EURURO Vol. 72 No. 6

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into the median lobe. Of course, the total number of
injections may vary according to prostate size and length of
the urethra.
[25_TD$DIFF]3.9.2. Clinical outcome
Clinical 1-yr outcomes of men with LUTS due to BPE treated
in smaller pilot trials provided first evidence for efficacy and
safety of the Rezu- m system In the first multicentre,
randomised, controlled study 197 men were enrolled and
randomised in a 2:1 ratio to treatment with the Rezu- m
system or control . The mock procedure was rigid
cystoscopy with imitated treatment sounds. The primary
efficacy end point was met at 3 mo with relief of symptoms
measured by a change in IPSS of 50% for the treatment arm
compared to 20% for the control group (p < 0.0001). In the
thermal treatment arm, Qmax increased significantly by 67%
from 9.9 ml/s to 16.1 ml/s (p < 0.0001) after 3 mo and this
positive clinical outcome was sustained throughout the
study period with an improvement of 54% at the 12-mo
follow up. No relevant impact was observed on postvoid
residual urine volume. Outcome for QoL was significantly
improved 2 wk after intervention and followed a positive
trend over the study period with a meaningful treatment
response of 51% at 12 mo (p < 0.0001). Further validated
objective outcome measures such as BPHII, Overactive
Bladder Questionnaire Short Form for overactive bladder
bother, and impact on QoL and International Continence
Society Male Item Short Form Survey for male incontinence
demonstrated significant amelioration of symptoms at the
3-mo follow-up with sustained efficacy throughout the
study period of 12 mo. Direct comparison of determined
end points at the 3-mo follow-up including IPSS, Qmax,
BPHII, Overactive Bladder Questionnaire Short Form proved
statistically significant superiority of the thermal therapy
over the shamprocedure. Safety profile was favourable with
adverse events documented to be mild to moderate and
resolving rapidly. Of note, almost 69% received only oral
sedation and in contrast to most of the novel minimally
invasive techniques all critical prostatic zones including the
middle lobe were successful treated. Preservation of erectile
and ejaculatory function after convective water vapor
thermal therapy was demonstrated utilizing validated
outcome instruments such as IIEF and Male Sexual Health
Questionnaire-Ejaculation Disorder Questionnaire . The
recently reported 2-yr results confirmed durability of the
positive clinical outcome after convective water vapour
energy ablation . The first clinical experience suggests
that this novel technique of prostatic ablation is able to
provide rapid and meaningful relief of LUTS without
compromising sexual function. Further RCTs are needed
to confirm these promising first clinical results and to
evaluate mid-term and long-term efficacy and safety of the
Rezu- m system.
[26_TD$DIFF]3.10. Prostatic artery embolization
[27_TD$DIFF]3.10.1. Basic principle
One of the first nominal case reports of prostatic
artery embolization (PAE) was a necessary therapeutic
intervention with an unexpected positive side effect. A
76-yr-old patient with relevant cardiac comorbidities
precluding standard surgical intervention and a compli-
cated course of BPE refractory to pharmacotherapy
developed recurrent episodes of acute urinary retention
and persistent gross haematuria After unilateral
super-selective transarterial prostate embolization col-
leagues were not only successful in managing prostatic
bleeding instantly, but observed also some treatment
effect on his male LUTS/BPE. The obvious advantage of
PAE is that it can be performed as a 1-d case under local
anaesthesia for the access through the femoral arteries.
Digital subtraction angiography displays arterial anatomy
and the appropriate prostatic arterial supply is selectively
embolized using nonspherical polyvinyl alcohol to effect
stasis in treated prostatic vessels. Among centres a debate
is still ongoing considering the efficacy of a unilateral
approach and the benefit of a bilateral approach
. At the moment, PAE is exclusively performed
by interventional radiologists at specialised centres.
Atherosclerosis, excessive tortuosity of the arterial supply
and the presence of adverse collaterals are anatomical
obstacles for the technical approach. Nontargeted embo-
lization may therefore lead to ischaemic complications
like transient ischaemic proctitis, bladder ischaemia, or
seminal vesicles ischaemia . Short-term compli-
cations including urethral burning sensation, nausea and
vomiting are common and have been coined the ‘‘post-
PAE syndrome’’ The extended duration of the
procedure with the requirement of fluoroscopy brings
the risk of a relevant radiation exposure, which may
result in skin irritation, and even burns But
constantly modified low-dose protocols and pulsed frame
rate digital subtraction angiography appear to reduce
efficiently radiation dosage. Furthermore, contrast toxic-
ity with the need for angiography is another adverse
effect that needs to be acknowledged.
[28_TD$DIFF]3.10.2. Clinical outcome
In 2013 the prospective nonrandomised trial by Pisco et al
evaluated PAE in 255 patients for the treatment of
moderate to severe LUTS due to BPE at a single centre. The
technical procedure, defined as either unilateral or bilateral
embolization, was technically successful in 97.9% and 88%
of treated patients were discharged on the same day of
intervention. In this study, the mean procedure time was
73 min and the mean fluoroscopy time was 18 min, which is
among the shortest fluoroscopy times mentioned in the
literature and should therefore not be considered represen-
tative for the procedure. Clinical outcome parameters
demonstrated efficacy of PAE. At the 3-mo follow-up a
significant impact on LUTS as measured by IPSS with a mean
reduction from 24 to 11 points and an improvement in QoL
with a mean change from 4.4 to 2.23 points were reported
(both p < 0.0001). Qmax increased from 9.2 ml/s to 12.4 ml/s
and postvoid residual urine volume decreased from
102.9 ml to 59.2 ml (both p < 0.0001). Mean prostate
volume changed from 83.5 cc to 68.3 cc at 3 mo. The
positive treatment responses were stable up to 12 mo.
E U R O P E A N U R O L O G Y 7 2 ( 2 0 1 7 ) 9 8 6 – 9 9 7 993