Prostate Cancer
Conditions
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.
Interventions
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Hospital stays of procedure | From the time patient is hospitalised until the time he discharges | Measure the hours of in-patient hospitalisation |
| 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 | — |
| 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 |
Countries
Hong Kong
Contacts
Primary ContactPeter Ka-Fung CHIU
Outcome results
None listed