Comparing Water Vapour Thermal Therapy (Rezūm) and TURP
Recruiting · NCT05762198 · Interventional (participants receive a specific treatment) · Lead sponsor: Chinese University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
RezūmTURP
What this trial is about
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.
Who can take part
Age range
50 Years to 80 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
1 location listed.
- Prince of Wales Hospital, Chinese University of Hong Kong - Hong Kong, Hong Kong