French Aquablation Clinical Investigation Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
French Aquablation Clinical Investigation Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
Single arm, multi-center prospective clinical trial to determine the safety and effectiveness
 of the AQUABEAM System in the treatment of benign prostatic hyperplasia (BPH) in men 45 to 80
 years of age.
Inclusion Criteria:

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

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

 -  Age from 45 through 80 years.

 -  Prostate volume between 30mL and 80mL by transrectal ultrasound (TRUS) measured at
 baseline.

 Exclusion Criteria:

 -  BMI ≥ 42.

 -  IPSS total score <12.

 -  History of prostate cancer or clinically significant elevated PSA value.

 -  History of bladder cancer actively treated within 2 years prior to the surgical
 procedure.

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

 -  Active infection, including urinary tract infection within 72 hours of the treatment
 procedure.

 -  Prostatitis treated with antibiotics within 1 year of the surgical procedure.

 -  Subject ever diagnosed with urethral stricture, meatal stenosis, or bladder neck
 contracture, or has history of damage to external urinary sphincter.

 -  Subject has current diagnosis of stress urinary incontinence that requires treatment
 or daily pad or device use.

 -  Clinically significant abnormal serum creatinine measured within 30 days of treatment.

 -  Maximum urinary flow rate (Qmax) >15 mL/s or PVR > 300 mL measured by uroflowmetry
 test at baseline.

 -  Subject has been catheterized due to retention within 14 days prior to the surgical
 procedure.

 -  Subject has a history of intermittent self-catheterization.

 -  Previous prostate surgery or history of other lower urinary tract surgery such as e.g.
 urinary diversion, artificial urinary sphincter or penile prosthesis

 -  Subjects on anticoagulants or antiplatelet (if medication cannot be stopped before and
 after procedure) or known coagulopathy (except aspirin below 100mg/d)

 -  Any severe illness or psychiatric condition that would prevent study completion or
 confound study results.

 -  Subject taking systemic immune-suppressants including corticosteroids; unable to
 withhold non- steroidal anti-inflammatory agents (NSAIDs, including aspirin) for 3-5
 days prior to treatment except for low dose aspirin (e.g. less than 100mg).

 -  Participants using medications specifically for bladder muscle problems (e.g.,
 irritability). Use of medications with anticholinergic or similar properties is
 allowable provided the patient does not have documented adverse urinary side effects
 from these medications.

 -  Participating in another investigational study that could affect responses to the
 study device.

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