[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100369024":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":72,"collaborators":24,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":24,"maxAge":24,"enrollmentInfo":84,"targetDuration":24,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":96,"overallStatus":43,"whyStopped":24,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Oslo University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prostate operation","ACTIVE_COMPARATOR","You will have a surgery to remove the prostate gland. The surgery will be done during general anesthesia. If your prostate gland is small the surgery will be done through a catheter into the penis. If your prostate gland is large the surgery will be through an incision in your lower abdomen.",[13],"Procedure: Prostate operation or prostate artery embolization",{"label":15,"type":10,"description":16,"interventionNames":17},"Prostate artery embolization","The embolization is done in the Department of Radiology. There will be placement of a catheter into the artery in one of the groins during local anesthesia. Through this catheter small particles will be injected into the arteries of the prostate gland. When finished, the hole in the artery will be closed.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Prostate operation or prostate artery embolization","As described above.",[15,9],null,[26],{"name":27,"affiliation":28,"role":29},"Nils Einar Kløw, MD, PHD","Department of Radiology, Oslo University Hospital","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Thijs Hagen, MD","CONTACT","+ 47 45002349","thihag@ous-hf.no",{"name":37,"role":33,"phone":38,"phoneExt":24,"email":39},"Eduard Baco, MD, PHD","+47 95221378","eduaba@online.no",[41],{"facility":42,"status":43,"city":44,"state":24,"zip":24,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Oslo University Hospital, Aker","RECRUITING","Oslo","Norway","NO",{"type":48,"coordinates":49},"Point",[50,51],10.74609,59.91273,{"lat":51,"lon":50},[54,56,58,59,62,64,66,68,70],{"name":32,"role":33,"phone":55,"phoneExt":24,"email":35},"+4745002349",{"name":37,"role":33,"phone":57,"phoneExt":24,"email":39},"+4795221378",{"name":27,"role":29,"phone":24,"phoneExt":24,"email":24},{"name":60,"role":61,"phone":24,"phoneExt":24,"email":24},"Ole Jørgen Grøtta, MD, PHD","SUB_INVESTIGATOR",{"name":63,"role":61,"phone":24,"phoneExt":24,"email":24},"Erik Rud, MD, PHD",{"name":65,"role":61,"phone":24,"phoneExt":24,"email":24},"Gunnar Sandbæk, MD, PHD",{"name":67,"role":61,"phone":24,"phoneExt":24,"email":24},"Dag Bay, MD",{"name":69,"role":61,"phone":24,"phoneExt":24,"email":24},"Truls E Bjerklund Johansen, MD, PHD",{"name":71,"role":61,"phone":24,"phoneExt":24,"email":24},"Rolf Eigil Berg, MD, PHD",{"type":29,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Nils-Einar Kløw","Professor","100369024","artery-embolization-vs-operation-of-benign-prostate-hyperplasia-100369024",false,"NCT04084938","Artery Embolization vs Operation of Benign Prostate Hyperplasia","Prostatic Artery Embolization vs Transurethral Resection of the Prostate or Open Prostatectomy in Patients With Symptomatic Benign Prostatic Hyperplasia","NORTAPE","Inclusion Criteria:\n\n* LUTS from Benign Prostate Hyperplasia (BPH) with moderate and severe IPSS score (IPSS \\> 8) and QoL = or \\>3\n* and refractory to medical treatment for at least 6 months or the patient is unwilling to accept medical treatment\n* or BPH using permanent or intermittent catheterization\n* Prostate volume \\> 50 ml\n* Signed informed consent\n\nExclusion Criteria:\n\n* Urological disorders: evidence of clinically significant prostate cancer \\[as defined by START criteria\\] on prostate biopsy (27,28), prostatitis (29,30), detrusor-sphincter dyssynergia or evidence of neurogenic bladder, urethral strictures, bladder neck contracture, bladder stone or bladder cancer\n* Renal insufficiency defined as Glomerular Filtration Rate \\\u003C 30 ml\u002Fmin\u002F1,73m2\n* Known severe reactions to iodine-based contrast or gadolinium-based contrast\n* Previous prostate operation\n* CT examination reveals no access to the prostate arteries.","MALE",{"count":85,"type":86},140,"ESTIMATED","INTERVENTIONAL",[89],"NA","Aim of the study is to compare prostate artery embolization (PAE) to the established surgical treatment for patient acceptance, morbidity, complications, and the functional outcomes. To compare length of stay, hospital costs and time for recovery. 140 patients will be randomized to PAE or surgery. Patients should suffer from lower urinary tract symptoms (LUTS), be candidates for both treatments and willing to undergo both procedures. Before randomization computed tomography angiography of the pelvic arteries is done to select eligible patients. Magnetic resonance imaging of prostate rules out possible cancer. The PAE is done in the angio suite in the radiology department injecting small particles into the prostate arteries. The surgery is done in the operation room in the urology department according to established procedures. Clinical follow-up include clinical visit after 3 months, 1 and 5 years. Acute as well as long term complications will be recorded.",[92,93,94,95],"Benign Prostatic Hyperplasia","Post-Op Complication","Embolization Therapeutic","Transurethral Resection of Prostate Syndrome",[97,98,99,100,101],"Prostate","Embolization","Complication","Operation","Randomization","2023-12-26",{"date":104,"type":105},"2023-12-27","ACTUAL",{"date":107,"type":105},"2019-09-01",{"date":109,"type":86},"2027-12-31",{"name":5,"class":6},1]