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

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

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexMale

Age50-80

SponsorThe University of Hong Kong

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Prolieve Transurethral Thermodilatation System
Device
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.
UroLift Prostatic Urethral Lift System
Device
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.

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: Prolieve Transurethral ThermodilatationExperimental treatment 1 intervention

Group B: UroLift Prostatic Urethral LiftActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in International Prostate Symptom Score (IPSS) at 3 Months

Mean change in total IPSS score from baseline to 3 months post-procedure. IPSS ranges from 0-35 (higher = worse symptoms); negative change indicates improvement. Non-inferiority margin is 3 points. Analysis uses ANCOVA with treatment arm as fixed effect, adjusted for baseline IPSS, prostate volume stratum (\<40 vs ≥40 g), and baseline IPSS severity stratum (moderate 13-19 vs severe ≥20).

Time frame

Baseline to 3 months post-procedure

Secondary outcomes

Change in IPSS total score at 6 months

Mean change in total International Prostate Symptom Score (IPSS) from baseline to 6 months. IPSS ranges 0-35 (higher = worse symptoms); negative change indicates improvement.

Time frame

Baseline to 6 months post-procedure

Change in IPSS Quality of Life Bother Score

Mean change in IPSS Item 8 (QoL bother score, scale 0-6, higher = more bother) from baseline to 3, 6, and 12 months.

Time frame

Baseline to 3, 6, and 12 months post-procedure

Change in peak urinary flow rate (Qmax)

Mean change in Qmax (mL/s) measured by free uroflowmetry from baseline to 3, 6, and 12 months. Higher values indicate improved flow.

Time frame

Baseline to 3, 6, and 12 months post-procedure

Change in post-void residual volume (PVR)

Mean change in PVR (mL) measured by bladder ultrasound from baseline to 3, 6, and 12 months. Lower values indicate better bladder emptying.

Time frame

Baseline to 3, 6, and 12 months post-procedure

Other outcomes

Cost per responder at 3 months

Exploratory health economic outcome: direct procedural costs plus downstream resource use (GP visits, retreatments, hospitalisations) per patient achieving IPSS reduction ≥5 points at 3 months, expressed in Hong Kong dollars.

Time frame

3 months post-procedure

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov

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