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

• Treatment success is determined on a per patient basis and is defined as [(baseline I-PSS - I-PSS at 6-months)/ baseline I-PSS] greater than or equal to 50% [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  

• Safety, defined by the incident rate of treatment-related complications that occur within 3-months post-treatment. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  
• Improvement in uroflow rate and decrease in post-void residual from baseline to 6-months. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  
• Quality of Life from I-PSS, I-PSS, rate of absence of retrograde ejaculation and erectile dysfunction will be followed up to 5 years beginning at baseline, then at 3 and 6 months, 1-, 2-, 3-, 4-, and 5 years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  
• Rate of peri-operative gross hematuria (0-14 days post-treatment) and delayed gross hematuria (greater than 14 days post-treatment). [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  

Device: GreenLight HPS
Greenlight HPS laser system for treatment of BPH

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.

Outcomes: Decrease in International Prostate Symptom (I-PSS), improvement in uroflow rate,and decrease in post-void residual score from baseline to 6 months. Rate of peri-operative and delayed hematuria will be captured and rate of absence of retrograde ejaculation and new onset of erectile dysfunction (ED). I-PSS, Quality of Life score from I-PSS, retrograde ejaculation and ED will be followed for 5 years. Length of time for patients to return to pre-treatment level of activity (excluding sex). Length of time for: hospital stay, catheterization, procedure, and lasing time. Number of fibers and total joules used per procedure will also be collected. Safety, defined by the incident rate of treatment-related complications that occur within 3 months post-treatment will be captured.