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

St. Joseph's Healthcare Hamilton

Status

Completed

Conditions

Benign Prostatic Hyperplasia

Treatments

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

Procedure: Transurethral resection of the prostate

Study type

Interventional

Funder types

Other

Identifiers

NCT00527371

HTA 010-0706-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

164 patients

Sex

Male

Ages

41+ years old

Volunteers

No Healthy Volunteers

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