Transurethral Thermodilatation vs. Prostatic Urethral Lift for Moderate-to-Severe BPH
Trial statusNot yet recruiting
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
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
Treatments tested in this trial
- Prolieve Transurethral Thermodilatation System
- UroLift Prostatic Urethral Lift System
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov