Comparing Water Vapour Thermal Therapy (Rezūm) and TURP

May 4, 2025 updated by: CHIU Ka Fung Peter, Chinese University of Hong Kong

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Prince of Wales Hospital, Chinese University of Hong Kong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rezūm
Device: Rezūm
In the REZUM arm, water vapour treatment is performed for all subjects under local anaesthesia.
Active Comparator: TURP
Device: TURP
In the TURP arm, all men will receive TURP operation under general or spinal anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, 3 months, 6 months and 12 months after intervention

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Peter Ka-Fung CHIU, FRCS, PhD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 9, 2023

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 4, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2022.537-T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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