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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Jean-Eric Tarride, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT00527371
First received: September 6, 2007
Last updated: May 7, 2013
Last verified: May 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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)

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • International Prostatic Symptom Score (IPSS) [ Time Frame: 1, 3, 12 and 24 months post procedure ] [ Designated as safety issue: No ]
  • Peak or maximum urinary flow rate [ Time Frame: 1, 3 and 6 months post surgery ] [ Designated as safety issue: No ]
  • Post-void residual volume [ Time Frame: 1, 3, 6 month post procedure ] [ Designated as safety issue: No ]
  • Length of operation/procedure [ Time Frame: During procedure ] [ Designated as safety issue: No ]
  • Frequency of blood transfusion [ Time Frame: During procedure ] [ Designated as safety issue: No ]
  • Change in hemoglobin in recovery room [ Time Frame: Following procedure ] [ Designated as safety issue: Yes ]
  • Postoperative serum electrolytes (sodium, creatinine) in recovery room [ Time Frame: Following procedure ] [ Designated as safety issue: Yes ]
  • Duration of catheterization [ Time Frame: 10 days after procedure ] [ Designated as safety issue: Yes ]
  • Occurrence of urethral stricture or bladder neck contracture requiring re-operation [ Time Frame: up to 2 years after the procedure ] [ Designated as safety issue: Yes ]
  • Re-bleed rate requiring hospitalization [ Time Frame: 1 month after procedure ] [ Designated as safety issue: Yes ]
  • Prostate-specific antigen (PSA) value [ Time Frame: 3 months follow-up ] [ Designated as safety issue: No ]
  • Rate of re-operation [ Time Frame: At 1, 6, 12 and 24 months following intervention ] [ Designated as safety issue: No ]
  • Rate of re-catheterization [ Time Frame: 1, 6, 12 and 24 months following intervention ] [ Designated as safety issue: No ]
  • Rate of sexual dysfunction (SHIM) and/or retrograde ejaculation (specific question) [ Time Frame: Pre-op, 1, 3, 6 months ] [ Designated as safety issue: No ]
  • Use of medications for the treatment of bladder outlet obstruction [ Time Frame: 1, 3 and 6 months after intervention ] [ Designated as safety issue: No ]
  • Long-term durability of PVP and TURP (i.e. readmission, drug therapy) [ Time Frame: At 12 and 24 months after intervention ] [ Designated as safety issue: No ]
  • IPSS quality of life score (Bother-score) [ Time Frame: Pre-op, 1, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • EQ-5D utility score [ Time Frame: Pre-op, 1, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Productivity losses [ Time Frame: Pre-op, 1, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 245
Study Start Date: January 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Active Comparator: 2
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

Locations
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
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

No publications provided

Responsible Party: Jean-Eric Tarride, PI, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT00527371     History of Changes
Other Study ID Numbers: HTA 010-0706-01
Study First Received: September 6, 2007
Last Updated: May 7, 2013
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014