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

21:54 EDT 26th March 2015 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Benign Prostatic Hyperplasia

Intervention

GreenLight HPS

Location

UCLA
Los Angeles
California
United States
90095

Status

Active, not recruiting

Source

American Medical Systems

Results (where available)

View Results

Links

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PubMed Articles [1761 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).

An orally active TESTOSTERONE 5-ALPHA-REDUCTASE inhibitor. It is used as a surgical alternative for treatment of benign prostatic hyperplasia.

Benign proliferation of the ENDOMETRIUM in the UTERUS. Endometrial hyperplasia is classified by its cytology and glandular tissue. There are simple, complex (adenomatous without atypia), and atypical hyperplasia representing also the ascending risk of becoming malignant.

A plant genus of the family BRASSICACEAE that is an ingredient of the preparation PC-SPES that is used to treat PROSTATIC HYPERPLASIA.

A plant genus in the family ARECACEAE, order Arecales, subclass Arecidae. The fruit or the extract (Permixon) is used for PROSTATIC HYPERPLASIA.

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