NCT05762198

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
2mo left

Started May 2023

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
May 2023Jun 2026

First Submitted

Initial submission to the registry

February 28, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

May 7, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

February 28, 2023

Last Update Submit

May 4, 2025

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment

    IPSS score ranging from 0-35 (the higher the worse)

    Baseline, 3 months, 6 months and 12 months after intervention

Secondary Outcomes (7)

  • Successful trial without catheter (TWOC) within 3 months

    At 3 months

  • Complication rate

    30 days after intervention

  • Post-op quality of life score

    Baseline, 3 months, 6 months and 12 months after intervention

  • Change in voiding function in uroflowmetry

    Baseline, 3 months, 6 months and 12 months after intervention

  • Post-op International Index of Erectile function score

    Baseline, 3 months, 6 months and 12 months after intervention

  • +2 more secondary outcomes

Study Arms (2)

Rezūm

ACTIVE COMPARATOR
Device: Rezūm

TURP

ACTIVE COMPARATOR
Device: TURP

Interventions

RezūmDEVICE

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

Rezūm
TURPDEVICE

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

TURP

Eligibility Criteria

Age50 Years - 80 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (13)

  • 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.

    PMID: 29938669BACKGROUND

  • 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.

    PMID: 28057992BACKGROUND

  • 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.

    PMID: 26042336BACKGROUND

  • 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.

    PMID: 21923418BACKGROUND

  • 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.

    PMID: 29264231BACKGROUND

  • 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.

    PMID: 26614889BACKGROUND

  • 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.

    PMID: 31180311BACKGROUND

  • 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.

    PMID: 33872051BACKGROUND

  • 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.

    PMID: 34731779BACKGROUND

  • 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.

    PMID: 31740738BACKGROUND

  • 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.

    PMID: 7563343BACKGROUND

  • 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.

    PMID: 29645352BACKGROUND

  • 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.

    PMID: 28506701BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Peter Ka-Fung CHIU, FRCS, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Ka-Fung CHIU, FRCS, PhD

CONTACT

35051663peterchiu@surgery.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 9, 2023

Study Start

May 1, 2023

Primary Completion

April 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

May 7, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)