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

20:35 EDT 28th July 2014 | 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

Clinical Trials [209 Associated Clinical Trials listed on BioPortfolio]

Assessment of Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia

Assessment of efficacy of vardenafil in the treatment of subjects with symptomatic Benign Prostatic Hyperplasia. The purpose of this study is to find out whether vardenafil can improve th...

Effects of Chronic Use of Doxazosin in Men With Benign Prostatic Hyperplasia

In this study, we investigate the changes of the expression of alpha adrenergic receptor in the prostate tissue during 2-yr medication period in the man with benign prostatic hyperplasia....

The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months

A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.

A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.

A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.

PubMed Articles [1981 Associated PubMed Articles listed on BioPortfolio]

Proteomic analysis of patient tissue reveals PSA protein in the stroma of benign prostatic hyperplasia.

Benign prostatic hyperplasia (BPH) is an age-related disease frequently associated with lower urinary tract symptoms (LUTS) that involves hyperplasia of both epithelial and stromal cells. Stromal fibr...

Association of physician specialty and medical therapy for benign prostatic hyperplasia.

Despite little available evidence to determine whether recently introduced selective α-1 blockers and 5-α reductase inhibitors (5-ARIs) are superior to the existing agents in treating benign prostat...

Multicentre prospective crossover study of the 'prostatic urethral lift' for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia.

To assess the clinical effect of the 'prostatic urethral lift' (PUL) on lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) through a crossover design study.

Importance of prostate volume and urinary flow rate in prediction of bladder outlet obstruction in men with symptomatic benign prostatic hyperplasia.

To predict bladder outlet obstruction with parameters of non-invasive investigations for patients with symptomatic benign prostatic hyperplasia.

Toll-like receptor 10-1-6 gene cluster polymorphisms are not associated with benign prostatic hyperplasia in korean population.

Inflammation and infection have been associated with the pathogenesis of benign prostatic hyperplasia (BPH). Toll-like receptors (TLRs) play key roles in the innate immune system and initiate the infl...

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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Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Follow and track Urology News on BioPortfolio: Uro...

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