A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: GreenLight HPS
Intervention description: Greenlight HPS laser system for treatment of BPH
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Benign Prostatic Hyperplasia; Transurethral resection of the prostate; Lower urinary tract symptoms; GreenLight; Laserscope; Photoselective vaporization of the prostate; enlarged prostate

Summary:

      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.
    

Eligibility criteria:

        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