RecruitingNot ApplicableNCT07759752

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

Sponsor

The University of Hong Kong

Enrollment

150 participants

Start Date

Aug 6, 2026

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Sex: MALEMin Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Prolieve Transurethral Thermodilatation System and a medical device called UroLift Prostatic Urethral Lift System for people with bph (benign prostatic hyperplasia) and luts(lower urinary tract symptoms). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEProlieve 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.

DEVICEUroLift 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.