A Prospective Randomized Technology Assessment Trial of Prostate Vaporization Techniques in a 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.