Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

This is a investigator-initiated evaluation of the safety and efficacy of treating benign
prostatic hyperplasia (BPH) by prostatic artery embolization.

Inclusion Criteria:

Inclusion Criteria:

- Male, 45 years or older

- Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hyperplasia refractory
to medical therapy for at least 6 months.

- IPSS score at initial evaluation should be greater than 12, and uroflowmetry (Qmax) of
<15mL/s (milliliters per second).

- All prostate volumes will be > 40gm

- PSA which meets 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;Negative
prostate biopsy (minimum 12 cores within 12 months) if abnormal digital rectal
examination.

Exclusion Criteria:

- Patients with active urinary tract infections or recurrent urinary tract infections (>
2/year), prostatitis, or interstitial cystitis.

- Cases of biopsy proven prostate, bladder, or urethral cancer.

- Patients on long-term narcotic analgesia, androgen therapy, or GNRH
(gonadotropin-releasing hormone) analogue therapy who are unwilling to stop therapy
for 2 months prior to the study.

- Use of anithistamines, anti-convulsants, and antispasmodics within one week of
treatment unless they have been treated with the same drug (at the same dosage) for at
least 6 months and has an associated stable voiding pattern.

- Patients who are classified as New York Heart Association Class III (Moderate), or
higher, have cardiac arrhythmias, have uncontrolled diabetes, or are known to be
immunosuppressed.

- Hypersensitivity reactions to contrast material not manageable with prophylaxis.

- Patients with glomerular filtration rates less than 40 who are not already on dialysis

- Prostate volume <40 mL

- Patients with bilateral internal iliac arterial occlusion

- Patients with causes of bladder obstruction not due to BPH (eg urethral stricture,
bladder neck contraction, etc)

- Patients with neurogenic or bladder atonia

- Prior prostatectomy

- Cystolithiasis within the last 3 months

- Patients interested in future fertility

- Patients with a life expectancy less than 1 year

- Patients where embolization is not possible distal to collateral vessels feeding
non-prostatic tissue

- Patients with major neurologic illnesses which could have symptoms that may be similar
to or confused for BPH (eg Parkinson's disease, multiple sclerosis, Shy-Drager
syndrome, spinal cord injury, etc.).

- Patients with urethral stents

- Patients who have undergone prior rectal surgery other than hemorrhoidectomy or pelvic
irradiation.

- Patients who have started or changed their dosage of alpha blockers or 5-alpha
reductase inhibitors in the month prior to PAE