The study objective is to compare water vapor thermotherapy with the REZŪM™ System to dual drug therapy for the treatment of symptomatic benign prostatic hyperplasia refractory to alpha-blocker monotherapy in sexually active men.
STUDY OBJECTIVE - To compare water vapor thermotherapy with the REZŪM™ System to dual drug therapy for the treatment of symptomatic benign prostatic hyperplasia refractory to alpha-blocker monotherapy in sexually active men. STUDY DESIGN - Multicenter open-label randomized controlled parallel-group post-market trial. STUDY TREATMENTS AND RANDOMIZATION - Subjects will be randomly assigned to REZŪM or dual drug therapy treatments; 1:1 randomization via the electronic data capture (EDC) system. Both treatments are commercially available. Subjects randomized to receive the REZŪM treatment will receive standardized treatment and subjects randomized to dual drug therapy will receive the local formulary preferred choice of urinary selective alpha blocker and 5-alpha reductase inhibitor. VISIT SCHEDULE - Study visits are at: enrollment/baseline, treatment, 3 months, 6 months, and yearly follow-up through 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
155
Subjects randomized to receive the REZŪM treatment will receive standardized treatment, following the Instruction for Use.
Subjects assigned to dual drug therapy will be treated with the local formulary preferred choice of commercially available urinary selective alpha blocker and 5-alpha reductase inhibitor. This arm will therefore represent local standard of care.
Epworth Healthcare
Melbourne, Australia
Australian Clinical Trials
Wahroonga, Australia
International Prostate Symptom Score (IPSS) change
Primary Statistical Hypothesis: Change in IPSS score will be compared between groups. IPSS score ranges from 0 to 35 with higher scores indicating worse symptoms.
Time frame: From Baseline to 12 months
Male Sexual Health Questionnaire (MSHQ) total score change
Change in MHSQ score will be compared between groups. MHSQ score ranges from 0 to 125 with higher scores indicating better outcomes.
Time frame: From Baseline to 12 months
Disease Progression
Disease progression, defined as occurrence of any of the following: * Surgical retreatment for LUTS/BPH * Urinary retention requiring urinary catheterization after 90 days post-treatment * IPSS increase from baseline by ≥ 4 points * Introduction of a new drug agent to treat LUTS/BPH
Time frame: End of available follow-up, up to 24 months
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