A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization

Enlarged prostate or Benign Prostatic Hyperplasia (BPH) is one of the most common diseases
of aging men and can be associated with lower urinary tract symptoms (LUTS) such as having
to urinate very often, a sudden strong feeling of having to urinate, having to get up at
night to urinate, decreased and intermittent force of stream and the feeling of incomplete
bladder emptying. These symptoms affect quality of life by interfering with normal daily
activities and sleep patterns. When surgery is the best treatment option for the patient,
the most common technique is a "transurethral resection of the prostate" (TURP). TURP
involves removing the some of the extra tissue of the prostate gland. Even though TURP is a
good treatment, there are concerns about the frequency of complications following treatment
as well as the significant costs to patients, doctors, and insurance providers.

Photoselective vaporization of the prostate (PVP) is a relatively new technology that has
similar benefits with fewer side effects than TURP. PVP is a minimally invasive procedure
that uses a special high-energy laser to eliminate excess prostate tissue and seal the
treated area. This technology has been used for more than a decade with over 200,000
procedures performed worldwide.

The focus of this study is to 1) document the long-term advantages of GreenLight HPS 120w
and 2) to show that the stronger laser is a more flexible and efficient device which allows
for a shorter procedure time, may be done in an out-patient setting in healthy patients,
allows for shorter catheterization time, may result in a rapid urinary flow rate with
minimal side effects, and may allow a quick return to normal activities. This device has
been approved by the United States Food and Drug Administration (FDA) for treatment of
obstructive BPH.

Inclusion Criteria:

- All male subjects ≥ 45 years of age who have a history of symptomatic/obstructive
symptoms secondary to BPH greater than 3 months, an International Prostate Symptom
Score (IPSS) / American Urology Association (AUA) score >14, require surgical
intervention, and are an acceptable risk for anesthesia and surgery are eligible to
participate in this study

Exclusion Criteria:

- American Society of Anesthesiologists (ASA) classification of physical status > III

- An unstable cardiopulmonary disorder, previously or recently diagnosed by standard
methods

- A myocardial infarction or coronary artery stent placement within 6 months of the
treatment

- Neurogenic lower urinary dysfunction

- A post-void residual (PVR) volume ≥ 400 mL

- Pre-existing urinary incontinence

- Active localized or systemic infection, including urinary tract infection (UTI) or
prostatitis affecting bladder function

- Pre-existing damage of external urinary sphincter

- Presence of cystolithiasis, urethral stricture, or bladder neck contracture

- Prostate volume (PV), as measured by transrectal ultrasound (TRUS), less than 30cc or
greater than 200cc

- Previously confirmed or suspected malignancy of prostate or bladder, treated or
untreated

- Immunocompromised subjects

- Serious bleeding disorders and coagulopathy. For example: hemophilia or Von
Willebrand's disease

- Desire to preserve antegrade ejaculation

- Calcification of prostate tissue, usually after severe prostatitis

- Deemed unfit for laser vaporization as determined by the attending physician

- Enrollment in a concurrent clinical trial of any treatment (drug or device) that
could affect urogenital function without sponsors' approval

- Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all
follow-up requirements