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