EURURO Vol. 72 No. 6

991 1030

be performed under local anaesthesia in an outpatient
setting and in most cases no postinterventional catheter-
isation is required.
[18_TD$DIFF]3.7.2. Clinical outcome
Efficacy and safety were confirmed in the multicentre,
prospective, randomised, controlled, and blinded L.I.F.T
study enrolling 206 patients who were randomized 2:1
between PUL and sham . The primary end point at 3 mo
was met with a 50% reduction in American Urological
Association Symptom Index from baseline 22.1 points to
11 points ( p < 0.0001). This improvement was 88% greater
than the change in the sham control group and was stable
during the study period of 12 mo. At 3 mo, Qmax increased
significantly by 64% from 8.1 ml/s to 12.4 ml/s (p < 0.0001)
in the PUL group and remained stable up to 12 mo. The
therapeutic effect on voiding parameters like Qmax was
more pronounced than in the control arm (p < 0.005). So
was the case with changes for quality of life assessment and
additional outcome measure like the Benign Prostatic
Hyperplasia Impact Index (BPHII). No relevant influence
of PUL was observed for postvoid residual urine volume.
Safety profile was favourable with adverse events reported
to be mild to moderate and resolved within 2 wk. Evaluation
of sexual function utilising instruments like the IIEF score,
and the Male Sexual Health Questionnaire-Ejaculation
Disorder Questionnaire demonstrated no compromising
impact of PUL on erectile and ejaculatory function. With
regard to durability it is important to highlight that the
rapid clinical response after PUL was stable in follow-up
evaluations up to 5 yr. Recently, at the annual meeting of
the European Association of Urology 2017 the follow-up
data of the L.I.F.T study was presented . The initial
improvements in IPSS and Quality of Life (QoL) 1 mo after
PUL were 44% and 42% (p < 0.001), respectively, and
changes remained improved at the 5-yr assessment with
38% for IPSS and 54% for QoL (p < 0.001). The increase in
Qmax was still 41% at 5 yr. Sexual function was preserved
through 5 yr. In 2015, data of a prospective, randomised,
controlled trial at 10 European centres on 80 men with LUTS
due to BPE was published comparing clinical outcomes after
PUL with the reference method TURP . A novel objective
outcome tool termed BPH6 was introduced, whose clinical
significance has not been evaluated yet. It is composed of
the following six domains to evaluate various aspects of
efficacy and safety: relief from LUTS, recovery experience,
erectile function, ejaculatory function, continence preser-
vation, and safety. Significant amelioration of LUTS was
achieved for both procedures. Impact on IPSS, Qmax, and
postvoid residual urine volume was considerably stronger
after TURP ( p < 0.05), whereas PUL was superior to TURP in
terms of quality of recovery (p = 0.008) and preservation of
ejaculatory function metrics (p < 0.0001). No relevant
difference was reported for erectile function, incontinence,
and safety. Reinterventions due to insufficient treatment
response over the study period of 12 mo were necessary in
6.8% and 5.7% of patients after PUL and TURP, respectively.
The 2-yr results of the BPH6 study confirmed superiority of
TURP over PUL regarding IPSS and Qmax, whereas PUL
showed sustainable benefit over TURP for quality of
recovery and ejaculatory function . Throughout the 2-
yr follow-up six patients in the PUL arm (13.6%) and two
patients treated with TURP (5.7%) underwent secondary
intervention due to return of LUTS. Additional clinical trials
and meta-analysis of good quality substantiate that PUL
indeed is a minimally invasive procedure able to provide
rapid and durable relief of LUTS with acceptable re-
intervention rates without compromising sexual function
. As a consequence, PUL has been introduced
in the spectrum of surgical treatment options for the
management of male LUTS due to BPE by current guidelines
. Nevertheless, further studies are warranted to evaluate
long-term efficacy and safety and to define the position of
PUL among various treatment modalities.
[19_TD$DIFF]3.8. Novel techniques of tissue ablation
[20_TD$DIFF]3.8.1. Aquablation – image guided robotic waterjet ablation:
AquaBeam
[21_TD$DIFF]3.8.1.1. Basic principle. AquaBeam (Procept BioRobotics, Red-
wood Shores, CA, USA) represents a novel and innovative
high-end technology in the field of minimally invasive
treatment options for LUTS due to BPE. It uses the principle
of hydrodissection to effectively ablate prostatic parenchy-
ma while sparing collagenous structures like blood vessels
and the surgical capsule. A targeted high velocity saline
stream ablates prostatic tissue without the generation of
thermal energy, which in turn minimises the risk of thermal
injury or collateral tissue damage. Combining waterjet
ablation with the obvious benefits of real-time transrectal
ultrasound guidance and the accuracy of robotic assistance
makes AquaBeam one of the most engineered and targeted
approaches for selective ablation of the prostate. The
system is composed of three main components: the
console/pump, the robotic-controlled hand-piece, and a
transrectal ultrasound probe ). The hand-piece is
advanced through a 22-F cystoscope sheath until the device
is located within the bladder. Next, the hand-piece is locked
in place and registered within the prostate and using a
biplane transrectal ultrasound probe. Now the surgeon is
able to complete the surgical mapping on a touch-screen by
defining the spatial dimensions for ablation using the
transrectal ultrasound images. This also enables preserva-
tion of key anatomical landmarks relevant for both urinary
continence and antegrade ejaculation . Patient infor-
mation is entered manually into the console and then using
foot pedal activation aquablation is commenced with the
ablation being completely automated. Variation of the high
velocity saline flow rate regulates the depth of penetration
while longitudinal and rotational movement of the hand-
piece follow the predefined dimensions of tissue to be
removed. After completion of ablation haemostasis is
performed with a Foley balloon catheter on light traction
or diathermy or low-powered laser if necessary .
[22_TD$DIFF]3.8.2. Clinical outcome
In a prospective, nonrandomised, single-centre trial includ-
ing 15 men with moderate-to-severe LUTS the feasibility
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 7 991