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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: GreenLight HPS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GreenLight HPS<br> | Device: GreenLight HPS<br>* Greenlight HPS laser system for treatment of BPH<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign Prostatic Hyperplasia, Transurethral resection of the prostate, Lower urinary tract symptoms, GreenLight, Laserscope, Photoselective vaporization of the prostate, enlarged prostate