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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
164
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.
Transurethral resection of the prostate will be performed with a continuous flow resectoscope and unipolar cautery using a standard technique.
McMaster Institute of Urology at St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Trillium Health Centre
Mississauga, Ontario, Canada
The Scarborough Hospital
Scarborough Village, Ontario, Canada
The primary outcome is the change in International Prostatic Symptom Score (IPSS).
Time frame: 6-months after surgery versus baseline.
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
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