Benign Prostatic Hyperplasia Clinical Trial
Official title:
A Prospective Clinical Study for GreenLight HPS in the Treatment of Obstructive Benign Prostatic Hyperplasia (BPH)
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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