Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH)

Inclusion Criteria:

- Diagnosed with symptomatic BPH.

- Peak Urine flow rate <12 ml/sec on voided volume of >125mL.

- AUA symptom score value ≥9(9).

- Signed informed consent.

Exclusion Criteria:

- Subjects whose pain response has been significantly decreased by any means (because
the subject's ability to detect pain is a treatment safety mechanism).

- Subject with a history of any illness or surgery that might confound the results of
the study " or impede the successful completion of trial"

- Subject with a history of any illness for which the Prolieve® treatment may pose
additional risk to the subject.

- Subject with the confirmed or suspected malignancy of the prostate

- Subject with the confirmed or suspected bladder cancer

- PSA >10 ng/mL

- Subject with previous treatment to the prostate (e.g., surgery, balloon dilation,
stents, laser, TUNA, or Indigo prostatectomy) and/or non-metallic urogenital implants
(e.g., penile prostheses, artificial urinary sphincters)

- Subject with prostate weighing <20 or >80g.

- Subject with previous pelvic irradiation or radial pelvic surgery

- Subject having large, obstructive middle lobe

- Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease.

- Subject with urethral stricture and/or bladder stones

- Active urinary tract infection.

- Subject with neurogenic bladder and/or sphincter abnormalities due to Parkinson's,
multiple sclerosis, cerebrovascular accident (CVA), diabetes, or other disease
process.

- Residual bladder volume >250 mL measured by ultrasound.

- Compromised renal function (i.e., serum creatinine levels above 1.8 mg/dL).

- Cardiac pacemaker or metallic implants or staples, etc. in the pelvic or femoral
area.

- Concomitant medicating of the following:

1. Bladder antispasmodics (Ditropan or Detrol) within one week of treatment, unless
there is documented evidence that the subject has been on the same drug dose for
at least three months with a stable voiding pattern. The drug dose will not be
altered or discontinued for the entrance into or throughout the study.

2. 5-alpha reductase inhibitors and gonadotropin releasing hormonal analog.

3. Alpha blockers, antidepressants, androgens, within one week of treatment.

- Subject interested in future fertility/fathering children.

- Subject with full urinary retention.

- Subject with bleeding disorder or liver dysfunction associated with a bleeding
disorder.

- Subject with prostatic urethra length of <1.2 cm or >5.5 cm.