Transurethral Thermodilatation vs Prostatic Urethral Lift for BPH in men 50–80

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized comparison evaluates two minimally invasive procedures for moderate-to-severe BPH with LUTS. Participants stop their BPH medications briefly and undergo either Prolieve thermodilatation or UroLift on the same day, followed by follow-up visits at 1, 3, 6, and 12 months to measure symptom scores, urine flow, and bladder status. The primary aim is to determine non-inferiority of Prolieve to UroLift in improving IPSS at 3 months, with secondary attention to pain and need for injections. The trial is conducted at Queen Mary Hospital in Hong Kong under The University of Hong Kong as lead sponsor.

Why it matters

Who can join: the full rules

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.

Where it's running

• Queen Mary Hospital
  Hong Kong, Hong Kong Recruiting

Study contacts

• Principal investigator: Shung Lai John Leung, MBBS, FRCSEd, FCSHK, FHKAM — The University of Hong Kong, Hospital Authority
• Study coordinator: Shung Lai John Leung, MBBS, FRCSEd, FCSHK, FHKAM
• Email: jslleung@hku.hk
• Phone: +852 2255 4310

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.