Clinical trial NCT06820606: Comparing Rezum and Urolift
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 120
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment
timeFrame: Baseline, 3 months, 6 months and 12 months after intervention
Secondary outcomes:
measure: Hospital stays of procedure
timeFrame: From the time patient is hospitalised until the time he discharges
measure: Number of days on Foley's catheter or self-catheterization after operation
timeFrame: 30 days after intervention
measure: Complication rate
timeFrame: 30 days after intervention
measure: Post-op quality of life score (International Prostate QOL score)
timeFrame: Baseline, 3 months, 6 months and 12 months after intervention
measure: Post-op quality of life score (EQ5D-5L questionnaire)
timeFrame: Baseline, 3 months, 6 months and 12 months after intervention
measure: Change in voiding function in uroflowmetry (Maximum flow rate)
timeFrame: Baseline, 3 months, 6 months and 12 months after intervention
measure: Change in voiding function in uroflowmetry (Post void volume)
timeFrame: Baseline, 3 months, 6 months and 12 months after intervention
measure: Post-op erectile function (IIEF-EF)
timeFrame: Baseline, 3 months, 6 months and 12 months after intervention
measure: Post-op erectile function (MSHQ-EjD-SF)
timeFrame: Baseline, 3 months, 6 months and 12 months after intervention
measure: Unplanned readmission rate after operation in 30 days
timeFrame: 30 days after intervention
measure: Cost of procedure and related hospitalization
timeFrame: At 12 months after treatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital, The Chinese University of Hong Kong
Study officials:
References:
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