Prostate CancerNCT05762198

Comparing Water Vapour Thermal Therapy (Rezūm) and TURP

A study testing Rezūm and TURP in people with Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a randomized controlled trial using a non-inferiority design with the subjects randomized 1:1 to either water vapour thermal treatment (REZUM) arm or transurethral resection of prostate (TURP) arm. Read more about this study

Who is it for?: Ages 50 to 80 years, men only
Conditions the study is for: Prostate Cancer
What is being tested?: Rezūm and TURP
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 1 siteHong Kong
Study dates: 1 May 2023to 30 Jun 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 80 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Prince of Wales Hospital, Chinese University of Hong Kong
Hong Kong

Other trials in Hong Kong

About this study

Official title: A Randomized Controlled Trial Comparing Water Vapour Thermal Therapy (Rezūm) and TURP in Men With Benign Prostatic Hyperplasia in Refractory Urinary Retention

Conditions: Prostate Cancer
Being tested: Rezūm, TURP
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RezūmDevice
In the REZUM arm, water vapour treatment is performed for all subjects under local anaesthesia.
TURPDevice
In the TURP arm, all men will receive TURP operation under general or spinal anaesthesia

Study groups in NCT05762198
Study group	Role	What they receive
Rezūm	Active comparator	Not described Receives: Device: Rezūm
TURP	Active comparator	Not described Receives: Device: TURP

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment
IPSS score ranging from 0-35 (the higher the worse)
Measured: Baseline, 3 months, 6 months and 12 months after intervention

Secondary outcomes (7)

Successful trial without catheter (TWOC) within 3 months
Percentage of patients successfully TWOC
Measured: At 3 months
Complication rate
Assessed by Clavien-Dindo classification
Measured: 30 days after intervention
Post-op quality of life score
Change in quality of life assessed by change in International Prostate QOL score (ranges from 0 to 6, the higher the worse)
Measured: Baseline, 3 months, 6 months and 12 months after intervention
Change in voiding function in uroflowmetry
It is assessed by maximum flow rate and post void volume in uroflowmetry
Measured: Baseline, 3 months, 6 months and 12 months after intervention
Post-op International Index of Erectile function score
Score 1-5 (the lower the worse)
Measured: Baseline, 3 months, 6 months and 12 months after intervention
Hospital stays of procedure
Measure the hours of in-patient hospitalisation
Measured: On Discharge
Unplanned readmission rate after operation in 30 days
Percentage of patients with unplanned readmission
Measured: 30 days after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202330 Jun 2026

First posted9 Mar 2023
Study start1 May 2023
Primary completion30 Jun 2026
Study completion30 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05762198
Sponsor's protocol ID: CRE-2022.537-T
Status last verified: May 2025
First submitted: 28 Feb 2023
Last updated: 8 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ng CF, Yee CH, Chan CK, Wong HM, Chiu PK, Tsu JH, Teoh JY, Ho KL. Bipolar transurethral vapourisation versus monopolar transurethral resection of prostate: a randomised controlled trial. Hong Kong Med J. 2017 Jun;23 Suppl 2(3):32-34. No abstract available.
PubMed 29938669
Yee CH, Wong JH, Chiu PK, Teoh JY, Chan CK, Chan ES, Hou SM, Ng CF. Secondary hemorrhage after bipolar transurethral resection and vaporization of prostate. Urol Ann. 2016 Oct-Dec;8(4):458-463. doi: 10.4103/0974-7796.192110.
PubMed 28057992
Yee CH, Wong JH, Chiu PK, Chan CK, Lee WM, Tsu JH, Teoh JY, Ng CF. Short-stay transurethral prostate surgery: A randomized controlled trial comparing transurethral resection in saline bipolar transurethral vaporization of the prostate with monopolar transurethral resection. Asian J Endosc Surg. 2015 Aug;8(3):316-22. doi: 10.1111/ases.12197. Epub 2015 Jun 3.
PubMed 26042336
Yip SK, Chan NH, Chiu P, Lee KW, Ng CF. A randomized controlled trial comparing the efficacy of hybrid bipolar transurethral vaporization and resection of the prostate with bipolar transurethral resection of the prostate. J Endourol. 2011 Dec;25(12):1889-94. doi: 10.1089/end.2011.0269. Epub 2011 Sep 16.
PubMed 21923418
Teo JS, Lee YM, Ho HSS. An update on transurethral surgery for benign prostatic obstruction. Asian J Urol. 2017 Jul;4(3):195-198. doi: 10.1016/j.ajur.2017.06.006. Epub 2017 Jun 15.
PubMed 29264231
McVary KT, Gange SN, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Rousseau M, Beahrs JR, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Larson TR, Dixon CM, Roehrborn CG. Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2016 May;195(5):1529-1538. doi: 10.1016/j.juro.2015.10.181. Epub 2015 Nov 22.
PubMed 26614889
Cantrill CH, Zorn KC, Elterman DS, Gonzalez RR. The Rezum system - a minimally invasive water vapor thermal therapy for obstructive benign prostatic hyperplasia. Can J Urol. 2019 Jun;26(3):9787-9793.
PubMed 31180311
McVary KT, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Pliskin M, Beahrs JR, Prall D, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Tadros NN, Gange SN, Roehrborn CG. Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2021 Sep;206(3):715-724. doi: 10.1097/JU.0000000000001778. Epub 2021 Apr 19.
PubMed 33872051
McVary KT, El-Arabi A, Roehrborn C. Preservation of Sexual Function 5 Years After Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia. Sex Med. 2021 Dec;9(6):100454. doi: 10.1016/j.esxm.2021.100454. Epub 2021 Oct 30.
PubMed 34731779
McVary KT, Holland B, Beahrs JR. Water vapor thermal therapy to alleviate catheter-dependent urinary retention secondary to benign prostatic hyperplasia. Prostate Cancer Prostatic Dis. 2020 Jun;23(2):303-308. doi: 10.1038/s41391-019-0187-5. Epub 2019 Nov 18.
PubMed 31740738
Barry MJ, Williford WO, Chang Y, Machi M, Jones KM, Walker-Corkery E, Lepor H. Benign prostatic hyperplasia specific health status measures in clinical research: how much change in the American Urological Association symptom index and the benign prostatic hyperplasia impact index is perceptible to patients? J Urol. 1995 Nov;154(5):1770-4. doi: 10.1016/s0022-5347(01)66780-6.
PubMed 7563343
Ray AF, Powell J, Speakman MJ, Longford NT, DasGupta R, Bryant T, Modi S, Dyer J, Harris M, Carolan-Rees G, Hacking N. Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity-matched comparison with transurethral resection of the prostate (the UK-ROPE study). BJU Int. 2018 Aug;122(2):270-282. doi: 10.1111/bju.14249. Epub 2018 May 6.
PubMed 29645352
Yu SCH, Cho C, Hung E, Wang D, Chiu P, Yee CH, Ng A. Case-Control Study of Intra-arterial Verapamil for Intraprostatic Anastomoses to Extraprostatic Arteries in Prostatic Artery Embolization for Benign Prostatic Hypertrophy. J Vasc Interv Radiol. 2017 Aug;28(8):1167-1176. doi: 10.1016/j.jvir.2017.04.004. Epub 2017 May 13.
PubMed 28506701

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial Comparing Water Vapour Thermal Therapy (Rezūm) and TURP in Men With Benign Prostatic Hyperplasia in Refractory Urinary Retention
ClinicalTrials.gov ID: NCT05762198
Acronym / sponsor ID: CRE-2022.537-T
Conditions: Prostate Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Chinese University of Hong KongUniversity, hospital or other
Study start: 1 May 2023 (actual)
Primary completion: 30 Jun 2026 (actual)
Study completion: 30 Jun 2026 (actual)
First posted: 9 Mar 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Rezūm	Active comparator	Device: Rezūm
TURP	Active comparator	Device: TURP

Who may qualify

Ages: 50 to 80 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RezūmIn the REZUM arm, water vapour treatment is performed for all subjects under local anaesthesia.	Device	Rezūm
TURPIn the TURP arm, all men will receive TURP operation under general or spinal anaesthesia	Device	TURP

Primary outcome

Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment
Time frame: Baseline, 3 months, 6 months and 12 months after intervention
IPSS score ranging from 0-35 (the higher the worse)

7 secondary outcomes

Successful trial without catheter (TWOC) within 3 months
Time frame: At 3 months
Complication rate
Time frame: 30 days after intervention
Post-op quality of life score
Time frame: Baseline, 3 months, 6 months and 12 months after intervention
Change in voiding function in uroflowmetry
Time frame: Baseline, 3 months, 6 months and 12 months after intervention
Post-op International Index of Erectile function score
Time frame: Baseline, 3 months, 6 months and 12 months after intervention
Hospital stays of procedure
Time frame: On Discharge
Unplanned readmission rate after operation in 30 days
Time frame: 30 days after intervention

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
Background: PubMed 29938669Ng CF, Yee CH, Chan CK, Wong HM, Chiu PK, Tsu JH, Teoh JY, Ho KL. Bipolar transurethral vapourisation versus monopolar transurethral resection of prostate: a randomised controlled trial. Hong Kong Med J. 2017 Jun;23 Suppl 2(3):32-34. No abstract available.
Background: PubMed 28057992Yee CH, Wong JH, Chiu PK, Teoh JY, Chan CK, Chan ES, Hou SM, Ng CF. Secondary hemorrhage after bipolar transurethral resection and vaporization of prostate. Urol Ann. 2016 Oct-Dec;8(4):458-463. doi: 10.4103/0974-7796.192110.
Background: PubMed 26042336Yee CH, Wong JH, Chiu PK, Chan CK, Lee WM, Tsu JH, Teoh JY, Ng CF. Short-stay transurethral prostate surgery: A randomized controlled trial comparing transurethral resection in saline bipolar transurethral vaporization of the prostate with monopolar transurethral resection. Asian J Endosc Surg. 2015 Aug;8(3):316-22. doi: 10.1111/ases.12197. Epub 2015 Jun 3.
Background: PubMed 21923418Yip SK, Chan NH, Chiu P, Lee KW, Ng CF. A randomized controlled trial comparing the efficacy of hybrid bipolar transurethral vaporization and resection of the prostate with bipolar transurethral resection of the prostate. J Endourol. 2011 Dec;25(12):1889-94. doi: 10.1089/end.2011.0269. Epub 2011 Sep 16.
Background: PubMed 29264231Teo JS, Lee YM, Ho HSS. An update on transurethral surgery for benign prostatic obstruction. Asian J Urol. 2017 Jul;4(3):195-198. doi: 10.1016/j.ajur.2017.06.006. Epub 2017 Jun 15.
Background: PubMed 26614889McVary KT, Gange SN, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Rousseau M, Beahrs JR, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Larson TR, Dixon CM, Roehrborn CG. Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2016 May;195(5):1529-1538. doi: 10.1016/j.juro.2015.10.181. Epub 2015 Nov 22.
Background: PubMed 31180311Cantrill CH, Zorn KC, Elterman DS, Gonzalez RR. The Rezum system - a minimally invasive water vapor thermal therapy for obstructive benign prostatic hyperplasia. Can J Urol. 2019 Jun;26(3):9787-9793.
Background: PubMed 33872051McVary KT, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Pliskin M, Beahrs JR, Prall D, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Tadros NN, Gange SN, Roehrborn CG. Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2021 Sep;206(3):715-724. doi: 10.1097/JU.0000000000001778. Epub 2021 Apr 19.
Background: PubMed 34731779McVary KT, El-Arabi A, Roehrborn C. Preservation of Sexual Function 5 Years After Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia. Sex Med. 2021 Dec;9(6):100454. doi: 10.1016/j.esxm.2021.100454. Epub 2021 Oct 30.
Background: PubMed 31740738McVary KT, Holland B, Beahrs JR. Water vapor thermal therapy to alleviate catheter-dependent urinary retention secondary to benign prostatic hyperplasia. Prostate Cancer Prostatic Dis. 2020 Jun;23(2):303-308. doi: 10.1038/s41391-019-0187-5. Epub 2019 Nov 18.
Background: PubMed 7563343Barry MJ, Williford WO, Chang Y, Machi M, Jones KM, Walker-Corkery E, Lepor H. Benign prostatic hyperplasia specific health status measures in clinical research: how much change in the American Urological Association symptom index and the benign prostatic hyperplasia impact index is perceptible to patients? J Urol. 1995 Nov;154(5):1770-4. doi: 10.1016/s0022-5347(01)66780-6.
Background: PubMed 29645352Ray AF, Powell J, Speakman MJ, Longford NT, DasGupta R, Bryant T, Modi S, Dyer J, Harris M, Carolan-Rees G, Hacking N. Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity-matched comparison with transurethral resection of the prostate (the UK-ROPE study). BJU Int. 2018 Aug;122(2):270-282. doi: 10.1111/bju.14249. Epub 2018 May 6.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter Ka-Fung CHIU, FRCS, PhD principal investigator

Chinese University of Hong Kong

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Rezūm and TURP in people with Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment (time frame: Baseline, 3 months, 6 months and 12 months after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05762198, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.