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

Prospective, single-arm study

Inclusion Criteria:

1. Diagnosis of BPH and eligible for endoscopic BPH surgery including TURP, PVP,
electrovaporization.

2. Prostate volumes 30 - 80 gm based on transrectal ultrasound

3. Men ≥ 50 years of age

4. IPSS symptom score ≥ 13 and IPSS bother score > 2 (see Appendix B for IPSS
questionnaire)

5. Baseline peak flow rate Qmax ≤ 15 cc/s with voided volume at least 125 cc

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 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 [VWD]) and subjects
determined to have a bleeding disorder by prothrombin time (PT) and partial
thromboplastin time (PTT) tests.

11. Prior BPH prostate procedures (e.g. TUMT, TUNA, water induced thermotherapy [WIT],
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 PSA between
2.5 and 10 ng/mL may only be enrolled after a negative biopsy. If a prior prostate
biopsy was performed within one year of enrollment and was negative for cancer, repeat
biopsy is not required if in the investigator's judgment there is no clinical evidence
to support biopsy reassessment. If a biopsy is required, the subject shall have a
six-week waiting period between the biopsy and histotripsy treatment, if he is
otherwise 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.