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Steam therapy vs. surgery: can a less invasive fix help men with blocked urine flow?

NCT ID NCT05762198

Disease control Sponsor: Chinese University of Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This trial tests whether a steam-based treatment called Rezūm can work as well as standard surgery (TURP) for men with an enlarged prostate who need a catheter to urinate. Men aged 50 to 80 with this condition will be randomly assigned to receive either Rezūm or TURP. The main goal is to compare symptom improvement after 12 months, and researchers will also track how many men can urinate without a catheter within 3 months and any complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rezūm water vapor thermal therapy (a device that uses steam to shrink prostate tissue) compared with TURP surgery
What this could lead to
If Rezūm works as well as TURP, men with BPH-related urinary retention could avoid surgery and its risks, getting relief with a quicker, less invasive procedure.
What could go wrong
This is a mid-sized trial, and Rezūm may not match TURP's effectiveness for all men. There are risks like infection, bleeding, or the need for a repeat procedure.

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

108 people

The number who actually took part.

Started

May 2023

Finished

Jun 2026

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: * Men 50-80 years * Refractory urinary retention related to benign prostatic hyperplasia (BPH) * On urethral Foley's catheter before treatment * Prostate size 30-80ml on ultrasound Exclusion Criteria: * Prior prostate operation * Past or current history of prostate cancer * Strong suspicion of prostate cancer (e.g. Elevated PSA before urinary retention or abnormal prostate on DRE without workup for prostate cancer) * Known Urethral stricture / Bladder stone / Hypocontractile bladder * Known neurological diseases which may affect bladder function (e.g. Parkinsonism, stroke) * Contraindicated to undergo TURP or REZUM (e.g. not fit for GA/SA, active urinary tract infection, fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped)

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • Prince of Wales Hospital, Chinese University of Hong Kong

    Hong Kong, Hong Kong

More trials for these conditions

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