Prostate Vaporization Techniques in Canadian Hospital
Prostate Vaporization Techniques in Canadian Hospital
Kingston General Hospital is committed to upgrading the surgical treatment platform for
 benign prostate surgery. Vaporization Surgery, either laser-vaporization or
 electo-vaporization is becoming a "standard" of therapy for benign prostatic hyperplasia
 rather than the traditional transurethral resection of the prostate. However many Canadian
 hospitals have been slow to adopt an updated program because of evolving competing technology
 systems as well as unknown cost, efficacy, complication and patient/surgeon satisfaction
 considerations. KGH has been recognized as a centre of excellence in evaluating medical
 therapy for BPH and studies from the institution have impacted BPH care nationally and
 abroad. Laser and other state of the art BPH surgical technologies are being purchased by
 Ontario hospitals, including the local area, with no prospective assessment process. Kingston
 is uniquely advantaged to undertake a randomized comparative study of two of the most
 promising technology platforms because the investigators have the experience and expertise to
 perform the study in a hospital and surgeon naive institution.

 The investigators propose to directly compare two vaporization techniques, laser and plasma
 vaporization systems. The investigators will be able to answer the most important questions
 in technology introduction and technique into our hospital system - cost, efficacy, safety
 and satisfaction. The results will inform KGH (and other similar Ontario centres) on the
 advantage or not (financial and patient care related) of investing in a BPH state of the art
 vaporization technology.
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.