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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, Hong Kong
RECRUITINGChanges in International Prostate Symptom Score (IPSS) at 12 months after treatment
IPSS score ranging from 0-35 (the higher the worse)
Time frame: Baseline, 3 months, 6 months and 12 months after intervention
Hospital stays of procedure
Measure the hours of in-patient hospitalisation
Time frame: From the time patient is hospitalised until the time he discharges
Number of days on Foley's catheter or self-catheterization after operation
Time frame: 30 days after intervention
Complication rate
Assessed by Clavien-Dindo classification
Time frame: 30 days after intervention
Post-op quality of life score (International Prostate QOL score)
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)
Time frame: Baseline, 3 months, 6 months and 12 months after intervention
Post-op quality of life score (EQ5D-5L questionnaire)
Change in quality of life assessed by Quality of life: EQ5D-5L questionnaire
Time frame: Baseline, 3 months, 6 months and 12 months after intervention
Change in voiding function in uroflowmetry (Maximum flow rate)
It is assessed by maximum flow rate (ml/s) in uroflowmetry
Time frame: Baseline, 3 months, 6 months and 12 months after intervention
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Change in voiding function in uroflowmetry (Post void volume)
It is assessed by post void volume (ml) in uroflowmetry
Time frame: Baseline, 3 months, 6 months and 12 months after intervention
Post-op erectile function (IIEF-EF)
Assessed by Erectile function and Ejaculatory function using International Index of Erectile Function Questionnaire - Erectile function domain (IIEF-EF)
Time frame: Baseline, 3 months, 6 months and 12 months after intervention
Post-op erectile function (MSHQ-EjD-SF)
Assessed by Erectile function and Ejaculatory function using Male Sexual Health Questionnaire - ejaculatory dysfunction (EjD) Short Form (MSHQ-EjD-SF)
Time frame: Baseline, 3 months, 6 months and 12 months after intervention
Unplanned readmission rate after operation in 30 days
Percentage of patients with unplanned readmission
Time frame: 30 days after intervention
Cost of procedure and related hospitalization
Time frame: At 12 months after treatment