Comparing Rezum and Urolift

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Device: UroLift; Device: Rezum

Study type: Interventional

Funder types: Other

Identifiers

NCT06820606

CRE-2024.349-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 prostatic urethral lift (UroLift) arm.

Enrollment: 120 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male ≥ 50 years Symptomatic BPH International prostate symptom score (IPSS) ≥13 Prostate volume 30-80ml

Exclusion criteria

• History or high suspicion of prostate cancer
• Current urinary tract infection
• Refractory urinary retention or post-void residual (PVR) ≥250 mL
• Intravesical prostatic protrusion (IPP)>10mm
• Prior prostate surgery
• Known or suspected allergy to nickel, titanium, or polyester/polypropylene
• Urethral stricture, meatal stenosis, bladder neck contracture
• Neurogenic bladder and/or sphincter abnormalities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Rezum

Active Comparator group

Treatment:

Device: Rezum

UroLift

Active Comparator group

Treatment:

Device: UroLift