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NCT07759752

Transurethral Thermodilatation vs. Prostatic Urethral Lift for Moderate-to-Severe BPH

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

Summary

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. The main questions are: 1. Is Prolieve non-inferior to UroLift in improving IPSS symptom scores at 3 months? 2. Does Prolieve cause less pain and avoid the need for injected anaesthesia? Researchers 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. Participants 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.

Official title: Transurethral Thermodilatation Versus Prostatic Urethral Lift for Moderate-to-Severe BPH: A Randomised Controlled Non-Inferiority Trial

Key Details

Gender

MALE

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-08-06

Completion Date

2029-11-05

Last Updated

2026-08-12

Healthy Volunteers

Conditions

BPH (Benign Prostatic Hyperplasia)LUTS(Lower Urinary Tract Symptoms)

Interventions

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.

DEVICE

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.

Inclusion Criteria: Participants must satisfy ALL of the following: * Male, aged ≥ 50 and ≤ 80 years * Moderate-to-severe LUTS due to BPH: IPSS total score ≥ 13 at screening * Peak urinary flow rate (Qmax) ≥ 5 and ≤ 12 mL/s with minimum voided volume ≥ 125 mL on free uroflowmetry. The lower Qmax bound of ≥ 5 mL/s excludes near-complete retention with likely detrusor underactivity, as adopted in the Rezūm pivotal trial * Prostate volume 30-80 g by transrectal ultrasound (TRUS) or multiparametric MRI, consistent with the L.I.F.T. and Rezūm pivotal study ranges * Post-void residual (PVR) ≤ 250 mL by bladder ultrasound * Currently on, or has previously tried, medical therapy for BPH (alpha-blocker and/or 5-alpha-reductase inhibitor) for ≥ 4 weeks with inadequate symptom control, or documented intolerance to medical therapy * Able to provide written informed consent * Able and willing to attend all study follow-up visits Exclusion Criteria: Participants will be excluded if ANY of the following apply: * Intravesical prostatic protrusion \> 10 mm on TRUS. * Presence of metallic pelvic implants, penile prosthesis, femoral metallic implant, cardiac pacemaker, or implantable cardioverter-defibrillator. * Previous transurethral resection of the prostate (TURP), HoLEP, or any prior endoscopic prostate surgery. * Prior pelvic radiation therapy. * Prostatic urethral length \< 1.2 cm or \> 5.5 cm. * Confirmed or suspected prostate carcinoma (unresolved elevated PSA without negative biopsy, or any known malignancy). * Active urinary tract infection at screening. * Bladder stone, bladder tumour, or suspected bladder malignancy. * Urethral stricture or bladder neck contracture precluding catheter passage (Foley ≥ 18 Fr). * Neurogenic bladder or known clinically significant detrusor underactivity. * History of acute urinary retention. * Coagulopathy or therapeutic anticoagulation that cannot be bridged perioperatively. * Renal impairment: eGFR \< 30 mL/min/1.73 m² (Cockcroft-Gault). * Desire to preserve fertility (due to risk of retrograde ejaculation with either device). * IPSS QoL bother score \< 3 (patient not sufficiently bothered to warrant procedural intervention). * Participation in another interventional clinical trial within the preceding 30 days.

Locations (1)

Queen Mary Hospital

Hong Kong, Hong Kong