Prostate Vaporization Techniques in Canadian Hospital

To comparatively evaluate two state of the art vaporization techniques for transurethral prostatectomy, the Clarion Evolve Laser Vaporization System and the Olympus TURis Plasma Vaporization ("button" electrode) system. Both systems are approved for use by Health Canada for vaporization surgery of the prostate. Both techniques involve a vaporization ablation (laser and plasma mechanism respectively) of the prostate, rather than sequential excision (or cutting) of the prostate performed with our traditional TURP technique. Compared to a TURP, both of the two study techniques involve similar endoscopic access to the prostate, similar anesthetic requirements, similar post-operative catheterization but appear to differ in blood loss (less with vaporization techniques), hospital stay (inpatient stay for TURP compared to outpatient discharge for study techniques) and patient recovery (improved with proposed techniques).

The laser vaporization uses a dual wavelength (980 and 1470 nm) diode laser with a fibre that allows for contact vaporization ablation of the prostate. The hospital already uses a Clarion laser system for urinary stone lithotripsy. Clarion will provide the necessary equipment for this platform for the duration of the trial. The plasma vaporization uses a bipolar high frequency generator for vaporization and coagulation. The procedure is performed using a near-contact hovering technique and the tissue removal process is performed in a similar fashion as TURP. The hospital has recently purchased the Olympus platform and the extra equipment required for this study will be provided by Olympus for the study. These technology systems will be compared in a randomized single blinded controlled study in a "technology naive" hospital with "technology naive" surgeons. The primary outcome will be cost with satisfaction, efficacy, learning curve and safety as key outcomes.

Inclusion criteria

• Male at least 45 years of age.
• Peak urinary flow rate at least 4 ml/sec with a voided volume of at least 125 ml.
• IPPS symptom score ≥ 12 at screening visit.
• Prostate volume on DRE estimated to be > 30cc.
• Voluntarily signed informed consent agreement prior to the performance of any study procedures.

Exclusion criteria

• Any prior invasive intervention for BPH.
• PSA level greater than 10 ng/ml at screening without either a negative biopsy or documented explanation of why no biopsy was performed.
• Medical condition unfit for surgery
• History or current evidence of carcinoma of the prostate.
• Documented bacterial prostatitis within the past 3 months.
• Known severe bleeding disorder.
• Unable to follow protocol directions or sign informed consent due to organic brain or psychiatric disease.
• History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol.