Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-30 @ 8:45 PM
Study NCT ID:
NCT04342533
Status:
UNKNOWN
Last Update Posted:
2021-07-22
First Post:
2020-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Randomized Trial of Irritative Symptoms Severity Assessment After (HoLEP) Versus ThuFLEP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-21', 'studyFirstSubmitDate': '2020-03-12', 'studyFirstSubmitQcDate': '2020-04-08', 'lastUpdatePostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'severity of urinary incontinence', 'timeFrame': 'change from 1 week to 6 months after surgery', 'description': 'Questionnaire for Urinary Incontinence Diagnosis (higher score means worse incontinence)'}], 'secondaryOutcomes': [{'measure': 'rate of intra- and perioperative adverse events', 'timeFrame': '6 months follow up', 'description': 'complications according to Clavien-Dindo classification (higher score means more severe complication)'}, {'measure': 'surgery duration', 'timeFrame': 'during surgery', 'description': 'lengths of the procedure'}, {'measure': 'hemoglobin drop', 'timeFrame': '1 day after surgery', 'description': 'decrease of hemoglobin at the first day after surgery comparing to preoperative value'}, {'measure': 'catheter stay', 'timeFrame': '1 week after surgery', 'description': 'lengths of catheterization'}, {'measure': 'hospitalization length', 'timeFrame': '1 week after surgery', 'description': 'duration of staying at hospital after the surgery'}, {'measure': 'functional outcomes', 'timeFrame': 'change from 3 to 6 months after surgery', 'description': 'IPSS (international prostate symptos score), QoL (quality of life), IIEF-5 (international index of erectile function) questionaries, Qmax'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HoLEP', 'ThuFLEP', 'EEP', 'prostate enucleation'], 'conditions': ['BPH', 'Prostate Obstruction']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that the functional outcomes of both techniques are comparable. However, ThuFLEP might increase speed recovery of postoperative irritation and early stress urinary incontinence according to the Questionnaire for Urinary Incontinence Diagnosis (QUID) because of minimal tissue penetration depth of TFL.', 'detailedDescription': 'Thulium fiber laser enucleation of the prostate (ThuFLEP) has already shown the outcomes comparable to OSP with better safety profile (lower blood loss compared to OSP) and shorter hospital stay. TFL has the efficacy and safety proven in comparative trials, being a promising rival for HoLEP. The main features of TFL distinguishing it from Ho:YAG is its wavelength of 1.94 µm (leading to about three-fold increase in water absorption and lesser penetration depth of \\<0.1 mm vs \\>0.2 mm in Ho:YAG). With identical average and peak powers of 100 W, the laser does not burst tissues, allowing for clean and precise cutting instead. Conversely, Ho:YAG\'s average power is about 100 W and its presumable peak power is around 10-15 kW. With such an outburst of energy, each pulse of Ho:YAG creates a large vapor bubble which ruptures the tissue. This may be a possible reason for increased irritative symptoms in early postoperative period after HoLEP comparing to ThuFLEP. But all in all, the probable causes for such postoperative symptoms remain unclear so far, despite the fact that absence of irritation and incontinence is ought to be one quality marker of "Pentafecta". According to the idea of high-power impact, probably, decreasing of HoLEP power will mitigate these problems. On the one hand, low-power HoLEP is feasible, safe and effective modality for symptomatic BPO. However, the results remain controversial and there is lack of LP-HoLEP application data nowadays. May be, with another option, for instance OSP or monopolar enucleation, it is possible to solve the issues. But the discussion of the past years demonstrates that the presence of early SUI is not only a problem of EEP, but also underreported in other approaches in relieving BPO secondary to BPH.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'presence of prostate and BPH', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* LUTS presence, proven by:\n\n 1. IPSS questionnaire (Score \\>20);\n 2. 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': 'NCT04342533', 'acronym': 'PRISSA', 'briefTitle': 'Prospective Randomized Trial of Irritative Symptoms Severity Assessment After (HoLEP) Versus ThuFLEP', 'organization': {'class': 'OTHER', 'fullName': 'I.M. Sechenov First Moscow State Medical University'}, 'officialTitle': 'Prospective Randomized Trial of Irritative Symptoms Severity Assessment After Holmium Laser Enucleation of the Prostate (HoLEP) Versus Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP).', 'orgStudyIdInfo': {'id': 'Sechenov-Ho_Vs_TFL-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ThuFLEP', 'description': 'Patients who underwent thulium fiber enucleation of the prostate', 'interventionNames': ['Procedure: Thulium fiber laser enucleation of the prostate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HoLEP', 'description': 'Patients who underwent holmium laser enucleation of the prostate', 'interventionNames': ['Procedure: Holmium laser enucleation of the prostate']}], 'interventions': [{'name': 'Thulium fiber laser enucleation of the prostate', 'type': 'PROCEDURE', 'otherNames': ['ThuFLEP'], 'description': 'enucleation of the BPH according to standard procedure protocol', 'armGroupLabels': ['ThuFLEP']}, {'name': 'Holmium laser enucleation of the prostate', 'type': 'PROCEDURE', 'otherNames': ['HoLEP'], 'description': 'enucleation of the BPH according to standard procedure protocol', 'armGroupLabels': ['HoLEP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119991', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Institute for Urology and Reproductive Health, Sechenov University.', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'I.M. Sechenov First Moscow State Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy director for research', 'investigatorFullName': 'Dmitry Enikeev, MD, PhD', 'investigatorAffiliation': 'I.M. Sechenov First Moscow State Medical University'}}}}