Transperineal Laser Ablation for treatment of LUTS due to benign prostatic obstruction

The Echolaser® system is a new device for minimal invasive procedures. The
system works with a continuous wave laser operating at 1064 nm that induces
tissue coagulation. Light tissue interaction is very predictable which makes
medical laser application a repeatable and calculable process. The laser fibre
tip that transfers the light into the tissue carbonizes and becomes black. This
results in a heat component that leads to necrosis near the tip and coagulative
effects deeper in the tissue. The body cleans up treated tissue over time. Much
experience is gained with laser application in different organs and in the
prostate, as well with the Echolaser® system as with systems of other
manufacturers.
With age a large group of men experience voiding complaints. In the Netherlands
this effects up to 44% of men over 70. A part of these complaints originate
from the prostate, leading to lower urinary tract symptom due to benign
prostatic obstruction (BPO). Standard treatment for BPO is a transurethral
resection of the prostate or laser vaporization. As these techniques enter the
prostate via the urethra, they are invasive and require general or spinal
anaesthesia.
The Echolaser® system can be applied in treatment of BPO in a minimal invasive
setting, this is called transperineal laser ablation (TPLA). The Echolaser®
system is unique in the transperineal approach and the application of four
fibres simultaneously. Treatment of a larger area is possible due to the
multifibre approach, when compared to earlier systems. TPLA has been applied in
a population of men with LUTS due to BPO that were unfit for operation. The
technique has been proven to be feasible and safe in this population.
This pilot study aims to prove feasibility and safety of TPLA in men with LUTS
due to BPO that are fit for standard treatment. We hypothesize that TPLA will
be feasible and safe in men eligible for standard treatment for BPO.

The primary objective of this study is to prove feasibility and safety of TPLA
for LUTS due to BPO in healthy men. The secondary objectives are to determine
functional voiding, erectile outcomes and changes on imaging.

This study is set up as a prospective, multi centre, interventional pilot
study.

All subjects undergo a transperineal laser ablation of their prostate under
local anaesthesia using the Echolaser® system. Two to four laser fibres are
placed in the prostate and laser light induces coagulative necrosis.

The risks for participation in this study are related to the TPLA procedure. As
fibres are introduced in the prostate by needles this can lead to damage of
surrounding tissues. This can cause perforation of the urethra or bladder and
damage of vessels and nerves. As a result haemorrhage and infection can occur.
Furthermore, the prostatic tissue can become oedematous with a need for an
indwelling catheter for several days.
Several precaution actions will be undertaken to reduce the patients* risk. The
fibres are placed under ultrasound guidance by which the safety margins from
other structures can be controlled. Furthermore, TPLA will be performed under
antibiotic prophylaxis to prevent infection.
Advantage of TPLA is the minimal invasive procedure that requires only local
anaesthesia. The intention is to treat only the transition zone. This spares
the urethra with consequent reduced haematuria risk. And as the natural anatomy
is untouched, antegrade ejaculation is more likely to be preserved.
Furthermore, when spontaneous voiding is present following treatment, an
indwelling catheter is not needed.
Patients* burden in the follow-up exists of two additional outpatient clinic
visits with non-invasive uroflowmetry, compared to standard treatment.
Furthermore, follow-up includes two invasive prostate ultrasound imaging
investigations with contrast enhancing agents and four times four
questionnaires of in total 25 questions.
Compared to the standard treatment, TPLA has the advantage that general
anaesthesia is not required, resulting in a risk reduction of these risks. The
risks for haematuria, clot retention, TUR syndrome and urethral stricture are
reduced and an indwelling catheter for at least two days is not standard with
TPLA.
Concluding, TPLA exposes patients to treatment risks. However, these are equal
or less compared to standard treatment due to the minimal invasive approach.
The burden of the intensified follow-up beholds more frequent visits and two
invasive investigations. The burden is in our opinion acceptable.