Benign Prostatic HyperplasiaPhase 4PVPNCT00465101
A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization
A Phase 4 study testing GreenLight HPS in people with Benign Prostatic Hyperplasia, run by American Medical Systems at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- GreenLight HPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 9 sitesUnited States
- Study dates
- May 2007to Jan 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Glickman Urological Institute
Cleveland, Ohio, 44195
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390-9110
Affiliates in Urology
Detroit, Michigan, 48186
UCLA
Los Angeles, California, 90095
Connecticut Clinical Reseach Center
Middlebury, Connecticut, 06762
PC Group/Universtiy Urology Association
New York, New York, 10016
Oklahoma University Health Science Center_Urology
Oklahoma City, Oklahoma, 73104
North Fulton Urology, P.C.
Roswell, Georgia, 30076
Urology of Virginia
Virginia Beach, Virginia, 23454
About this study
Official title: 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.
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- GreenLight HPS
- Keywords
- Benign Prostatic Hyperplasia, Transurethral resection of the prostate, Lower urinary tract symptoms, GreenLight, Laserscope, Photoselective vaporization of the prostate, enlarged prostate
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GreenLight HPSDevice
Greenlight HPS laser system for treatment of BPH
| Study group | Role | What they receive |
|---|---|---|
| GreenLight HPS | Other | Not described Receives: Device: GreenLight HPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 6 months
Secondary outcomes (8)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 5 years
Gross Hematuria
Kaplan-Meier estimate of percentage of participants who require a blood transfusion as a result of hematuria.
Measured: 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.
Measured: 5 Years
Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity.
Measured: Up to five years
Occurrence of Retrograde Ejaculation
Kaplan-Meier estimate of percentage of participants who experience retrograde ejaculation.
Measured: 5 Year Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionAug 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claus G Roehrborn, MD, Principal investigator, UT Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465101
- Sponsor's protocol ID
- PE0603
- Acronym
- PVP
- Status last verified
- Jun 2012
- First submitted
- 23 Apr 2007
- Last updated
- 28 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study for GreenLight HPS in the Treatment of Obstructive Benign Prostatic Hyperplasia (BPH)
- ClinicalTrials.gov ID
- NCT00465101
- Acronym / sponsor ID
- PVP / PE0603
- Conditions
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- American Medical SystemsIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 24 Apr 2007 (estimated)
- Results
- Posted 28 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GreenLight HPS | Other | Device: GreenLight HPS |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GreenLight HPSGreenlight HPS laser system for treatment of BPH | Device | GreenLight HPS |
Primary outcome
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%
8 secondary outcomes
Treatment-related Complication
Time frame: 3 months
Percentage of Participants With Clinically-significant Improvement in Uroflow.
Time frame: 6 months post-treatment
Percentage of Participants With Clinically-significant Improvement in Post-void Residual Urine Volume.
Time frame: 6 months post-treatment
Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years.
Time frame: 5 years
Gross Hematuria
Time frame: 91 days
Percentage of Participants With Treatment Success
Time frame: 5 Years
Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity.
Time frame: Up to five years
Occurrence of Retrograde Ejaculation
Time frame: 5 Year Follow Up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claus G Roehrborn, MD principal investigator
UT Southwestern Medical Center at Dallas
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GreenLight HPS in people with Benign Prostatic Hyperplasia, run by American Medical Systems at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Treatment Success (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2015.