Comparing Rezum and Urolift

Not Applicable

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06820606
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-01
• Study First Submitted: 2025-01-24
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-05
• Study First Posted: 2025-02-11
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2027-09-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment	Baseline, 3 months, 6 months and 12 months after intervention	IPSS score ranging from 0-35 (the higher the worse)

Secondary Outcome Measures

Name	Time	Method
Hospital stays of procedure	From the time patient is hospitalised until the time he discharges	Measure the hours of in-patient hospitalisation
Number of days on Foley's catheter or self-catheterization after operation	30 days after intervention
Complication rate	30 days after intervention	Assessed by Clavien-Dindo classification
Post-op quality of life score (International Prostate QOL score)	Baseline, 3 months, 6 months and 12 months after intervention	Change in quality of life assessed by change in International Prostate QOL score (Ranges from 0 to 6; 0 being the best while 6 being the worst)
Post-op quality of life score (EQ5D-5L questionnaire)	Baseline, 3 months, 6 months and 12 months after intervention	Change in quality of life assessed by Quality of life: EQ5D-5L questionnaire
Change in voiding function in uroflowmetry (Maximum flow rate)	Baseline, 3 months, 6 months and 12 months after intervention	It is assessed by maximum flow rate (ml/s) in uroflowmetry
Change in voiding function in uroflowmetry (Post void volume)	Baseline, 3 months, 6 months and 12 months after intervention	It is assessed by post void volume (ml) in uroflowmetry
Post-op erectile function (IIEF-EF)	Baseline, 3 months, 6 months and 12 months after intervention	Assessed by Erectile function and Ejaculatory function using International Index of Erectile Function Questionnaire - Erectile function domain (IIEF-EF)
Post-op erectile function (MSHQ-EjD-SF)	Baseline, 3 months, 6 months and 12 months after intervention	Assessed by Erectile function and Ejaculatory function using Male Sexual Health Questionnaire - ejaculatory dysfunction (EjD) Short Form (MSHQ-EjD-SF)
Unplanned readmission rate after operation in 30 days	30 days after intervention	Percentage of patients with unplanned readmission
Cost of procedure and related hospitalization	At 12 months after treatment

Trial Locations

Locations (1)

Prince of Wales Hospital, The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong