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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00465101
Recruitment Status : Completed
First Posted : April 24, 2007
Results First Posted : October 28, 2015
Last Update Posted : October 28, 2015
Information provided by (Responsible Party):
American Medical Systems

Brief 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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Device: GreenLight HPS Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Clinical Study for GreenLight HPS in the Treatment of Obstructive Benign Prostatic Hyperplasia (BPH)
Study Start Date : May 2007
Actual Primary Completion Date : August 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
GreenLight HPS Device: GreenLight HPS
Greenlight HPS laser system for treatment of BPH

Primary Outcome Measures :
  1. Percentage of Participants With Treatment Success [ Time Frame: 6 months ]
    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%

Secondary Outcome Measures :
  1. Treatment-related Complication [ Time Frame: 3 months ]

    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

  2. Percentage of Participants With Clinically-significant Improvement in Uroflow. [ Time Frame: 6 months post-treatment ]
    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

  3. Percentage of Participants With Clinically-significant Improvement in Post-void Residual Urine Volume. [ Time Frame: 6 months post-treatment ]
    A clinically significant improvement in post-void residual is defined as a decrease of at least 50ml from baseline to 6 months.

  4. Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years. [ Time Frame: 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.

  5. Gross Hematuria [ Time Frame: 91 days ]
    Kaplan-Meier estimate of percentage of participants who require a blood transfusion as a result of hematuria.

  6. Percentage of Participants With Treatment Success [ Time Frame: 5 Years ]
    Treatment success is determined on a per patient basis and is defined as a 50% or greater decrease in IPSS from baseline to the specified time point.

  7. Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity. [ Time Frame: Up to five years ]
  8. Occurrence of Retrograde Ejaculation [ Time Frame: 5 Year Follow Up ]
    Kaplan-Meier estimate of percentage of participants who experience retrograde ejaculation.

Other Outcome Measures:
  1. Length of Hospital Stay (LOS) [ Time Frame: Peri-Operative Period ]
    Defined as the time from admission to the healthcare facility until discharge (in hours).

  2. Length of Catheterization (LOC) [ Time Frame: Recovery Period ]
    Defined as the time the subject required an indwelling Foley catheter post treatment (in hours).

  3. Length of Procedure (LOP) [ Time Frame: Procedure ]
    Defined as the time from cystoscope insertion into the urethra to the time of cystoscope removal (in minutes).

  4. Length of Lasing (LOL) [ Time Frame: Procedure ]
    Total time the laser was on during the study procedure.

  5. Number of Fibers Used During Procedure [ Time Frame: Procedure ]
  6. Total Joules Used [ Time Frame: Procedure ]
    Total energy applied during the study procedure

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00465101

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United States, California
Los Angeles, California, United States, 90095
United States, Connecticut
Connecticut Clinical Reseach Center
Middlebury, Connecticut, United States, 06762
United States, Georgia
North Fulton Urology, P.C.
Roswell, Georgia, United States, 30076
United States, Michigan
Affiliates in Urology
Detroit, Michigan, United States, 48186
United States, New York
PC Group/Universtiy Urology Association
New York, New York, United States, 10016
United States, Ohio
Glickman Urological Institute
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Oklahoma University Health Science Center_Urology
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-9110
United States, Virginia
Urology of Virginia
Virginia Beach, Virginia, United States, 23454
Sponsors and Collaborators
American Medical Systems
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Principal Investigator: Claus G Roehrborn, MD UT Southwestern Medical Center at Dallas
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Responsible Party: American Medical Systems Identifier: NCT00465101    
Other Study ID Numbers: PE0603
First Posted: April 24, 2007    Key Record Dates
Results First Posted: October 28, 2015
Last Update Posted: October 28, 2015
Last Verified: June 2012
Keywords provided by American Medical Systems:
Benign Prostatic Hyperplasia
Transurethral resection of the prostate
Lower urinary tract symptoms
Photoselective vaporization of the prostate
enlarged prostate
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases