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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05762198

Enrollment

108

Registered

2023-03-09

Start date

2023-05-01

Completion date

2026-06-30

Last updated

2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

50 Years to 80 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment	Baseline, 3 months, 6 months and 12 months after intervention	IPSS score ranging from 0-35 (the higher the worse)

Secondary

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

Countries

Hong Kong

Contacts

Primary ContactPeter Ka-Fung CHIU, FRCS, PhD

peterchiu@surgery.cuhk.edu.hk35051663

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026