A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization
A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization
To gain clinical experience with the GreenLight HPS System, a system designed to vaporize and
 coagulate tissue in the treatment of benign prostatic hyperplasia to reduce lower urinary
 tract symptoms.
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