Prostatic Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia (BPH)

This pilot study will be a single center, open labeled, non-randomized feasibility study to
evaluate the initial safety of PAE for the treatment of symptomatic bladder outlet
obstruction. 50 adult male subjects will be enrolled in this study. If eligible patients will
undergo the prostate artery embolization procedure in the Interventional Radiology
department. An angiogram of the prostate arteries will be done. Small beads called
Embospheres will be injected into the prostate artery to slow blood flow to the prostate in
the hope of providing relief with minimal side effects and complications, for lower urinary
tract symptoms caused by BPH. After the procedure the patient will be followed at 4 weeks, 12
weeks, 6 months, 12 months post procedure and then annually for up to 4 years.

Inclusion Criteria:

- Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical
treatment.

- Ability to understand and the willingness to sign a written informed consent

- Prostate volumes 40 - 200 gm. May include 30-39 gm if the subject has a long history
of ineffective response to combination medical treatments (alpha-blocker and a 5-alpha
reductase inhibitor) for at least 6 months

- Men ≥ 45 years of age

- IPSS symptom score > 13 and IPSS bother score > 2

- Peak flow rate Qmax≤ 12 with voided volume ≥125 cc

Exclusion Criteria:

- History of prostate or bladder cancer, pelvic radiation, untreated bladder stones,

- On alpha-blockers within the past 2 weeks unless on a stable dose of medication, with
a stable urination pattern for 2 weeks prior to enrollment, and the willingness to
stay on the same dose for the duration of the study, or until stopping criteria is met
at the 12 month f/u visit, and or/part of a trial without catheter (TWOC) and patient
is currently in Acute Urinary Retention (AUR)

- On 5-alpha reductase inhibitors within the past 6 months unless on a stable dose of
medication with a stable urination pattern for 30 days prior to enrollment and the
willingness to stay on the same dose for the duration of the study or until stopping
criteria is met at the 12 month f/u visit .

- On phenylephrine, pseudoephedrine, imipramine, an anticholinergic or cholinergic
medication within the past 2 weeks unless on a stable dose of medication with a stable
urination pattern for 2 weeks prior to enrollment and the willingness to stay on the
same dose for the duration of the study or until stopping criteria is met at the 12
month f/u visit .

- On estrogen, androgen, any drug producing androgen suppression, or anabolic steroids
within the past 4 months unless on stable dose of medication for 30 days prior to
enrollment and the willingness to stay on the same dose for the duration of the study.

- Daily use of a pad or device for incontinence required.

- Urethral strictures, renal insufficiency (i.e. creatinine > 1.8)

- Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease
or other neurological diseases known to affect bladder function.

- Neurogenic bladder, Hypotonic Bladder

- Prior treatment for urinary incontinence

- Penile prosthesis.

- Artificial urinary sphincter.

- Documented bacterial prostatitis within the past year.

- Active urinary tract infection (UTI) unless in case of regular catheter dependence and
thought to represent colonization.

- History of chronic prostatitis within the last 1 year

- Known bleeding disorders (e.g. von willebrand disease (VWD))

- History of urethral strictures/bladder neck closure (BNC)

- Prior prostate procedures (e.g. Transurethral microwave therapy (TUMT), transurethral
needle ablation of the prostate (TUNA), water-induced thermotherapy (WIT),
transurethral resection of the prostate (TURP), photo-vaporization of the prostate
(PVP))

- Prior treatment for overactive bladder (e.g. intravesical botox)

- Prostate Specific Antigen (PSA) > 4.0, < 10.0 unless documented negative prostate
biopsy within past 2 years and is not thought to harbor prostatic malignancy in the
clinical opinion of the primary or co-investigator.

- Enrolled in another treatment trial for any disease within the past 30 days

- Declines or unable to provide informed consent

- Condition precluding catheter-based intervention (ie occluded vessel, severe
atheromatous disease)

- Any serious medical condition likely to impede successful completion of the study,
such as certain mental disorders, uncontrolled diabetes, cardiac arrhythmias, cardiac
disease including congestive heart failure, significant respiratory disease, or known
immunosuppression.

- A history of rectal malignancy

- Prior surgical prostate intervention

- Interest in future fertility

- Allergy to Iodinated contrast agents not responsive to steroid premedication regimen

- Contraindication to Conscious sedation