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

This study has been completed.
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Jean-Eric Tarride, St. Joseph's Healthcare Hamilton Identifier:
First received: September 6, 2007
Last updated: November 19, 2014
Last verified: November 2014
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
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

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

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:
  • International Prostatic Symptom Score (IPSS) [ Time Frame: 1, 3, 12 and 24 months post procedure ]
  • Peak or maximum urinary flow rate [ Time Frame: 1, 3 and 6 months post surgery ]
  • Post-void residual volume [ Time Frame: 1, 3, 6 month post procedure ]
  • Length of operation/procedure [ Time Frame: During procedure ]
  • Frequency of blood transfusion [ Time Frame: During procedure ]
  • Change in hemoglobin in recovery room [ Time Frame: Following procedure ]
  • Postoperative serum electrolytes (sodium, creatinine) in recovery room [ Time Frame: Following procedure ]
  • Duration of catheterization [ Time Frame: 10 days after procedure ]
  • Occurrence of urethral stricture or bladder neck contracture requiring re-operation [ Time Frame: up to 2 years after the procedure ]
  • Re-bleed rate requiring hospitalization [ Time Frame: 1 month after procedure ]
  • Prostate-specific antigen (PSA) value [ Time Frame: 3 months follow-up ]
  • Rate of re-operation [ Time Frame: At 1, 6, 12 and 24 months following intervention ]
  • Rate of re-catheterization [ Time Frame: 1, 6, 12 and 24 months following intervention ]
  • Rate of sexual dysfunction (SHIM) and/or retrograde ejaculation (specific question) [ Time Frame: Pre-op, 1, 3, 6 months ]
  • Use of medications for the treatment of bladder outlet obstruction [ Time Frame: 1, 3 and 6 months after intervention ]
  • Long-term durability of PVP and TURP (i.e. readmission, drug therapy) [ Time Frame: At 12 and 24 months after intervention ]
  • IPSS quality of life score (Bother-score) [ Time Frame: Pre-op, 1, 3, 6, 12 and 24 months ]
  • EQ-5D utility score [ Time Frame: Pre-op, 1, 3, 6, 12 and 24 months ]
  • Resource utilization: hospital length of stay, OR time, pain medications, follow-up care (e.g. urologist visits, lab tests) [ Time Frame: Pre-op, 1, 3, 6, 12 and 24 months ]
  • Productivity losses [ Time Frame: Pre-op, 1, 3, 6, 12 and 24 months ]

Enrollment: 164
Study Start Date: January 2008
Study Completion Date: October 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PVP
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.
Other Name: PVP
Active Comparator: TURP
Transurethral resection of the prostate.
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.
Other Name: TURP

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.

Ages Eligible for Study:   41 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00527371

Canada, Ontario
McMaster Institute of Urology at St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Trillium Health Centre
Mississauga, Ontario, Canada, L5B 1B8
The Scarborough Hospital
Scarborough, Ontario, Canada, M1P 2T7
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Ontario Ministry of Health and Long Term Care
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: Jean-Eric Tarride, PI, St. Joseph's Healthcare Hamilton Identifier: NCT00527371     History of Changes
Other Study ID Numbers: HTA 010-0706-01
Study First Received: September 6, 2007
Last Updated: November 19, 2014

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

Additional relevant MeSH terms:
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male processed this record on May 22, 2017