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

NCT00465101 | Completed Phase 4 Results

• 1 other identifier: PE0603
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 9

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Treatment-related Complication

  3 months

• Percentage of Participants With Clinically-significant Improvement in Uroflow.

  6 months post-treatment

• Percentage of Participants With Clinically-significant Improvement in Post-void Residual Urine Volume.

  6 months post-treatment

• Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years.

  5 years

• Gross Hematuria

  91 days

Other Outcomes (6)

• Length of Hospital Stay (LOS)

  Peri-Operative Period

• Length of Catheterization (LOC)

  Recovery Period

• Length of Procedure (LOP)

  Procedure

Study Arms (1)

GreenLight HPS

OTHER

Device: GreenLight HPS

Interventions

GreenLight HPS DEVICE

Greenlight HPS laser system for treatment of BPH

GreenLight HPS

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American Medical Systems: lead

Study Sites (9)

UCLA

Los Angeles, California, 90095, United States

Location

Connecticut Clinical Reseach Center

Middlebury, Connecticut, 06762, United States

Location

North Fulton Urology, P.C.

Roswell, Georgia, 30076, United States

Location

Affiliates in Urology

Detroit, Michigan, 48186, United States

Location

PC Group/Universtiy Urology Association

New York, New York, 10016, United States

Location

Glickman Urological Institute

Cleveland, Ohio, 44195, United States

Location

Oklahoma University Health Science Center_Urology

Oklahoma City, Oklahoma, 73104, United States

Location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390-9110, United States

Location

Urology of Virginia

Virginia Beach, Virginia, 23454, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Follow-up of subjects was discontinued in August 2012 prior to most participants completing the assessment planned at 5 years. At the time of the discontinuation, all but five of the participants remaining on study had completed 3 years of follow-up.

Results Point of Contact

• Title: Mara M. LaRock, Senior Manager, Clinical Franchise Lead
• Organization: American Medical Systems

mara.larock@bsci.com

952-930-6000

Study Officials

• Claus G Roehrborn, MD

  UT Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 24, 2007
• Study Start: May 1, 2007
• Primary Completion: August 1, 2012
• Study Completion: January 1, 2013
• Last Updated: October 28, 2015
• Results First Posted: October 28, 2015

Record last verified: 2012-06

Locations

US (9)