REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Water Vapor Thermotherapy vs. Combination Pharmacotherapy for Symptomatic Benign Prostatic Hyperplasia Refractory to Alpha Blocker Monotherapy in Sexually Active Men: A Multicenter Randomized Controlled Trial

Conditions
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Benign Prostatic Hyperplasia (BPH)

Intervention / Treatment
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* Device: REZŪM
* Drug: alpha blocker and 5-alpha reductase inhibitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sexually active male subjects ≥ 45 years of age who have persistent non-neurogenic lower urinary tract symptoms refractory to first-line treatment with single agent Alpha Adrenoceptor Antagonist therapy Subject is willing and able to answer all domains of MSHQ Completed IPSS questionnaire with score ≥ 13 within 6 months prior to enrollment Peak urinary flow rate (Qmax): ≤ 15 ml/sec with minimum voided volume of ≥ 150 ml within 6 months prior to enrollment Post-void residual (PVR) ≤250 ml within 6 months prior to enrollment Prostate volume ≥ 30 ml as measured by transrectal ultrasound or Magnetic Resonance Imaging within 3 months prior to enrollment Subject is willing and capable of providing informed consent Subject is willing and capable of participating in all visits associated with this study at an approved clinical study site and at the intervals defined by this Clinical Investigational Plan (CIP) France subjects only: subjects must be affiliated to national security insurance Exclusion Criteria: Inability to participate in full duration of study Prior surgical treatment for BPH Increased risk of bleeding Presence of Genitourinary Cancer or other pelvic cancer Functional issues with bladder Presence of active infection in genitourinary tract Structural and Anatomic issues with urinary tract and renal function Concomitant Drug Therapy Temporal restraints and risks for general anaesthesia or comorbidity that would elevate risk of participation

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: REZŪM<br>Subjects randomized to receive the REZŪM treatment will receive standardized treatment, following the Instruction for Use (IFU). The REZŪM System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men with a prostate volume ≥ 30 ml. The REZŪM System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe. 1:1 randomization will occur via the electronic data capture (EDC) system. | Device: REZŪM<br>* Subjects randomized to receive the REZŪM treatment will receive standardized treatment, following the Instruction for Use.<br>|
| Active Comparator: Dual Drug Therapy<br>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. | Drug: alpha blocker and 5-alpha reductase inhibitor<br>* 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.<br>* Other names: Dual Drug Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate, REZŪM, Water vapor thermotherapy, Lower urinary tract symptoms, BPH, LUTS