RecruitingNot ApplicableNCT06820606

Comparing Rezum and Urolift

A Randomized Controlled Trial Comparing Efficacy and Cost Effectiveness of Water Vapour Thermal Therapy (Rezum) and Prostatic Urethral Lift (UroLift) in Men With Benign Prostatic Hyperplasia

Sponsor

Chinese University of Hong Kong

Enrollment

120 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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 prostatic urethral lift (UroLift) arm.

Eligibility

Sex: MALEMin Age: 50 Years

Inclusion Criteria1

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

Exclusion Criteria8

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

Interventions

DEVICERezum

In the REZUM arm, water vapour treatment will be preformed.

DEVICEUroLift

In the UroLift arm, prostatic urethral lift treatment will be performed.

Locations(1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong

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NCT06820606

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