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Can a Needle-Free prostate treatment match implant surgery?

NCT ID NCT07759752

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

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

50 to 80 years

Sex

Male participants only

Healthy volunteers

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

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.

benign prostatic hyperplasia Lower Urinary Tract Symptoms

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Queen Mary Hospital

    RECRUITING

    Hong Kong, Hong Kong

More trials for these conditions

Other studies related to the condition(s) this trial covers.