PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia
PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia
This is a trial to demonstrate the superiority of prostate artery embolization (PAE) over
 sham procedure in men with benign prostatic hyperplasia (BPH) induced lower urinary tract
 symptoms (LUTS). The trial will aim to enroll 108 patients at a 2:1 allocation over a 2 year
 period.
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.