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

Phase 4

Completed

Conditions: Benign Prostatic Hyperplasia

Interventions: Device: GreenLight HPS

Registration Number: NCT00465101

Lead Sponsor: American Medical Systems

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 150

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GreenLight HPS	GreenLight HPS	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment Success	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%

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Clinically-significant Improvement in Post-void Residual Urine Volume.	6 months post-treatment	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.	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.
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	5 Year Follow Up	Kaplan-Meier estimate of percentage of participants who experience retrograde ejaculation.
Percentage of Participants With Clinically-significant Improvement in Uroflow.	6 months post-treatment	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
Treatment-related Complication	3 months	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
Gross Hematuria	91 days	Kaplan-Meier estimate of percentage of participants who require a blood transfusion as a result of hematuria.
Percentage of Participants With Treatment Success	5 Years	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.

Trial Locations

Locations (9): Affiliates in Urology
🇺🇸
Detroit, Michigan, United States
Connecticut Clinical Reseach Center
🇺🇸
Middlebury, Connecticut, United States
UCLA
🇺🇸
Los Angeles, California, United States
Glickman Urological Institute
🇺🇸
Cleveland, Ohio, United States
Urology of Virginia
🇺🇸
Virginia Beach, Virginia, United States
North Fulton Urology, P.C.
🇺🇸
Roswell, Georgia, United States
PC Group/Universtiy Urology Association
🇺🇸
New York, New York, United States
Oklahoma University Health Science Center_Urology
🇺🇸
Oklahoma City, Oklahoma, United States
UT Southwestern Medical Center at Dallas
🇺🇸
Dallas, Texas, United States