Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) Using Bead Block Microspheres

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. 30 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 Bead Block
microspheres 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, and 12 months post procedure.

Inclusion Criteria:

- Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical
treatment. Patients with indwelling foley catheters will be treated with culture
directed antibiotics one time for 5-7 days. The catheter will be removed so urodynamic
testing and cystoscopy can be completed as part of the screening visit. It will be
replaced when testing is completed.

- 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 ≥ 18 and IPSS bother score ≥ 3

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

- For men 45-59 years old: Prostate Specific Antigen) PSA < 2.5 (or) PSA 2.5-20 with a
documented negative biopsy within previous 12 months.

- For men >60: PSA < 4 (or) PSA 4-20 with a documented negative biopsy within previous
12 months.

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 if criteria are met at the 1 year
follow up 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 if criteria are
met at the 1 year follow up 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 if criteria are met at the 1 year
follow up 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
or if criteria are met at the 1 year follow up visit

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

- Current urethral strictures/Bladder neck contracture (BNC) (past urethral strictures
which have been treated successfully > 6 months prior are eligible)

- 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. VWD)

- 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), Photoselective Vaporization of the
Prostate (PVP)

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

- 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