Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (Canada)

Exclusion Criteria

• •1. History of prostate or bladder cancer, pelvic radiation, untreated bladder stones, urethral strictures/bladder neck contracture (BNC), renal insufficiency (i.e. creatinine \> 1.4)
• •2. Neurogenic bladder, Parkinson's disease
• •3. Prior treatment for urinary incontinence
• •4. Micturition frequency AND urgency. Micturition frequency defined as \> 8 micturitions per 24 hours as assessed by a thorough subject history including the question: "On average, how many times do you void during a 24 hour period? // \< 4, 5-7, 8 or more." Urgency defined as an uncontrollable urge to void that occurs \> 3 per 24 hours as assessed through the subject history/question: "On average, how many times a day do you have an uncontrollable urgency to void? // 0, 1-2, 3 or more?"
• •5. Intravesical prostate lobe protrusion \> 1 cm on TRUS. Note: this is distinct from lateral lobes protruding up to the bladder such as an intravesical protrusion without median lobe
• •6. Active Urinary Tract Infection \[UTI\] (i.e. must have a screening urinalysis without signs of infection or a negative urine culture)
• •7. PVR \> 250 at time of enrollment or catheter dependent bladder drainage
• •8. History of chronic prostatitis within the last 5 years
• •9. Not able to temporarily discontinue aspirin, Coumadin, Plavix and any other anticoagulant at least seven days prior to the time of treatment
• •10. History of known bleeding disorders (e.g. von Willebrand disease)
• •11. Prior BPH prostate procedures (e.g. Transurethral Microwave Therapy \[TUMT\], TUNA, water induced thermotherapy, TURP, PVP)
• •12. Men with confirmed or suspected malignancy of the prostate based on a digital rectal exam (DRE), prostate biopsy or PSA \> 10 ng/mL. Men with free PSA \< 25% and with PSA within an age and race-specific range may only be enrolled after a negative biopsy. If a biopsy is required, the subject shall have a six-week waiting period between the biopsy and histotripsy treatment, if he is deemed eligible to participate in the study.
• •13. Men interested in future fertility
• •14. Declines or unable to provide informed consent
• •15. Non-English-speaker
• •16. Life expectancy estimated to be less than one year
• •17. Unable or unwilling to complete all required questionnaires and follow-up assessments
• •18. In the opinion of the investigator, it is not in the subject's best interest to participate in the study.