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

Primary Purpose

Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
GreenLight HPS
Sponsored by
American Medical Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Benign Prostatic Hyperplasia, Transurethral resection of the prostate, Lower urinary tract symptoms, GreenLight, Laserscope, Photoselective vaporization of the prostate, enlarged prostate

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA
  • Connecticut Clinical Reseach Center
  • North Fulton Urology, P.C.
  • Affiliates in Urology
  • PC Group/Universtiy Urology Association
  • Glickman Urological Institute
  • Oklahoma University Health Science Center_Urology
  • UT Southwestern Medical Center at Dallas
  • Urology of Virginia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

GreenLight HPS

Arm Description

Outcomes

Primary Outcome Measures

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%

Secondary Outcome Measures

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
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
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.
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.
Gross Hematuria
Kaplan-Meier estimate of percentage of participants who require a blood transfusion as a result of hematuria.
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.
Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity.
Occurrence of Retrograde Ejaculation
Kaplan-Meier estimate of percentage of participants who experience retrograde ejaculation.

Full Information

First Posted
April 23, 2007
Last Updated
September 24, 2015
Sponsor
American Medical Systems
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1. Study Identification

Unique Protocol Identification Number
NCT00465101
Brief Title
A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization
Acronym
PVP
Official Title
A Prospective Clinical Study for GreenLight HPS in the Treatment of Obstructive Benign Prostatic Hyperplasia (BPH)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Medical Systems

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Benign Prostatic Hyperplasia, Transurethral resection of the prostate, Lower urinary tract symptoms, GreenLight, Laserscope, Photoselective vaporization of the prostate, enlarged prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GreenLight HPS
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
GreenLight HPS
Intervention Description
Greenlight HPS laser system for treatment of BPH
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment Success
Description
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
Secondary Outcome Measure Information:
Title
Treatment-related Complication
Description
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
Time Frame
3 months
Title
Percentage of Participants With Clinically-significant Improvement in Uroflow.
Description
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
Time Frame
6 months post-treatment
Title
Percentage of Participants With Clinically-significant Improvement in Post-void Residual Urine Volume.
Description
A clinically significant improvement in post-void residual is defined as a decrease of at least 50ml from baseline to 6 months.
Time Frame
6 months post-treatment
Title
Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years.
Description
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.
Time Frame
5 years
Title
Gross Hematuria
Description
Kaplan-Meier estimate of percentage of participants who require a blood transfusion as a result of hematuria.
Time Frame
91 days
Title
Percentage of Participants With Treatment Success
Description
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.
Time Frame
5 Years
Title
Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity.
Time Frame
Up to five years
Title
Occurrence of Retrograde Ejaculation
Description
Kaplan-Meier estimate of percentage of participants who experience retrograde ejaculation.
Time Frame
5 Year Follow Up
Other Pre-specified Outcome Measures:
Title
Length of Hospital Stay (LOS)
Description
Defined as the time from admission to the healthcare facility until discharge (in hours).
Time Frame
Peri-Operative Period
Title
Length of Catheterization (LOC)
Description
Defined as the time the subject required an indwelling Foley catheter post treatment (in hours).
Time Frame
Recovery Period
Title
Length of Procedure (LOP)
Description
Defined as the time from cystoscope insertion into the urethra to the time of cystoscope removal (in minutes).
Time Frame
Procedure
Title
Length of Lasing (LOL)
Description
Total time the laser was on during the study procedure.
Time Frame
Procedure
Title
Number of Fibers Used During Procedure
Time Frame
Procedure
Title
Total Joules Used
Description
Total energy applied during the study procedure
Time Frame
Procedure

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus G Roehrborn, MD
Organizational Affiliation
UT Southwestern Medical Center at Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Connecticut Clinical Reseach Center
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Facility Name
North Fulton Urology, P.C.
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Affiliates in Urology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48186
Country
United States
Facility Name
PC Group/Universtiy Urology Association
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Glickman Urological Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oklahoma University Health Science Center_Urology
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
UT Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9110
Country
United States
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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