Transurethral Thermodilatation vs. Prostatic Urethral Lift for Moderate-to-Severe BPH (NCT07759752) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Transurethral Thermodilatation vs. Prostatic Urethral Lift for Moderate-to-Severe BPH
Hong Kong150 participantsStarted 2026-08-06
Plain-language 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.
Who can participate
Age range
50 Years – 80 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 bio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in International Prostate Symptom Score (IPSS) at 3 Months