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

A Prospective Clinical Study for GreenLight HPS in the Treatment of Obstructive Benign Prostatic Hyperplasia (BPH)

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: GreenLight HPS

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA
  • Connecticut
    • Middlebury, Connecticut, United States, 06762
      • Connecticut Clinical Reseach Center
  • Georgia
    • Roswell, Georgia, United States, 30076
      • North Fulton Urology, P.C.
  • Michigan
    • Detroit, Michigan, United States, 48186
      • Affiliates in Urology
  • New York
    • New York, New York, United States, 10016
      • PC Group/Universtiy Urology Association
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Glickman Urological Institute
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University Health Science Center_Urology
  • Texas
    • Dallas, Texas, United States, 75390-9110
      • UT Southwestern Medical Center at Dallas
  • Virginia
    • Virginia Beach, Virginia, United States, 23454
      • Urology of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: GreenLight HPS	Device: GreenLight HPS; Greenlight HPS laser system for treatment of BPH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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.	5 years
Gross Hematuria	Kaplan-Meier estimate of percentage of participants who require a blood transfusion as a result of hematuria.	91 days
Percentage of Participants With Treatment Success	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.	5 Years
Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity.		Up to five years
Occurrence of Retrograde Ejaculation	Kaplan-Meier estimate of percentage of participants who experience retrograde ejaculation.	5 Year Follow Up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay (LOS)	Defined as the time from admission to the healthcare facility until discharge (in hours).	Peri-Operative Period
Length of Catheterization (LOC)	Defined as the time the subject required an indwelling Foley catheter post treatment (in hours).	Recovery Period
Length of Procedure (LOP)	Defined as the time from cystoscope insertion into the urethra to the time of cystoscope removal (in minutes).	Procedure
Length of Lasing (LOL)	Total time the laser was on during the study procedure.	Procedure
Number of Fibers Used During Procedure		Procedure
Total Joules Used	Total energy applied during the study procedure	Procedure

Collaborators and Investigators

• Sponsor: American Medical Systems
• Investigators: Principal Investigator: Claus G Roehrborn, MD, UT Southwestern Medical Center at Dallas

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: April 23, 2007
• First Submitted That Met QC Criteria: April 23, 2007
• First Posted (Estimate): April 24, 2007

Study Record Updates

• Last Update Posted (Estimate): October 28, 2015
• Last Update Submitted That Met QC Criteria: September 24, 2015
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia; Lower urinary tract symptoms; Transurethral resection of the prostate; enlarged prostate; Photoselective vaporization of the prostate; GreenLight; Laserscope
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: PE0603