Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2026-02-20 @ 8:25 PM
Study NCT ID:
NCT01963312
Status:
COMPLETED
Last Update Posted:
2018-05-07
First Post:
2013-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Efficacy and Safety of the Transarterial Supraselective Embolization of the Prostate to Treat the Urinary Symptoms.
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'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-04', 'studyFirstSubmitDate': '2013-10-11', 'studyFirstSubmitQcDate': '2013-10-11', 'lastUpdatePostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum urinary flow (Qmax)', 'timeFrame': '12 months', 'description': 'Maximum urinary flow (Qmax) measured prior intervention and one year later'}], 'secondaryOutcomes': [{'measure': 'International Prostate Symptom Score (IPSS) measured before and after the intervention', 'timeFrame': '12 months'}, {'measure': 'Reduction in prostate volume', 'timeFrame': '12 months'}, {'measure': 'Sexual function', 'timeFrame': '12 months', 'description': 'Assessed by International Index of Erectile Function (IIEF) prior and and one year after intervention.'}]}, 'conditionsModule': {'conditions': ['Transurethral Resection of Prostate', 'Artery Embolization', 'Benign Prostatic Hyperplasia', 'Lower Urinary Tract Symptoms']}, 'referencesModule': {'references': [{'pmid': '10877424', 'type': 'BACKGROUND', 'citation': 'DeMeritt JS, Elmasri FF, Esposito MP, Rosenberg GS. Relief of benign prostatic hyperplasia-related bladder outlet obstruction after transarterial polyvinyl alcohol prostate embolization. J Vasc Interv Radiol. 2000 Jun;11(6):767-70. doi: 10.1016/s1051-0443(07)61638-8. No abstract available.'}, {'pmid': '19908092', 'type': 'BACKGROUND', 'citation': 'Carnevale FC, Antunes AA, da Motta Leal Filho JM, de Oliveira Cerri LM, Baroni RH, Marcelino AS, Freire GC, Moreira AM, Srougi M, Cerri GG. Prostatic artery embolization as a primary treatment for benign prostatic hyperplasia: preliminary results in two patients. Cardiovasc Intervent Radiol. 2010 Apr;33(2):355-61. doi: 10.1007/s00270-009-9727-z. Epub 2009 Nov 12.'}, {'pmid': '23204546', 'type': 'BACKGROUND', 'citation': 'Pisco J, Campos Pinheiro L, Bilhim T, Duarte M, Rio Tinto H, Fernandes L, Vaz Santos V, Oliveira AG. Prostatic arterial embolization for benign prostatic hyperplasia: short- and intermediate-term results. Radiology. 2013 Feb;266(2):668-77. doi: 10.1148/radiol.12111601. Epub 2012 Nov 30.'}, {'pmid': '18309010', 'type': 'BACKGROUND', 'citation': 'Mauro MA. Can hyperplastic prostate follow uterine fibroids and be managed with transcatheter arterial embolization? Radiology. 2008 Mar;246(3):657-8. doi: 10.1148/radiol.2463071721.'}], 'seeAlsoLinks': [{'url': 'http://www.navarrabiomed.es', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the transarterial supraselective embolization (TSE) is a technique as effective as transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of benign prostatic hyperplasia with moderate or severe obstructive lower urinary tract symptoms\n* Refractory to medical treatment for at least 6 months\n* Qmax (maximum urinary flow) less than 10 mL/second\n\nExclusion Criteria:\n\n* Patients not candidates for transurethral resection of the prostate (TURP)\n* Advanced atherosclerosis and tortuosity of the iliac arteries\n* No visualization of the prostatic artery CT angiography study\n* Urethral stenosis, detrusor failure or neurogenic bladder\n* Glomerular filtration \\< 30 mL/min\n* Presence of malignant tumor\n* History of allergy to iodinated contrast\n* Patients with any other medical or social condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results"}, 'identificationModule': {'nctId': 'NCT01963312', 'briefTitle': 'Clinical Trial to Evaluate the Efficacy and Safety of the Transarterial Supraselective Embolization of the Prostate to Treat the Urinary Symptoms.', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Miguel Servet'}, 'officialTitle': 'A Randomised Clinical Trial to Compare Efficacy and Safety of the Transarterial Supraselective Embolization of the Prostate Compared Versus the Transurethral Resection of the Prostate to Treat the Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia.', 'orgStudyIdInfo': {'id': 'FMSECUR-11'}, 'secondaryIdInfos': [{'id': '2011-002108-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transarterial Supraselective Embolization', 'description': 'Transarterial supraselective embolization of prostatic arteria with Bead Block 300-500 μm', 'interventionNames': ['Procedure: Transarterial Supraselective Embolization of the prostate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transurethral Resection', 'description': 'Surgery to remove part of the prostate gland', 'interventionNames': ['Procedure: Transurethral Resection of the prostate']}], 'interventions': [{'name': 'Transarterial Supraselective Embolization of the prostate', 'type': 'PROCEDURE', 'armGroupLabels': ['Transarterial Supraselective Embolization']}, {'name': 'Transurethral Resection of the prostate', 'type': 'PROCEDURE', 'armGroupLabels': ['Transurethral Resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}], 'overallOfficials': [{'name': 'Saturnino Napal, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Complejo Hospitalario de Navarra'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Miguel Servet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}