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A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization (PVP)
This study is currently recruiting participants.
Study NCT00465101   Information provided by American Medical Systems
First Received: April 23, 2007   Last Updated: February 23, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

April 23, 2007
February 23, 2008
April 2007
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00465101 on ClinicalTrials.gov Archive Site
  • Safety, defined by the incident rate of treatment-related complications that occur within 3-months post-treatment. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Improvement in uroflow rate and decrease in post-void residual from baseline to 6-months. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Quality of Life from I-PSS, I-PSS, rate of absence of retrograde ejaculation and erectile dysfunction will be followed up to 5 years beginning at baseline, then at 3 and 6 months, 1-, 2-, 3-, 4-, and 5 years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Rate of peri-operative gross hematuria (0-14 days post-treatment) and delayed gross hematuria (greater than 14 days post-treatment). [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Safety, defined by the incident rate of treatment-related complications that occur within 3-months post-treatment.
  • Improvement in uroflow rate and decrease in post-void residual from baseline to 6-months.
  • Quality of Life from I-PSS, I-PSS, rate of absence of retrograde ejaculation and erectile dysfunction will be followed up to 5 years beginning at baseline, then at 3 and 6 months, 1-, 2-, 3-, 4-, and 5 years.
  • Rate of peri-operative gross hematuria (0-14 days post-treatment) and delayed gross hematuria (greater than 14 days post-treatment).
 
A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization
A Prospective Clinical Study for GreenLight HPS in the Treatment of Obstructive Benign Prostatic Hyperplasia (BPH)

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.

Phase IV
Interventional
Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Benign Prostatic Hyperplasia
Device: GreenLight HPS
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
150
April 2013
November 2008   (final data collection date for primary outcome measure)

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 I-PSS/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 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
Male
45 Years and older
No
Contact: Danette Bonogofsky 952-930-6492 Danette.Bonogofsky@ammd.com
Contact: Dan Merz 952-930-6544 Dan.Merz@ammd.com
United States
 
 
NCT00465101
Dan Merz, Male Health, Prostate Program Manger, American Medical Systems, Inc.
 
American Medical Systems
 
Principal Investigator: Claus G Roehrborn, MD UT Southwestern Medical Center at Dallas
American Medical Systems
February 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.