RecruitingRecruiting
Comparing Rezum and Urolift
NCT06820606 · Chinese University of Hong Kong
In plain English
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Official title
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
About this study
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 criteria
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
Study design
Enrollment target: 120 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-01-01
Estimated completion: 2027-12-31
Last updated: 2025-02-14
Interventions
Device: RezumDevice: UroLift
Primary outcomes
- • Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment (Baseline, 3 months, 6 months and 12 months after intervention)
Sponsor
Chinese University of Hong Kong · other
Contacts & investigators
ContactPeter Ka-Fung CHIU · contact · peterchiu@surgery.cuhk.edu.hk · +852 3505 3933
All locations (1)
Prince of Wales Hospital, The Chinese University of Hong KongRecruiting
Hong Kong, Hong Kong