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.