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PVP Compared to TURP for the Treatment of Benign Hyperplasia of the Prostate

NCT00527371 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2018-02-12

No results posted yet for this study

Summary

In patients with an enlarged prostate (benign prostatic hyperplasia), is treatment using photoselective vaporization of the prostate (PVP 120 Watt) as effective and cost-effective as the standard treatment of transurethral resection of the prostate (TURP)? A higher-power (120W) laser system has recently been approved by Health Canada for the treatment of an enlarged prostate. This system, which uses laser energy to vaporize the prostate tissue, will be compared with the current standard treatment of transurethral resection of the prostate. This newer generation laser may offer more efficient removal of prostate tissue with fewer complications and may result in clinical and economic benefits compared to the standard treatment. However, there have been no studies comparing the 120W laser with the standard transurethral resection of the prostate. This study will provide currently unavailable information for clinicians and decision makers.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DEVICE

GreenLight HPS (TM)laser system [Photoselective Vaporization of the prostate (PVP)]

Photoselective vaporization of the prostate will be performed using the GreenLight HPS (TM)laser system (American Medical Systems), which is a high-power (120W) potassium titanyl phosphate (KTP) laser which was licensed by Health Canada in April 2007.

PROCEDURE

Transurethral resection of the prostate

Transurethral resection of the prostate will be performed with a continuous flow resectoscope and unipolar cautery using a standard technique.

Sponsors & Collaborators

  • Ontario Ministry of Health and Long Term Care

    collaborator OTHER_GOV

  • St. Joseph's Healthcare Hamilton

    lead OTHER

Principal Investigators

  • Jean-Eric Tarride, PhD · Program for Assessment of Technology in Health, St. Joseph's Healthcare/McMaster University

  • Gary McIsaac, MD · Trillium Health Centre

  • Edward Woods, MD · The Scarborough Hospital

  • Paul Whelan, MD · McMaster Institute of Urology at St. Joseph's Healthcare Hamilton

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
41 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2013-02-28
Completion
2013-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00527371 on ClinicalTrials.gov