3 Month Efficacy Evaluation (Compared to Baseline) Using Validated Symptom Assessment Tools (See Outcome Metrics for Details) Clinical Trial
Official title:
A Prospective Randomized Technology Assessment Trial of Prostate Vaporization Techniques in a 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.
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