative complications (recorded according to the Clavien-Dindo classification)', 'timeFrame': '12 months', 'description': 'The association between clinical characteristics (e.g. age, BMI, comorbidities, prostate volume) and the risk of post-operative complications will be assessed'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HoLEP', 'Prostate'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '37069007', 'type': 'DERIVED', 'citation': 'Capogrosso P, Ventimiglia E, Fallara G, Schifano N, Costa A, Candela L, Pellegrino F, Colandrea G, Cignoli D, De Angelis M, Belladelli F, Longoni M, Avesani G, Lanzaro F, Scattoni V, Deho F, Salonia A, Briganti A, Montorsi F. Holmium Laser Enucleation of the Prostate Is Associated with Complications and Sequelae Even in the Hands of an Experienced Surgeon Following Completion of the Learning Curve. Eur Urol Focus. 2023 Sep;9(5):813-821. doi: 10.1016/j.euf.2023.03.018. Epub 2023 Apr 15.'}]}, 'descriptionModule': {'briefSummary': 'The efficacy and safety of holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) have been comprehensively assessed. However, HoLEP is considered as a challenging procedure with a steep learning curve. As such, HoLEP is not as yet considered the gold standard for the surgical treatment of LUTS/BPH by international clinical guidelines.\n\nThe investigators aim to assess the complications and outcomes of patients treated with HoLEP by high volume surgeons, in order to provide data on the safety of the procedure and identify the profile of patients who may benefit from a dedicated clinical management to reduce the risk of post-operative complications.', 'detailedDescription': "This is a prospective case-series study collecting data of patients treated with HoLEP at a single academic center. Patients submitted to surgery for bladder outlet obstruction (BOO) due to BPH will be consecutively included. All surgeries will be performed by two experienced surgeons with more than 1000 procedures performed (FM; GB).\n\nPatients with neurological diseases and those with a history of previous surgery of the lower urinary tract (e.g. urethra and prostate surgery) will be excluded.\n\nAt the time of primary screening, all patients will be assessed with a comprehensive medical history; other pre-operative data will include: prostate volume (as assessed with trans-rectal prostate ultrasound); uroflowmetry parameters; total Prostate specific Antigen (PSA); baseline haemoglobin and creatinine level. Moreover, all patients will be invited to fill psychometric validated questionnaires assessing pre-operative urinary and sexual function, thus including: the International Prostatic Symptoms Score (IPSS); the International Index of Erectile Function (IIEF); the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF); and the Overactive Bladder Questionnaire (OABq). Moreover, urinary continence (UC) will be further assessed with a single question, and UC defined as no-pad use. Patients' medications will be also recorded.\n\nIntra-operative data will be collected at the time of surgery, including: patients' systolic blood pressure; laser settings; enucleation efficiency (weight of enucleated tissue divided by lasing time) and morcellation efficiency (weight of enucleated tissue divided by morcellation time). Moreover, surgeons will be requested to provide a subjective estimation of the difficulty of the procedure with a 10-point Likert scale.\n\nPost-operative data including: length of stay; timing of catheter removal and complications, will be also collected.\n\nAll patients will be re-assessed at 1 week after surgery to check for UC. Subjective symptoms, as assessed with validated questionnaires (IPSS; IIEF, ICIQ-SF; OABq), along with post-operative complications and medications used, will be firstly assessed at 1 month after surgery. All patients will undergo a first uroflowmetry evaluation at 3 months after surgery; at this time-point data on blood tests (total PSA, haemoglobin and creatinine), urine culture and symptoms scores will be collected.\n\nA final assessment will be performed at 1 year after surgery including: blood tests, uroflowmetry, IPSS, IIEF, ICIQ-SF, OABq and complications.\n\nOver the follow-up period, the prevalence of patients needing medications for disturbing symptoms will be recorded; moreover, pelvic floor training (PFT) will be suggested to each patient reporting pad-use for urinary incontinence."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients submitted to surgery for bladder outlet obstruction (BOO) due to BPH', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with lower urinary tract symptoms due to benign prostatic hyperplasia\n\nExclusion Criteria:\n\n* neurological diseases; previous surgery on the lower urinary tract (urethra/prostate)'}, 'identificationModule': {'nctId': 'NCT03583034', 'acronym': 'ExpHo', 'briefTitle': 'Outcomes and Complications of Holmium Laser Enucleation of the Prostate in Expert Hands', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Prospective Assessment of Outcomes and Complications of Patients Submitted to Holmium Laser Enucleation of the Prostate (HoLEP) in a High Volume Center', 'orgStudyIdInfo': {'id': 'ExpHo study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Holmium laser enucleation of the prostate (HoLEP)', 'type': 'PROCEDURE', 'description': 'Surgery for benign prostatic hyperplasia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'MI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Capogrosso, MD', 'role': 'CONTACT', 'email': 'paolo.capogrosso@gmail.com', 'phone': '+390226437286'}], 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Paolo Capogrosso, MD', 'role': 'CONTACT', 'email': 'capogrosso.paolo@hsr.it', 'phone': '+390226437286'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman Department of Urology IRCCS San Raffaele Hospital Professor of Urology Vita Salute San Raffaele University', 'investigatorFullName': 'Francesco Montorsi', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}