Benign Prostatic Hyperplasia and Prostate Size Greater Than 90 Grams

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring ARTERY EMBOLIZATION, BPH Read More

Inclusion Criteria:

• Patient is aged 50-85 years
• Patient has signed informed consent
• Patient has experienced lower urinary tract symptoms (LUTS) for at least 1 year prior to study enrollment
• Patient has a prostate size larger than 90g as measured by transrectal ultrasound (TRUS)
• Patient has an IPSS score greater than or equal to 13
• Patient has a peak urine flow rate < 12 mL/sec
• Patient either:
• Refuses surgical treatment
• Is considered high risk for surgical treatment
• Patient is either:
• Refractory to medical treatment
• Contraindicated for medical treatment
• Patient must meet ONE of the following criteria:
• Baseline PSA ≤ 2.5ng/mL
• Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA ≥ 25% of total PSA (no biopsy required)
• Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA < 25% of total PSA AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months
• Baseline PSA >10 ng/mL AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months

Exclusion Criteria:

• History of prostate or bladder cancer, or currently being evaluated for cancer
• History of prostate or bladder cancer, or currently being evaluated for cancer
• Patient has taken alpha blockers within 4 weeks of screening
• Patient has experienced an irregular voiding pattern despite medical management with a stable 5-alpha reductase inhibitor dosage for 3 months or longer
• History of open prostate surgery, radiofrequency, or microwave therapy
• Previous open bladder or rectosigmoid colon surgery
• TURP within the last two years
• Patient has nodularity or induration detected upon digital rectal examination (DRE)
• Neurogenic bladder or other neurological disorder impacting bladder function
• Urethral stricture, bladder neck contracture, other potentially confounding bladder pathology, bladder disease, or confounding urethral pathology
• Acute urinary retention requiring an indwelling catheter
• Bladder atonia
• Active prostatitis or urinary tract infection
• Cystolithiasis within the past 3 months
• Serum creatinine >1.7mg/dL
• Coagulation disturbances not normalized by medical treatment
• Iodinated contrast allergy not controlled with 24-hour steroid preparation
• History of gelatin allergy
• History of pelvic irradiation
• History of severe peripheral vascular disease or known major iliac arterial occlusive disease
• History of smoking greater than 30 pack-years
• Interest in future fertility
• Significant cardiac or respiratory disease that the Investigator believes puts the patient at risk for a complication during the procedure
• Any other risks or factors that the Investigator believes puts the patient at risk for a complication during the procedure