Comparing Water Vapour Thermal Therapy (Rezūm) and TURP

NCT ID: NCT05762198

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rezūm

Group Type ACTIVE_COMPARATOR

Rezūm

Intervention Type DEVICE

In the REZUM arm, water vapour treatment is performed for all subjects under local anaesthesia.

TURP

Group Type ACTIVE_COMPARATOR

TURP

Intervention Type DEVICE

In the TURP arm, all men will receive TURP operation under general or spinal anaesthesia

Interventions

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Rezūm

In the REZUM arm, water vapour treatment is performed for all subjects under local anaesthesia.

Intervention Type DEVICE

TURP

In the TURP arm, all men will receive TURP operation under general or spinal anaesthesia

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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CHIU Ka Fung Peter

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Ka-Fung CHIU, FRCS, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Peter Ka-Fung CHIU, FRCS, PhD

Role: CONTACT

Facility Contacts

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Peter Ka-Fung CHIU, FRCS, PhD

Role: primary

852-3505-2625

References

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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.

Reference Type BACKGROUND
PMID: 29938669 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28057992 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26042336 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21923418 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29264231 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26614889 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31180311 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33872051 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34731779 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31740738 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7563343 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29645352 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28506701 (View on PubMed)

Other Identifiers

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CRE-2022.537-T

Identifier Type: -

Identifier Source: org_study_id

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