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.
Who can participate
Age range45 Years
SexMALE
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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)
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
What they're measuring
1
International Prostate Symptom Score (IPSS) change
Timeframe: From Baseline to 12 months
2
Male Sexual Health Questionnaire (MSHQ) total score change