[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651392":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":41,"locations":50,"responsibleParty":69,"collaborators":45,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":45,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":98,"whyStopped":45,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prolieve Transurethral Thermodilatation","EXPERIMENTAL","Prolieve TUTD involves inserting a treatment catheter under intraurethral lidocaine gel only (no injected anaesthetic or sedation). A 46 French balloon dilates the prostatic urethra while microwave energy (≤50 W) heats periurethral tissue to 41-46°C for 45 minutes, combining mechanical dilatation with thermal ablation. Catheter removed immediately post-procedure; same-day discharge.",[13],"Device: Prolieve Transurethral Thermodilatation System",{"label":15,"type":16,"description":17,"interventionNames":18},"UroLift Prostatic Urethral Lift","ACTIVE_COMPARATOR","UroLift PUL involves cystoscopic deployment of 4-6 permanent nitinol anchors to retract obstructing lateral prostatic lobes, mechanically widening the urethra without tissue ablation. Performed with topical intraurethral lidocaine gel, with or without periprostatic nerve block per site practice. No routine post-procedural catheterisation; same-day discharge.",[19],"Device: UroLift Prostatic Urethral Lift System",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Prolieve Transurethral Thermodilatation System","Prolieve is a minimally invasive, FDA-approved thermotherapy device for BPH. It delivers simultaneous microwave energy (≤50 W) and 46 French balloon dilatation to the prostatic urethra for 45 minutes. It is performed under intraurethral lidocaine gel only-no injected anaesthesia, no sedation, and no operating theatre. Catheter is removed immediately post-procedure; same-day discharge.",[9],[27,28],"Prolieve TUTD","Prolieve System",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"UroLift Prostatic Urethral Lift System","UroLift is a minimally invasive, FDA-cleared device for BPH. It deploys 4-6 permanent nitinol implants under cystoscopic guidance to mechanically retract and hold open the obstructing prostatic lobes, widening the urethra without tissue ablation. Performed with topical intraurethral lidocaine gel, with or without periprostatic nerve block per site practice. No routine post-procedural catheterisation; same-day discharge.",[15],[34,35],"UroLift PUL","UroLift System",[37],{"name":38,"affiliation":39,"role":40},"Shung Lai John Leung, MBBS, FRCSEd, FCSHK, FHKAM","The University of Hong Kong, Hospital Authority","PRINCIPAL_INVESTIGATOR",[42,47],{"name":38,"role":43,"phone":44,"phoneExt":45,"email":46},"CONTACT","+852 2255 4310",null,"jslleung@hku.hk",{"name":48,"role":43,"phone":45,"phoneExt":45,"email":49},"Yusra Saleem, BSc","yusra@hku.hk",[51],{"facility":52,"status":45,"city":53,"state":45,"zip":45,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Queen Mary Hospital","Hong Kong","HK",{"type":56,"coordinates":57},"Point",[58,59],114.17469,22.27832,{"lat":59,"lon":58},[62,63,64,66],{"name":38,"role":43,"phone":44,"phoneExt":45,"email":46},{"name":48,"role":43,"phone":45,"phoneExt":45,"email":49},{"name":65,"role":40,"phone":45,"phoneExt":45,"email":45},"Shung Lai John Leung, MBBS, FRCSEd, FCHK, FHKAM",{"name":67,"role":68,"phone":45,"phoneExt":45,"email":45},"Tsui Lin Ada Ng, MBBS, MPH, FRCSEd, FCHK, FHKAM","SUB_INVESTIGATOR",{"type":40,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"LEUNG SHUNG LAI JOHN","Clinical Assistant Professor","100651392","transurethral-thermodilatation-vs-prostatic-urethral-lift-for-moderate-to-severe-bph-100651392",false,"NCT07759752","Transurethral Thermodilatation vs. Prostatic Urethral Lift for Moderate-to-Severe BPH","Transurethral Thermodilatation Versus Prostatic Urethral Lift for Moderate-to-Severe BPH: A Randomised Controlled Non-Inferiority Trial","THRIVE","Inclusion Criteria:\n\nParticipants must satisfy ALL of the following:\n\n* Male, aged ≥ 50 and ≤ 80 years\n* Moderate-to-severe LUTS due to BPH: IPSS total score ≥ 13 at screening\n* Peak urinary flow rate (Qmax) ≥ 5 and ≤ 12 mL\u002Fs with minimum voided volume ≥ 125 mL on free uroflowmetry. The lower Qmax bound of ≥ 5 mL\u002Fs excludes near-complete retention with likely detrusor underactivity, as adopted in the Rezūm pivotal trial\n* Prostate volume 30-80 g by transrectal ultrasound (TRUS) or multiparametric MRI, consistent with the L.I.F.T. and Rezūm pivotal study ranges\n* Post-void residual (PVR) ≤ 250 mL by bladder ultrasound\n* Currently on, or has previously tried, medical therapy for BPH (alpha-blocker and\u002For 5-alpha-reductase inhibitor) for ≥ 4 weeks with inadequate symptom control, or documented intolerance to medical therapy\n* Able to provide written informed consent\n* Able and willing to attend all study follow-up visits\n\nExclusion Criteria:\n\nParticipants will be excluded if ANY of the following apply:\n\n* Intravesical prostatic protrusion \\> 10 mm on TRUS.\n* Presence of metallic pelvic implants, penile prosthesis, femoral metallic implant, cardiac pacemaker, or implantable cardioverter-defibrillator.\n* Previous transurethral resection of the prostate (TURP), HoLEP, or any prior endoscopic prostate surgery.\n* Prior pelvic radiation therapy.\n* Prostatic urethral length \\\u003C 1.2 cm or \\> 5.5 cm.\n* Confirmed or suspected prostate carcinoma (unresolved elevated PSA without negative biopsy, or any known malignancy).\n* Active urinary tract infection at screening.\n* Bladder stone, bladder tumour, or suspected bladder malignancy.\n* Urethral stricture or bladder neck contracture precluding catheter passage (Foley ≥ 18 Fr).\n* Neurogenic bladder or known clinically significant detrusor underactivity.\n* History of acute urinary retention.\n* Coagulopathy or therapeutic anticoagulation that cannot be bridged perioperatively.\n* Renal impairment: eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² (Cockcroft-Gault).\n* Desire to preserve fertility (due to risk of retrograde ejaculation with either device).\n* IPSS QoL bother score \\\u003C 3 (patient not sufficiently bothered to warrant procedural intervention).\n* Participation in another interventional clinical trial within the preceding 30 days.","MALE","50 Years","80 Years",{"count":84,"type":85},150,"ESTIMATED","INTERVENTIONAL",[88],"NA","This clinical trial aims to determine whether Prolieve® (microwave with balloon dilation) is as effective as UroLift® (prostate implants) for treating moderate-to-severe lower urinary tract symptoms in men aged 50-80 with enlarged prostates (BPH) who have failed oral medications.\n\nThe main questions are:\n\n1. Is Prolieve non-inferior to UroLift in improving IPSS symptom scores at 3 months?\n2. Does Prolieve cause less pain and avoid the need for injected anaesthesia?\n\nResearchers will compare Prolieve (LA urethral gel only, no injections) against UroLift (LA urethral gel with or without local anaesthetic injection) to see if Prolieve offers similar relief with better tolerability.\n\nParticipants will stop their BPH medications for 2-4 weeks, undergo one of the two same-day office procedures, and attend follow-ups at 1, 3, 6, and 12 months for symptom scores, flow tests, and bladder scans.",[91,92],"BPH (Benign Prostatic Hyperplasia)","LUTS(Lower Urinary Tract Symptoms)",[94,95,96,97],"Transurethral Thermodilatation","Prostatic Urethral Lift","BPH","LUTS","NOT_YET_RECRUITING","2026-08-06",{"date":101,"type":102},"2026-08-12","ACTUAL",{"date":99,"type":85},{"date":105,"type":85},"2029-11-05",{"name":5,"class":6},1]