Can a Needle-Free prostate treatment match implant surgery?
NCT ID NCT07759752
First seen Aug 12, 2026 · Last updated Aug 25, 2026 · Updated 3 times
Summary
This trial tests whether a new device called Prolieve, which uses microwave heat and balloon dilation, can relieve moderate-to-severe urinary symptoms from an enlarged prostate as effectively as the established UroLift implant procedure. Men aged 50-80 who haven't found relief from oral medications will be randomly assigned to one of the two same-day office procedures. The study will compare symptom improvement at 3 months and also see if Prolieve causes less pain by avoiding injected anesthesia.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Prolieve Transurethral Thermodilatation System (a device that uses microwave energy and balloon dilation to treat enlarged prostate)
- What this could lead to
- If Prolieve proves as effective as UroLift, it could offer men a needle-free, injection-free, same-day option for relieving bothersome urinary symptoms from an enlarged prostate.
- What could go wrong
- This is a non-inferiority trial, so Prolieve might not match UroLift's effectiveness. It's a single-center study with 150 participants, and results may not apply to all men. As with any procedure, there are risks of discomfort or complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 80 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Queen Mary Hospital
RECRUITINGHong Kong, Hong Kong
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two prostate pills instead of one: can doubling up on alpha blockers clear urine retention?
- Can a gel stop bleeding after prostate surgery and send men home the same day?
- Can a smarter needle angle make prostate relief safer and easier?
- Can sound waves offer a lasting fix for prostate problems?
- Robotic precision could transform prostate surgery
- Can a disposable scope make prostate surgery faster and cheaper?