PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia

Inclusion criteria

• • Men ≥45 and ≤90 years presenting with benign prostatic hyperplasia with symptoms for at least 6 months that are refractory to medical management or in whom medications are contraindicated, not tolerated, or refused.

• International Prostate Symptom Score (I-PSS) score 14 or greater.
• Quality of Life (QoL) score ≥ 3
• Peak urinary flow (Qmax) less than or equal to 12 mL/s with void volume >125mL.
• Prostate volume greater than 30 cc as determined by ultrasound, MRI, or CT.
• Personal risk <40% based on the University of Texas San Antonio prostate cancer risk calculator or having a negative prostate biopsy for cancer within the last 24 months.
• Able to provide written consent.
• Not participating in any other investigational drug or device studies.

Exclusion criteria

• • History of biopsy-proven prostate cancer

• Renal insufficiency (glomerular filtration rates (GFR) less than 40mL/min/1.73 m2 who are not already on dialysis)
• Prior prostate surgery or intervention, including trans-urethral resection of the prostate, balloon dilation, stent implantation, laser prostatectomy, radiation, UroLift®, or hyperthermia
• Other bladder or urethral pathology requiring therapy, either in the past or currently, including neurogenic bladder, sphincteric abnormalities, bladder cancer, or other causes of bladder atonia.
• Other causes of urinary obstruction, such as strictures of urethra or ureters, not related to BPH
• Current decompensated congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression.
• Neurological disease, including multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, and previous spinal nerve surgery
• Patients with platelet count <50,000/μL or International Normalized Ratio (INR) >1.8, unless corrected for the procedure
• Active urinary tract infection. Patients must have a negative culture within 7 days of the procedure.
• Allergy to iodinated contrast agents unless pre-treated by corticosteroids.
• Acute urinary retention.
• Post void residual (PVR) > 250 mL with urodynamic evidence of atonic bladder. Patients with a PVR >250 but urodynamic testing consistent with obstruction will be allowed.
• Bladder stone within three months prior to the procedure.
• Hematuria not evaluated by Urologist for causes other than BPH.
• Previous rectal surgery (excluding hemorrhoidectomy) or history of rectal disease.
• Prior pelvic irradiation or radical pelvic surgery.

Imaging exclusion criteria:

• Internal iliac artery occlusion as determined by either CT or MRI.