Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II

Inclusion Criteria:

- Male age 45-80 years.

- Subject has diagnosis of lower urinary tract symptoms due to benign prostatic
enlargement causing bladder outlet obstruction.

- Subject has an IPSS score greater than or equal to 12.

- Maximum urinary flow rate (Qmax) less than 15mL/s.

- Serum creatinine < 2 mg/dL within 30 days of surgery.

- History of inadequate or failed response, contraindication, or refusal to medical
therapy.

- Prostate size ≥ 80 mL and ≤ 150 mL as measured by TRUS.

- Patient is mentally capable and willing to sign a study-specific informed consent
form.

Exclusion Criteria:

- BMI ≥ 42.

- Patients unable to stop anticoagulants, antiplatelet agents, or non-steroidal
anti-inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior
to treatment per standard of care.

- Participants using systemic immune-suppressants including corticosteroids (except
inhalants); unable to withhold non-steroidal anti-inflammatory agents (NSAIDs,
including aspirin) prior to treatment per standard or care except for low dose aspirin
(e.g. less than or equal to 100mg).

- Contraindication to both general and spinal anesthesia.

- Any severe illness that would prevent complete study participation or confound study
results.

- History of prostate cancer or current/suspected bladder cancer. Prostate cancer should
be ruled out before participation to the satisfaction of the investigator if PSA is
above acceptable thresholds.

- History of actively treated bladder cancer within the past two (2) years.

- Clinically significant bladder calculus or bladder diverticulum (e.g., pouch size >20%
of full bladder size).

- Active infection, including urinary tract infection or prostatitis.

- Urinary catheter use daily for 90 or more days consecutively.

- Previous urinary tract surgery such as e.g. urinary diversion, artificial urinary
sphincter or penile prosthesis.

- Ever been diagnosed with a clinically significant urethral stricture or meatal
stenosis, or bladder neck contracture.

- Known damage to external urinary sphincter.

- Has had an open heart surgery, or cardiac arrest < 180 days prior to the date of
informed consent.

- Participants using anticholinergics specifically for bladder problems. Use of
medications with anticholinergic properties is allowable provided the patient does not
have documented adverse urinary side effects from these medications.

- Subject is unwilling to accept a transfusion should one be required.