Clinical trial NCT00465101: A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization
Official title: A Prospective Clinical Study for GreenLight HPS in the Treatment of Obstructive Benign Prostatic Hyperplasia (BPH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: American Medical Systems
Sponsor class: INDUSTRY
First posted: 2007-04-24
Enrollment: 150
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants With Treatment Success
timeFrame: 6 months
Secondary outcomes:
measure: Treatment-related Complication
timeFrame: 3 months
measure: Percentage of Participants With Clinically-significant Improvement in Uroflow.
timeFrame: 6 months post-treatment
measure: Percentage of Participants With Clinically-significant Improvement in Post-void Residual Urine Volume.
timeFrame: 6 months post-treatment
measure: Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years.
timeFrame: 5 years
measure: Gross Hematuria
timeFrame: 91 days
measure: Percentage of Participants With Treatment Success
timeFrame: 5 Years
measure: Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity.
timeFrame: Up to five years
measure: Occurrence of Retrograde Ejaculation
timeFrame: 5 Year Follow Up
Other outcomes:
measure: Length of Hospital Stay (LOS)
timeFrame: Peri-Operative Period
measure: Length of Catheterization (LOC)
timeFrame: Recovery Period
measure: Length of Procedure (LOP)
timeFrame: Procedure
measure: Length of Lasing (LOL)
timeFrame: Procedure
measure: Number of Fibers Used During Procedure
timeFrame: Procedure
measure: Total Joules Used
timeFrame: Procedure
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Middlebury
country: United States
facility: Connecticut Clinical Reseach Center
state: Connecticut
city: Roswell
country: United States
facility: North Fulton Urology, P.C.
state: Georgia
city: Detroit
country: United States
facility: Affiliates in Urology
state: Michigan
city: New York
country: United States
facility: PC Group/Universtiy Urology Association
state: New York
city: Cleveland
country: United States
facility: Glickman Urological Institute
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Health Science Center_Urology
state: Oklahoma
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
Study officials:
affiliation: UT Southwestern Medical Center at Dallas
name: Claus G Roehrborn, MD
role: PRINCIPAL_INVESTIGATOR
References: