[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492006":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":39,"locations":46,"responsibleParty":89,"collaborators":93,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":44,"enrollmentInfo":106,"targetDuration":44,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":48,"whyStopped":44,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TUMT","EXPERIMENTAL","In this arm, patients will undergo Transurethral Microwave Thermotherapy (TUMT) where microwave energy is used to destroy the prostate tissue. TUMT is performed under local anaesthesia. Usually, the patient can be discharged from the hospital on the same day. If the patient cannot be discharged on the same day, he will be admitted to the urological ward. After the treatment, a transurethral catheter is inserted. This will be removed at the physician's discretion when spontaneous voiding is achieved with an acceptable residual volume (in general \\\u003C100-150 ml), typically within four weeks.",[13],"Procedure: Transurethral Microwave Thermotherapy",{"label":15,"type":10,"description":16,"interventionNames":17},"PAE","In this arm, patients will undergo prostate artery embolisation (PAE) where blocking the blood flow to the prostate causes it to shrink. PAE is performed under local anaesthesia. Usually, the patient can be discharged from the hospital on the same day. If the patient cannot be discharged on the same day, he will be admitted to the urological ward. Patients with a permanent catheter prior to PAE will keep the catheter up to four weeks after the procedure.",[18],"Procedure: Prostate Artery Embolisation",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Transurethral Microwave Thermotherapy","TUMT is performed by a urologist and\u002For a trained urological nurse. In TUMT a specially designed instrument that sends out microwave energy is inserted inside the prostate through the urethra. Cooling fluid circulates the instrument to prevent heat from damaging the wall of the urethra. To prevent the temperature from getting too high outside the prostate a temperature sensor is inserted into the patient's rectum and at the penoscrotal angle. If the temperature reaches the safety limit the microwave generator's output will be shut off automatically. Microwave is then used to heat the prostate (preferably to 50-60 degrees Celsius) and destroy hyperplastic prostate tissue. As the prostate heals it will shrink and reduce the blockage of urine flow and the symptoms of BPH.",[9],[9],{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Prostate Artery Embolisation","In PAE an interventional radiologist will insert a small catheter into the vessels that supply blood to the prostate. An arteriogram is done to map the blood vessels feeding the prostate. Tiny embolization particles are injected through the catheter and into the blood vessels to reduce the blood supply to the prostate. This procedure is intended bilaterally at both sides of the prostate. Following the procedure, the prostate will begin to shrink reducing the symptoms of BPH.",[15],[15],[32,36],{"name":33,"affiliation":34,"role":35},"Andreas Røder, Prof.,MD,PhD","Urological Research Unit, Rigshospitalet","STUDY_DIRECTOR",{"name":37,"affiliation":38,"role":35},"Mikkel M Fode, Prof.,MD,PhD","Department of Urology, Herlev-Gentofte Hospital",[40],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Anna Kristensen-Alvarez, MD","CONTACT","+4535456152",null,"anna.kristensen-alvarez@regionh.dk",[47,64,78],{"facility":34,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Copenhagen","Copenhagen N","2200","Denmark","DK",{"type":55,"coordinates":56},"Point",[57,58],12.56553,55.67594,{"lat":58,"lon":57},[61,62],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},{"name":33,"role":42,"phone":43,"phoneExt":44,"email":63},"andreas.roeder@regionh.dk",{"facility":38,"status":48,"city":65,"state":66,"zip":67,"country":52,"countryCode":53,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Gentofte Municipality","Hellerup","2900",{"type":55,"coordinates":69},[70,71],12.54601,55.74903,{"lat":71,"lon":70},[74,75],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},{"name":37,"role":42,"phone":76,"phoneExt":44,"email":77},"+4538680140","mikkel.mejlgaard.fode@regionh.dk",{"facility":79,"status":48,"city":80,"state":44,"zip":81,"country":52,"countryCode":53,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Zealand University Hospital","Roskilde","4000",{"type":55,"coordinates":83},[84,85],12.08035,55.64152,{"lat":85,"lon":84},[88],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},{"type":90,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"PRINCIPAL_INVESTIGATOR","Anna Kristensen-Alvarez","Principal Investigator",[94],{"name":95,"class":6},"Herlev and Gentofte Hospital","100492006","clinical-trial-on-the-effectiveness-of-tumt-compared-to-pae-in-reducing-severe-luts-in-men-with-bph-100492006",false,"NCT05686525","Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men with BPH","Non-inferiority, Randomised, Open-label Clinical Trial on the Effectiveness of Transurethral Microwave Thermotherapy Compared to Prostatic Artery Embolisation in Reducing Severe Lower Urinary Tract Symptoms in Men with Benign Prostatic Hyperplasia","TUMT-PAE-1","Inclusion Criteria:\n\n* Ability to understand and the willingness to sign an informed consent.\n* Diagnosis of LUTS secondary to BPH refractory to\u002Fcontraindicated for medical treatment or not patient preference.\n* Severe urinary symptoms on IPSS (IPSS score ≥ 20).\n* Bladder outlet obstruction (BOO) is defined by Qmax ≤ 15ml\u002Fsec, based on uroflowmetry.\n* Prostate volume at minimum 50 ml measured by TRUS or MR.\n* Men with prostate cancer in Active Surveillance or Watchful Waiting who have LUTS due to a large BPH component are allowed.\n* Indwelling catheter or intermittent catheter is allowed. In this case baseline IPSS is 35 points.\n\nExclusion Criteria:\n\n* Active bladder cancer (patients with pTa low-grade tumors are allowed).\n* Previous pelvic radiation for cancer treatment.\n* Bladder stones (inclusion is allowed after removal).\n* Current urethral strictures or bladder neck contracture.\n* Neurogenic LUTS.\n* Symptomatic urinary tract infection at the time of intervention.\n* Documented bacterial prostatitis in the last year.\n* Severe atheromatous disease or other pathology preventing catheter-based intervention (as rated on CT angiography by an interventional radiologist).\n* Allergy to iodinated contrast media.\n* Renal failure defined as estimated glomerular filtration rate (eGFR) \\\u003C 35ml\u002Fmin.\n* High bleeding risk (spontaneous international normalized ratio (INR) \\> 1.6).\n* Contraindication to conscious sedation (if requested by the patient).\n* Prostate median lobe defined by treating physician.\n* Urethral colliculus to bladder neck length \\\u003C35mm.","MALE","40 Years",{"count":107,"type":108},220,"ESTIMATED","INTERVENTIONAL",[111],"NA","The TUMT-PAE-1 trial is a randomised clinical trial aiming to compare the effectiveness of transurethral microwave thermotherapy (TUMT) with prostatic artery embolisation (PAE) in reducing urinary symptoms caused by prostate gland enlargement. The assessment will be done by patient reported and functional outcome measures. The primary purpose is to evaluate the urinary symptoms six months after the procedure, measured by the International Prostate Symptom Score (IPSS).",[114,115],"Prostatic Hyperplasia","Lower Urinary Tract Symptoms",[117,118,22,119],"Embolization, Therapeutic","Prostatic Artery Embolization","Patient Reported Outcome Measures","2025-01-10",{"date":122,"type":123},"2025-01-13","ACTUAL",{"date":125,"type":123},"2022-10-27",{"date":127,"type":108},"2030-12",{"name":5,"class":6},3]