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Trial Title:
Comparing Water Vapour Thermal Therapy (Rezūm) and TURP
NCT ID:
NCT05762198
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Rezūm
Description:
In the REZUM arm, water vapour treatment is performed for all subjects under local
anaesthesia.
Arm group label:
Rezūm
Intervention type:
Device
Intervention name:
TURP
Description:
In the TURP arm, all men will receive TURP operation under general or spinal anaesthesia
Arm group label:
TURP
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.
Criteria for 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)
Gender:
Male
Gender based:
Yes
Minimum age:
50 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Prince of Wales Hospital, Chinese University of Hong Kong
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Peter Ka-Fung CHIU, FRCS, PhD
Phone:
852-3505-2625
Email:
peterchiu@surgery.cuhk.edu.hk
Start date:
May 1, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Chinese University of Hong Kong
Agency class:
Other
Source:
Chinese University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05762198
