Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-31 @ 11:48 PM
Study NCT ID:
NCT00890851
Status:
COMPLETED
Last Update Posted:
2009-10-01
First Post:
2009-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Procedure Transurethral Needle Ablation (TUNA) and Hospitalization of Short Duration
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020728', 'term': 'Transurethral Resection of Prostate'}], 'ancestors': [{'id': 'D011468', 'term': 'Prostatectomy'}, {'id': 'D013521', 'term': 'Urologic Surgical Procedures, Male'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-30', 'studyFirstSubmitDate': '2009-04-29', 'studyFirstSubmitQcDate': '2009-04-29', 'lastUpdatePostDateStruct': {'date': '2009-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left the hospital', 'timeFrame': 'the evening of the intervention'}, {'measure': 'Not hospitalized for a complication related to the intervention', 'timeFrame': 'in the month following the intervention'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the satisfaction of the intervention for the patient', 'timeFrame': 'at 1 month'}, {'measure': 'Evaluation for the micturition of the following parameters', 'timeFrame': 'at 1 month'}, {'measure': 'Evaluation of the appeared minor complications', 'timeFrame': 'at 1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Radiofrequency', 'Mini invasin surgery', 'Outpatient treatment', 'Men health'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'The TUNA is a known and already old technique. There exists, in the literature, a certain number of studies showing the long-term effectiveness (5 years), evaluated on the IPS and the flow mictional.This effectiveness is slightly lower than that of the endoscopic resection of prostate. This technique does not present the disadvantages of the surgery prostate sufferer on ejaculation. Moreover, it can be carried out in short hospitalization or ambulatory as it is the case in particular in the States Unis. The aim of the study which will be led by the AP-HP will be thus to test the feasibility of the TUNA during a hospitalization of less 24 hours.', 'detailedDescription': 'The TUNA is a known and already old technique. There exists, in the literature, a certain number of studies showing the long-term effectiveness (5 years), evaluated on the IPS and the flow mictional. This effectiveness is slightly lower than that of the endoscopic resection of prostate. This technique does not present the disadvantages of the surgery prostate sufferer on ejaculation. Moreover, it can be carried out in short hospitalization or ambulatory as it is the case in particular in the States Unis. The aim of the study which will be led by the AP-HP will be thus to test the feasibility of the TUNA during a hospitalization of less the 24h.\n\nObjective one: To test the feasibility of a procedure TUNA at the time of a hospitalization of less 24h.\n\nNumber of patients: A sample of N=70 patients will make it possible to estimate the frequency of success with a precision of ± 10% for any frequency higher than 75%.\n\nAnalyse statistical: Principal analyze: Count held of the aim of the study the principal analyses will be descriptives. For the variables qualitative or semi-quantitative bilateral the confidence frequencies and their interval at 95% (IC95) will be presented. If the conditions of use of the asymptotic estimators would not be filled, of the exact estimators will be used. For the quantitative averages and IC95%, median variables and outdistances interquartile will be calculated. Together analyses will be presented for the general population and by center.\n\nSecondary analyze: In case of rate of important failure, an exploratory analysis at end of identification of the predictive factors of failure will be made by analysis in multivariate logistic regression.\n\nAwaited results: The precise evaluation carried out by the present study will make it possible to evaluate the benefit report/ratio risks in the short run procedure and its feasibility within the framework of a hospitalization in surgery ambulatory. The implications are important. Indeed, if this technique can be done into ambulatory with a high rate of success, then this technique of treatment could be proposed in alternative of the medical treatment or to the bad responders with the medical treatments.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Man whose age is superior or egal to 45 and inferior or egal to 85 years\n2. Patient presenting an anaesthetic risk of ASA 1 at 3\n3. Patient accepting the protocol, in particular the return to residence with a sounder\n4. Patient presenting a TUBA related to a HBP and lasting since more than 3 months\n\n 1. with a gene score higher superior or egal to 3\n 2. with a score IPS superior to 8\n5. Patient presenting a prostate whose estimated weight is inferior or egal to 80g, without median lobe prevailing and whose transverse width lies between 34 and 80 mm.\n6. Patient having a residue post mictional lower than 200cc.\n7. Patient presenting a normal renal function\n8. Patient having a result PSA £ 4 ng/ml, or negative biopsies if PSA \\> 4 and \\< 10 ng/ml\n9. Patient having given his free and in writing lit assent\n10. Patient affiliated to the Social security or an assimilated mode\n11. Patient having stopped his treatment by 5 alpha reductase since at least a month (1)\n\nExclusion Criteria:\n\n1. Patient presenting a urinary infection\n2. Patient presenting an acute retention of urine\n3. Patient presenting a neurological bladder and/or of an anomaly of the sphincter\n4. Patient currently under anticoagulant treatment.\n5. Patient currently under anti-inflammatory treatment.\n6. Patient presenting an affection or a confirmed or suspected malignant tumour of the prostates or vegie.\n7. Patient presenting an antecedent of surgery prostatic\n8. Patient presenting of the biopsies prostate sufferers carried out less than 4 months before procedure TUNA\n9. Patient introducing of the antecedents of vesical lithiasis, haematuria important, contracting of the urethra, stenosis of the vesical collar, pathologies of the bladder or sweetened diabetes affecting vesical operation,\n10. Patient presenting a prosthesis in the zone being able to be affected by the procedure\n11. Patient presenting a desire of fertility\n12. Patient presenting an anorectal pathology\n13. Patient presenting an allergy to the anaesthesia locale\n14. Patient whose follow-up seems incompatible with the needs for the study'}, 'identificationModule': {'nctId': 'NCT00890851', 'acronym': 'EPURE', 'briefTitle': 'Procedure Transurethral Needle Ablation (TUNA) and Hospitalization of Short Duration', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Evaluation of Procedure Tuna Within the Framework of a Hospitalization of Short Duration', 'orgStudyIdInfo': {'id': 'P050302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Procedure TUNA', 'interventionNames': ['Procedure: Transurethral Needle Ablation (TUNA)']}], 'interventions': [{'name': 'Transurethral Needle Ablation (TUNA)', 'type': 'PROCEDURE', 'otherNames': ['radiofrenquency prostate'], 'description': 'Transurethral needle ablation of benign prostatic hyperplasia by radio frequencies', 'armGroupLabels': ['Procedure TUNA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': "Hôpital TENON - Service d'Urologie", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Bertrand LUKACS, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mathieu Quintin', 'oldOrganization': 'Department of clinical research and development'}}}}