Comparing Water Vapour Thermal Therapy (Rezūm) and TURP

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Device: Rezūm; Device: TURP

• Registration Number: NCT05762198
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-09
• Study Start: 2023-05-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05
• Primary Completion: 2026-04-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 108

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rezūm	Rezūm	-
TURP	TURP	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Unplanned readmission rate after operation in 30 days	30 days after intervention	Percentage of patients with unplanned readmission
Successful trial without catheter (TWOC) within 3 months	At 3 months	Percentage of patients successfully TWOC
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
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)
Hospital stays of procedure	On Discharge	Measure the hours of in-patient hospitalisation

Trial Locations

Locations (1)

Prince of Wales Hospital, Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong