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Photoselective Vaporization of the Prostate Compared to Transurethral Resection of the Prostate for the Treatment of Benign Hyperplasia of the Prostate (PVP)

This study is currently recruiting participants.
Verified by St. Joseph's Healthcare, January 2008

Sponsors and Collaborators: St. Joseph's Healthcare
Ontario Ministry of Health and Long Term Care
Information provided by: St. Joseph's Healthcare
ClinicalTrials.gov Identifier: NCT00527371
  Purpose

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.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Device: GreenLight HPS (TM)laser system [Photoselective Vaporization of the prostate (PVP)]
Procedure: Transurethral resection of the prostate (TURP)
Phase IV

ChemIDplus related topics:   Potassium chloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Prospective Controlled Trial Comparing Photoselective Vaporization of the Prostate (PVP-120W) to Transurethral Resection of the Prostate (TURP) for the Treatment of Benign Hyperplasia of the Prostate (BPH)

Further study details as provided by St. Joseph's Healthcare:

Primary Outcome Measures:
  • The primary outcome is the change in International Prostatic Symptom Score (IPSS). [ Time Frame: 6-months after surgery versus baseline. ]

Secondary Outcome Measures:
  • Difference in clinical efficacy outcomes (e.g., peak urinary flow rate, post-void residual volumes, QOL, sexual function). Complication rates. Reinstitution of bladder medications. Durability of PVP and TRUP. Resource utilization and costs-effectiveness. [ Time Frame: outcome assessment measure time points vary ]

Estimated Enrollment:   245
Study Start Date:   January 2008
Estimated Study Completion Date:   January 2011
Estimated Primary Completion Date:   July 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Photoselective vaporization of the prostate.
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.
2: Active Comparator
Transurethral resection of the prostate.
Procedure: Transurethral resection of the prostate (TURP)
Transurethral resection of the prostate will be performed with a continuous flow resectoscope and unipolar cautery using a standard technique.

Detailed Description:

Following a review of treatments for benign prostatic hyperplasia (BPH) by the Medical Advisory Secretariat (MAS) of the Ontario Ministry of Health and Long-Term Care (MOHLTC), the Ontario Health Technology Advisory Committee (OHTAC) recommended that "a registry study be conducted to establish longer term effectiveness and complication rates for PVP given the likelihood of increasing diffusion of this technology". Since then, the Medical Devices Bureau of the Therapeutic Products Directorate, Health Canada, has licensed in April 30, 2007, a 120W-KTP laser system (Greenlight HPS (TM)) for sale in Canada. As several new 120W systems will be operating in Ontario in the coming months, there is an urgent need to evaluate the effectiveness, cost-effectiveness and durability of 120W PVP compared to conventional TURP in the treatment of patients with BPH.

  Eligibility
Ages Eligible for Study:   41 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Male over the age of 40
  • Diagnosed with symptomatic/obstructive symptoms secondary to BPH requiring surgical intervention as determined by their urologist
  • Experienced lower urinary tract symptoms (LUTS) secondary to BPH > 3 months in duration
  • IPSS value of > 12
  • Peak urinary flow < 15mL/sec on voided volume (minimum of 150 ml)
  • Prostate size, as measured by transrectal ultrasonography (TRUS), less than 100cc in volume
  • American Society of Anesthesiology (ASA) classification of physical status, class 1-3
  • Able to read, understand, and sign the Informed Consent
  • Willing and able to comply with all follow-up requirements including multiple follow-up visits

Exclusion Criteria:

  • Transvesically measured post-void residual volume >400 mL
  • Currently in urinary retention
  • Chronic urinary retention
  • Medications impairing bladder contractibility
  • Uncorrectable bleeding disorders or long- term anticoagulation that cannot be stopped
  • Recent myocardial infarction or coronary artery stent placement
  • Any of the following diseases which appear to involve the bladder: myasthenia gravis, diabetes neuropathy, multiple sclerosis, spinal cord injury or Parkinson disease
  • Any patient with idiopathic atonic bladder
  • Major pelvic fractures that involved damage to the external urinary sphincter
  • Recently completed definitive radiation therapy for prostate cancer
  • Active localized or systemic infections; including active urinary tract infection
  • Active cystolithiasis, urethral strictures, bladder neck contracture, or acute prostatitis affecting bladder function
  • If patient's PSA value > PSA age-adjusted normal value, patient needs to have a negative biopsy before participating in the study
  • Confirmed malignancy of the prostate
  • Bladder cancer treated with transurethral resection of bladder cancer (TURBT) within 12 months or any patients treated with Bacillius Calmette-Guerin (BCG)
  • Bilateral hydronephrosis on renal ultrasound
  • Urethral strictures or a residual volume >400 ml
  • Immunocompromised
  • Previous TURP
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527371

Contacts
Contact: Rebecca VandenEykel     905-522-1155 ext 35876     rvanden@mcmaster.ca    
Contact: Lisa Patterson     905-523-7284 ext 5256     patterl@mcmaster.ca    

Locations
Canada, Ontario
McMaster Institute of Urology at St. Joseph's Healthcare Hamilton     Recruiting
      Hamilton, Ontario, Canada, L8N 4A6
      Contact: Rebecca VandenEykel     905-522-1155 ext 35896     rvanden@mcmaster.ca    
      Principal Investigator: Paul Whelan, MD            
      Sub-Investigator: Leo Winter, MD            
      Sub-Investigator: Kevin Piercey, MD            
Trillium Health Centre     Not yet recruiting
      Mississauga, Ontario, Canada, L5B 1B8
      Principal Investigator: Gary McIsaac, MD            
The Scarborough Hospital     Recruiting
      Scarborough, Ontario, Canada, M1P 2T7
      Principal Investigator: Edward Woods, MD            
      Sub-Investigator: William Baldwin, MD            
      Sub-Investigator: Nick Logarakis, MD            

Sponsors and Collaborators
St. Joseph's Healthcare
Ontario Ministry of Health and Long Term Care

Investigators
Study Chair:     Jean-Eric Tarride, PhD     Program for Assessment of Technology in Health, St. Joseph's Healthcare/McMaster University    
Principal Investigator:     Gary McIsaac, MD     Trillium Health Centre    
Principal Investigator:     Edward Woods, MD     The Scarborough Hospital    
Principal Investigator:     Paul Whelan, MD     McMaster Institute of Urology at St. Joseph's Healthcare Hamilton    
  More Information


Responsible Party:   Programs for the Assessment of Technology in Health ( Dr. Jean-Eric Tarride, PhD )
Study ID Numbers:   HTA 010-0706-01
First Received:   September 6, 2007
Last Updated:   February 20, 2008
ClinicalTrials.gov Identifier:   NCT00527371
Health Authority:   Canada: Health Canada

Keywords provided by St. Joseph's Healthcare:
Benign hyperplasia of the prostate  

Study placed in the following topic categories:
Hyperplasia
Prostatic Diseases
Prostatic Hyperplasia
Genital Diseases, Male

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on October 16, 2008




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