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

Benign Prostatic Hyperplasia Clinical Trial

— PVP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00465101
• Other study ID #: PE0603
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2007
• Last updated: September 24, 2015
• Start date: May 2007
• Est. completion date: January 2013

Study information

• Verified date: June 2012
• Source: American Medical Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• GreenLight HPS
Greenlight HPS laser system for treatment of BPH

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
American Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of Hospital Stay (LOS)	Defined as the time from admission to the healthcare facility until discharge (in hours).	Peri-Operative Period	No
Other	Length of Catheterization (LOC)	Defined as the time the subject required an indwelling Foley catheter post treatment (in hours).	Recovery Period	No
Other	Length of Procedure (LOP)	Defined as the time from cystoscope insertion into the urethra to the time of cystoscope removal (in minutes).	Procedure	No
Other	Length of Lasing (LOL)	Total time the laser was on during the study procedure.	Procedure	No
Other	Number of Fibers Used During Procedure		Procedure	No
Other	Total Joules Used	Total energy applied during the study procedure	Procedure	No
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	Gross Hematuria	Kaplan-Meier estimate of percentage of participants who require a blood transfusion as a result of hematuria.	91 days	Yes
Secondary	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	Yes
Secondary	Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity.		Up to five years	No
Secondary	Occurrence of Retrograde Ejaculation	Kaplan-Meier estimate of percentage of participants who experience retrograde ejaculation.	5 Year Follow Up	Yes