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

Chinese University of Hong Kong1 site in 1 country108 target enrollmentMay 1, 2023

ConditionsProstate Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Chinese University of Hong Kong
Enrollment: 108
Locations: 1
Primary Endpoint: Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment
Status: Recruiting
Last Updated: 12 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 1, 2023

End Date

June 30, 2026

Last Updated

12 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Chinese University of Hong Kong

Responsible Party

Principal Investigator

CHIU Ka Fung Peter

Professor

Chinese University of Hong Kong

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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)

Secondary Outcomes

Complication rate(30 days after intervention)
Successful trial without catheter (TWOC) within 3 months(At 3 months)
Post-op quality of life score(Baseline, 3 months, 6 months and 12 months after intervention)
Unplanned readmission rate after operation in 30 days(30 days 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)
Hospital stays of procedure(On Discharge)