REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia 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.

• REZŪM (Device): Subjects randomized to receive the REZŪM treatment will receive standardized treatment, following the Instruction for Use.
• alpha blocker and 5-alpha reductase inhibitor (Drug), also known as Dual Drug Therapy: 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.

Primary outcomes

• International Prostate Symptom Score (IPSS) change [From Baseline to 12 months]: 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.
• Male Sexual Health Questionnaire (MSHQ) total score change [From Baseline to 12 months]: Change in MHSQ score will be compared between groups. MHSQ score ranges from 0 to 125 with higher scores indicating better outcomes.

Secondary outcomes

• Disease Progression [End of available follow-up, up to 24 months]: 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

Sex: Male, ages: 45 Years to any

Inclusion Criteria:

1. 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
2. Subject is willing and able to answer all domains of MSHQ
3. Completed IPSS questionnaire with score ≥ 13 within 6 months prior to enrollment
4. Peak urinary flow rate (Qmax): ≤ 15 ml/sec with minimum voided volume of ≥ 150 ml within 6 months prior to enrollment
5. Post-void residual (PVR) ≤250 ml within 6 months prior to enrollment
6. Prostate volume ≥ 30 ml as measured by transrectal ultrasound or Magnetic Resonance Imaging within 3 months prior to enrollment
7. Subject is willing and capable of providing informed consent
8. 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)
9. France subjects only: subjects must be affiliated to national security insurance

Exclusion Criteria:

1. Inability to participate in full duration of study
2. Prior surgical treatment for BPH
3. Increased risk of bleeding
4. Presence of Genitourinary Cancer or other pelvic cancer
5. Functional issues with bladder
6. Presence of active infection in genitourinary tract
7. Structural and Anatomic issues with urinary tract and renal function
8. Concomitant Drug Therapy
9. Temporal restraints and risks for general anaesthesia or comorbidity that would elevate risk of participation

• Romain Mathieu, Professor, Principal investigator, CHU Rennes, Hôpital Pontchaillou
• Evanguelos Xylinas, Ass. Prof., Principal investigator, Hôpital Bichat