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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
American Medical Systems
ClinicalTrials.gov Identifier:
NCT00465101
First received: April 23, 2007
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Device: GreenLight HPS
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Clinical Study for GreenLight HPS in the Treatment of Obstructive Benign Prostatic Hyperplasia (BPH)

Resource links provided by NLM:


Further study details as provided by American Medical Systems:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: April 2007
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: GreenLight HPS
    Greenlight HPS laser system for treatment of BPH
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.

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465101

Locations
United States, California
UCLA
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
Investigators
Principal Investigator: Claus G Roehrborn, MD UT Southwestern Medical Center at Dallas
  More Information

No publications provided

Responsible Party: American Medical Systems
ClinicalTrials.gov Identifier: NCT00465101     History of Changes
Other Study ID Numbers: PE0603
Study First Received: April 23, 2007
Last Updated: June 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by American Medical Systems:
Benign Prostatic Hyperplasia
Transurethral resection of the prostate
Lower urinary tract symptoms
GreenLight
Laserscope
Photoselective vaporization of the prostate
enlarged prostate

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on September 14, 2014