[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100480073":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":29,"studyPopulation":29,"armGroups":36,"interventions":49,"overallOfficials":58,"centralContacts":63,"locations":73,"responsibleParty":137,"collaborators":140,"id":149,"slug":150,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":29,"eligibilityCriteria":155,"healthyVolunteers":151,"sex":156,"minAge":157,"maxAge":29,"enrollmentInfo":158,"targetDuration":29,"studyType":161,"phases":162,"briefSummary":164,"conditions":165,"keywords":169,"overallStatus":122,"whyStopped":29,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"Uppsala University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":29},[9,13],{"measure":10,"description":11,"timeFrame":12},"Improvement of lower urinary tract symptoms","Assess the change in the lower urinary tract symptoms using the International Prostate Symptom Score (IPSS) questionnaire before and after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)","24 months",{"measure":14,"description":15,"timeFrame":12},"Health care costs","Assess the health care costs after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)",[17,20,23,26],{"measure":18,"description":19,"timeFrame":12},"Adverse effects,","Assess the adverse effects after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)",{"measure":21,"description":22,"timeFrame":12},"Quality of life (Short Form Health Survey [EQ-5D-5L ])","Assess the quality of life after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP). Scored 0-100, where 0 is the lowest and 100 the highest possible quality of life.",{"measure":24,"description":25,"timeFrame":12},"Erectile function","Erectile function using the International Index of Erectile Function (IIEF-5). The possible scores for the IIEF-5 range from 5 to 25, and ED is classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).",{"measure":27,"description":28,"timeFrame":12},"Prostate-Specific Antigen (PSA)","Assess the change in PSA",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":29,"whoMasked":29},"NONE",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"PAE","EXPERIMENTAL","Prostate Artery Embolization (PAE)",[42],"Procedure: Prostate Artery Embolization",{"label":44,"type":45,"description":46,"interventionNames":47},"TURP","ACTIVE_COMPARATOR","Transurethral Prostate Resection (TURP)",[48],"Procedure: Transurethral Prostate Resection (TURP)",[50,55],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":29},"PROCEDURE","Prostate Artery Embolization","Prostate Artery Embolization (PAE) is performed by experienced interventional radiologists. The method involves catheterization of the prostate vessels superselectively with two to three French microcatheters. PAE is performed with microspheres of 250 to 400 µm in size.",[38],{"type":51,"name":46,"description":56,"armGroupLabels":57,"otherNames":29},"Under general\u002Fregional anesthesia, a resectoscope is inserted into the urethra that carries an electric metal loop (monopolar or bipolar diathermy) that is used to cut and extract the prostate tissue.",[44],[59],{"name":60,"affiliation":61,"role":62},"Abbas Chabok","CKF Västerås Uppsala university","PRINCIPAL_INVESTIGATOR",[64,69],{"name":65,"role":66,"phone":67,"phoneExt":29,"email":68},"Emir Majbar, MD","CONTACT","+46-021176939","emir.majbar@regionvastmanland.se",{"name":70,"role":66,"phone":71,"phoneExt":29,"email":72},"Farhood Alamdari, MD, PhD","+46-21173000","farhood.alamdari@regionvastmanland.se",[74,92,106,120],{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Helsingborgs Hospital","NOT_YET_RECRUITING","Helsingborg","Region Skånes","252 23","Sweden","SE",{"type":83,"coordinates":84},"Point",[85,86],12.69437,56.04673,{"lat":86,"lon":85},[89],{"name":90,"role":66,"phone":91,"phoneExt":29,"email":29},"Mats Bläckberg, MD, PhD","+46 424061000",{"facility":93,"status":76,"city":94,"state":95,"zip":96,"country":80,"countryCode":81,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Mälarsjukhuset","Eskilstuna","Region Sörmland","633 49",{"type":83,"coordinates":98},[99,100],16.5077,59.36661,{"lat":100,"lon":99},[103],{"name":104,"role":66,"phone":105,"phoneExt":29,"email":29},"Ninos Oussi, MD, PhD","+46 16103000",{"facility":107,"status":76,"city":108,"state":109,"zip":110,"country":80,"countryCode":81,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Lasarettet i Enköping","Enköping","Region Uppsala","745 38",{"type":83,"coordinates":112},[113,114],17.07768,59.63607,{"lat":114,"lon":113},[117],{"name":118,"role":66,"phone":119,"phoneExt":29,"email":29},"Tammer Hemdan, MD,PhD","+46 17141 80 00",{"facility":121,"status":122,"city":123,"state":124,"zip":125,"country":80,"countryCode":81,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Region Vastmanland Hospital","RECRUITING","Västerås","Västmanland County","721 89",{"type":83,"coordinates":127},[128,129],16.55276,59.61617,{"lat":129,"lon":128},[132,134,135],{"name":65,"role":66,"phone":133,"phoneExt":29,"email":68},"+46 21173000",{"name":70,"role":66,"phone":133,"phoneExt":29,"email":72},{"name":136,"role":62,"phone":29,"phoneExt":29,"email":29},"Abbas Chabok, MD, PhD",{"type":62,"investigatorFullName":138,"investigatorTitle":139,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Abbas Chabok MD","Professor",[141,143,144,146],{"name":142,"class":6},"Centrallasarettet Västerås",{"name":107,"class":6},{"name":145,"class":6},"Sormland County Council, Sweden",{"name":147,"class":148},"Region Stockholm","OTHER_GOV","100480073","transurethral-prostate-resection-turp-vs-prostate-artery-embolization-pae-100480073",false,"NCT05531240","Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE)","Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE): Open Multicentric Randomized Study for Evaluation of Outcomes, Complications, and Health Economics","Inclusion Criteria:\n\n* Benign prostatic hyperplasia where medical treatment has not helped or for other reasons has not been deemed applicable\n* IPSS\\>=12\n* Prostate volume \\[40-100\\] ml measured via transrectal ultrasound\n* Peak flow rate (Qmax) \\\u003C= 15 ml \u002F s,\n* Verified obstruction by urodynamic studies (cystometry)\n* Surgery not contraindicated\n\nExclusion Criteria:\n\n* known prostate or bladder cancer\n* Severe atherosclerosis\n* Kidney failure eGFR \\\u003C 30\n* Urethral stricture\n* Active cystitis or prostatitis\n* Bladder stone.\n* Neurogenic bladder disorder\n* known allergy to iodinated contrast medium","MALE","45 Years",{"count":159,"type":160},104,"ESTIMATED","INTERVENTIONAL",[163],"NA","This study focuses on the treatment of benign prostatic hyperplasia which causes lower urinary tract symptoms.\n\nThe purpose of the research project is to evaluate PAE in terms of both medical and health economic outcomes. To evaluate whether there are any differences in effect (IPSS), complications, costs and perceived quality of life compared with TUR-P.",[166,167,168],"Transurethral Resection of Prostate Syndrome","Prostate Hyperplasia","Embolization, Therapeutic",[170,38],"Prostate embolisation","2026-09-28",{"date":173,"type":174},"2026-10-02","ACTUAL",{"date":176,"type":174},"2022-10-01",{"date":178,"type":160},"2029-12",{"name":5,"class":6},4]