Comparing Water Vapour Thermal Therapy (Rezūm) and TURP

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Rezūm
* Device: TURP


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rezūm<br> | Device: Rezūm<br>* In the REZUM arm, water vapour treatment is performed for all subjects under local anaesthesia.<br>|
| Active Comparator: TURP<br> | Device: TURP<br>* In the TURP arm, all men will receive TURP operation under general or spinal anaesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful trial without catheter (TWOC) within 3 months | Percentage of patients successfully TWOC | At 3 months | 
| Complication rate | Assessed by Clavien-Dindo classification | 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) | 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 | 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) | Baseline, 3 months, 6 months and 12 months after intervention | 
| Hospital stays of procedure | Measure the hours of in-patient hospitalisation | On Discharge | 
| Unplanned readmission rate after operation in 30 days | Percentage of patients with unplanned readmission | 30 days after intervention |