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

American Medical Systems150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Benign Prostatic Hyperplasia

Interventions

GreenLight HPSDEVICE

Greenlight HPS laser system for treatment of BPH

Eligibility

Sex: MALEMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All male subjects ≥ 45 years of age who have a history of symptomatic/obstructive symptoms secondary to BPH greater than 3 months, an International Prostate Symptom Score (IPSS) / American Urology Association (AUA) score \>14, require surgical intervention, and are an acceptable risk for anesthesia and surgery are eligible to participate in this study Exclusion Criteria: * American Society of Anesthesiologists (ASA) classification of physical status \> III * An unstable cardiopulmonary disorder, previously or recently diagnosed by standard methods * A myocardial infarction or coronary artery stent placement within 6 months of the treatment * Neurogenic lower urinary dysfunction * A post-void residual (PVR) volume ≥ 400 mL * Pre-existing urinary incontinence * Active localized or systemic infection, including urinary tract infection (UTI) or prostatitis affecting bladder function * Pre-existing damage of external urinary sphincter * Presence of cystolithiasis, urethral stricture, or bladder neck contracture * Prostate volume (PV), as measured by transrectal ultrasound (TRUS), less than 30cc or greater than 200cc * Previously confirmed or suspected malignancy of prostate or bladder, treated or untreated * Immunocompromised subjects * Serious bleeding disorders and coagulopathy. For example: hemophilia or Von Willebrand's disease * Desire to preserve antegrade ejaculation * Calcification of prostate tissue, usually after severe prostatitis * Deemed unfit for laser vaporization as determined by the attending physician * Enrollment in a concurrent clinical trial of any treatment (drug or device) that could affect urogenital function without sponsors' approval * Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all follow-up requirements

Locations (9)

UCLA

Los Angeles, California, United States

Connecticut Clinical Reseach Center

Middlebury, Connecticut, United States

North Fulton Urology, P.C.

Roswell, Georgia, United States

Affiliates in Urology

Outcomes

Primary Outcomes

Percentage of Participants With Treatment Success

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

Secondary Outcomes

Treatment-related Complication

Treatment-related events include the following: * Infection that requires IV antibiotics or re-hospitalization or prolongation of existing hospitalization * Perforation / injury of adjacent organ(s) * Bladder neck contracture(s) requiring re-catheterization after post-surgery catheter removal * Hematuria requiring transfusion * Urinary retention requiring corrective intervention * De novo erectile dysfuction (ED) * Transfusion secondary to procedure-related anemia * Post procedure incontinence secondary to damage to the external urinary sphincter * Any other treatment-related injury requiring intervention

Time frame: 3 months

Percentage of Participants With Clinically-significant Improvement in Uroflow.

A clinically significant improvement in uroflow is defined as an increase in peak urinary flow rate (Qmax) of at least five ml/sec from baseline to 6 months

Time frame: 6 months post-treatment

Percentage of Participants With Clinically-significant Improvement in Post-void Residual Urine Volume.

A clinically significant improvement in post-void residual is defined as a decrease of at least 50ml from baseline to 6 months.

Time frame: 6 months post-treatment

Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years.

Participant response to the question "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?". Values range from 0 ("Delighted") to 6 ("Terrible") with higher values indicating worse outcomes.

Data from ClinicalTrials.gov

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