RecruitingNot ApplicableNCT05762198

Comparing Water Vapour Thermal Therapy (Rezūm) and TURP

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

Sponsor

Chinese University of Hong Kong

Enrollment

108 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 50 YearsMax Age: 80 Years

Inclusion Criteria4

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 Criteria6

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)

Interventions

DEVICERezūm

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

DEVICETURP

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

Locations(1)

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, Hong Kong

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NCT05762198

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