Prostatic Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia (BPH)
Prostatic Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia (BPH)
This is an open-labeled, non-randomized feasibility study to evaluate the safety of prostate
 artery embolization (PAE) for the treatment of lower urinary tract symptoms attributed to
 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