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Multi-center, prospective, one-arm study. A maximum of 150 subjects will be enrolled. Qualifying patients will receive treatment using a 120w laser for enlarged prostate. Symptoms will be evaluated prior to treatment, and then at 3 and 6 months, followed by a yearly visit out to 5 years post treatment for a total of 7 visits. The purpose of the study is to document advantages of GreenLight HPS in a long-term clinical trial.
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Benign Prostatic Hyperplasia
Active, not recruiting
American Medical Systems
Published on BioPortfolio: 2014-07-23T21:29:39-0400
The purpose of this study is to gain information on the safety, efficacy, and quality of life in subjects who have had the GreenLight XPS procedure.
The duration of the study is expected to take approximately 3 years, which includes a recruitment period of approximately 12-months and 2 years (24-months) to complete procedure and follow...
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Benign Prostatic Hyperplasia (BPH)
An enlarged prostate (benign prostatic enlargement (BPE) or benign prostatic hyperplasia (BPH)) is common in men after the age of about 50. Having an enlarged prostate does not mean you have cancer. In some cases, an enlarged prostate can cause the ...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...