Comparing Water Vapour Thermal Therapy (Rezūm) and TURP

Chinese University of Hong Kong108 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

108

Conditions

Prostate Cancer

Interventions

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

Eligibility

Sex: MALEMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Outcomes

Primary Outcomes

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

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

Time frame: Baseline, 3 months, 6 months and 12 months after intervention

Secondary Outcomes

Successful trial without catheter (TWOC) within 3 months

Percentage of patients successfully TWOC

Time frame: At 3 months

Complication rate

Assessed by Clavien-Dindo classification

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: Baseline, 3 months, 6 months and 12 months after intervention

Hospital stays of procedure

Measure the hours of in-patient hospitalisation

Time frame: On Discharge

Unplanned readmission rate after operation in 30 days

Central Contacts

Peter Ka-Fung CHIU, FRCS, PhD

CONTACT

35051663 peterchiu@surgery.cuhk.edu.hk

Data from ClinicalTrials.gov

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