Comparing Water Vapour Thermal Therapy (Rezūm) and TURP

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Device: TURP; Device: Rezūm

Study type: Interventional

Funder types: Other

Identifiers

NCT05762198

CRE-2022.537-T

Details and patient eligibility

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.

Enrollment: 108 estimated patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

108 participants in 2 patient groups

Rezūm

Active Comparator group

Treatment:

Device: Rezūm

TURP

Active Comparator group

Treatment:

Device: TURP