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REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men
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 details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 45 and older
Healthy volunteers accepted : No
Gender eligible for study: Male
Things to know
Study dates
Study start: 2021-09-15
Primary completion: 2026-02-01
Study completion finish: 2027-02-01
Study type
TREATMENT
Phase
NA
Trial ID
NCT04838769
Intervention or treatment
DEVICE: REZŪM
DRUG: alpha blocker and 5-alpha reductase inhibitor
Conditions
- • Benign Prostatic Hyperplasia (BPH)
Find a site
Closest Location:
Epworth Healthcare
Research sites nearby
Select from list below to view details:
Epworth Healthcare
Melbourne, Not Specified, Australia
Australian Clinical Trials
Wahroonga, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
ACTIVE_COMPARATOR: REZŪM
| DEVICE: REZŪM
|
ACTIVE_COMPARATOR: Dual Drug Therapy
| DRUG: alpha blocker and 5-alpha reductase inhibitor
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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. | 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. | From Baseline to 12 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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 | End of available follow-up, up to 24 months |
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