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EUROPEAN UROLOGY 65 (2014) 931–942
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Platinum Priority – Benign Prostatic Obstruction
Editorial by Charalampos Mamoulakis on pp. 943–945 of this issue
180-W XPS GreenLight Laser Vaporisation Versus Transurethral
Resection of the Prostate for the Treatment of Benign Prostatic
Obstruction: 6-Month Safety and Efficacy Results of a European
Multicentre Randomised Trial—The GOLIATH Study
Alexander Bachmann a,*, Andrea Tubaro b, Neil Barber c, Frank d’Ancona d, Gordon Muir e,
Ulrich Witzsch f, Marc-Oliver Grimm g, Joan Benejam h, Jens-Uwe Stolzenburg i, Antony Riddick j,
Sascha Pahernik k, Herman Roelink l, Filip Ameye m, Christian Saussine n, Franck Bruyère o,
Wolfgang Loidl p, Tim Larner q, Nirjan-Kumar Gogoi r, Richard Hindley s, Rolf Muschter t,
Andrew Thorpe u, Nitin Shrotri v, Stuart Graham w, Moritz Hamann x, Kurt Miller y,
Martin Schostak z, Carlos Capitán aa, Helmut Knispel bb, J. Andrew Thomas cc
a
Department of Urology Basel, University Hospital Basel, University Basel, Basel, Switzerland;
b
Department of Urology, Sant’Andrea Hospital, Sapienza
c
d
University of Rome, Rome, Italy; Department of Urology, Frimley Park Hospital, Frimley, Camberley, UK;
Department of Urology, Radboud University
Nijmegen Medical Centre, Nijmegen, The Netherlands; e Department of Urology, King’s College Hospital and King’s Health Partners, London, UK; f Department
of Urology and Paediatric Urology, Krankenhaus Nordwest, Frankfurt, Germany;
h
g
Department of Urology, University Hospital of Jena, Jena, Germany;
i
Department of Urology, Hospital de Manacor, Manacor, Spain; Department of Urology, Universitätsklinikum Leipzig, Leipzig, Germany; j Department of
Urology, Lothian University Hospitals Division, Western General Hospital, Edinburgh, UK;
k
Department of Urology, University Hospital of Heidelberg,
l
Heidelberg, Germany; Department of Urology, Ziekenhuis Groep Twente, Almelo/Hengelo, The Netherlands;
m
Department of Urology, AZ Maria Middelares
n
Gent, Gent, Belgium; Department of Urology, Nouvel Hôpital Civil de Strasbourg, Strasbourg University, Strasbourg, France; o Department of Urology, CHRU
Bretonneau, Tours, Loire Valley, and Université François Rabelais de Tours, PRES Centre-Val de Loire Université, Tours, France;
p
Department of Urology,
q
Krankenhaus der Barmherzigen Schwestern Linz, Linz, Austria; Department of Urology, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK;
r
Department of Urology, Mid Yorkshire NHS Trust, Dewsbury & District Hospital, Dewsbury, UK; s Department of Urology, Basingstoke and North Hampshire
NHS Foundation Trust, Hampshire, UK; t Department of Urology, Diakoniekrankenhaus Rotenburg, Rotenburg, Germany; u Department of Urology, Freeman
Hospital Newcastle, Newcastle upon Tyne, UK; v Department of Urology, Kent and Canterbury Hospital, Kent, UK;
w
Department of Urology, Whipps Cross
x
University Hospital, London, UK; Department of Urology, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany; y Department of Urology,
Charité, Berlin, Germany; z Department of Urology, University Hospital Magdeburg, Magdeburg, Germany;
Fundación Alcorcón, Madrid, Spain;
bb
aa
Department of Urology, Hospital Universitario
Department of Urology, Uro-Forschungs GmbH im St. Hedwig Krankenhaus, Berlin, Germany;
cc
Department of
Urology, ABMU LHB, Princess of Wales Hospital, Bridgend, Wales, UK
Article info
Abstract
Article history:
Accepted October 24, 2013
Published online ahead of
print on November 11, 2013
Background: The comparative outcome with GreenLight (GL) photoselective vaporisation of the prostate and transurethral resection of the prostate (TURP) in men with lower
urinary tract symptoms due to benign prostatic obstruction (BPO) has been questioned.
Objective: The primary objective of the GOLIATH study was to evaluate the noninferiority of 180-W GL XPS (XPS) to TURP for International Prostate Symptom Score (IPSS)
and maximum flow rate (Qmax) at 6 mo and the proportion of patients who were
complication free.
* Corresponding author. Department of Urology, University Hospital Basel, University of Basel,
Spitalstr. 21, 4031 Basel, Switzerland. Tel. +41 6126 57284; Fax: +41 6126 57232.
E-mail address: [email protected] (A. Bachmann).
0302-2838/$ – see back matter # 2013 Published by Elsevier B.V. on behalf of European Association of Urology.
http://dx.doi.org/10.1016/j.eururo.2013.10.040
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EUROPEAN UROLOGY 65 (2014) 931–942
Keywords:
Benign prostatic obstruction (BPO)
GreenLight XPS 180-W laser
Photoselective vaporisation of
the prostate (PVP)
TURP
Safety
Efficacy
Clavien-Dindo classification
Adverse events
Transurethral surgery
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then be attributed automatically.
1.
Design, setting, and participants: Prospective randomised controlled trial at 29 centres
in 9 European countries involving 281 patients with BPO.
Intervention: 180-W GL XPS system or TURP.
Outcome measurements and statistical analysis: Measurements used were IPSS, Qmax,
prostate volume (PV), postvoid residual (PVR) and complications, perioperative parameters, and reintervention rates. Noninferiority was evaluated using one-sided tests at the
2.5% level of significance. The statistical significance of other comparisons was assessed
at the (two-sided) 5% level.
Results and limitations: The study demonstrated the noninferiority of XPS to TURP for
IPSS, Qmax, and complication-free proportion. PV and PVR were comparable between
groups. Time until stable health status, length of catheterisation, and length of hospital
stay were superior with XPS ( p < 0.001). Early reintervention rate within 30 d was three
times higher after TURP ( p = 0.025); however, the overall postoperative reintervention
rates were not significantly different between treatment arms. A limitation was the short
follow-up.
Conclusions: XPS was shown to be noninferior (comparable) to TURP in terms of IPSS,
Qmax, and proportion of patients free of complications. XPS results in a lower rate of early
reinterventions but has a similar rate after 6 mo.
Trial registration: ClinicalTrials.gov, identifier NCT01218672.
# 2013 Published by Elsevier B.V. on behalf of European Association of Urology.
Introduction
Benign prostatic obstruction (BPO) is one of the most
commonly diagnosed conditions of the male genitourinary
tract and worldwide results in 1.2 million surgical
procedures per year. Transurethral resection of the prostate
(TURP) is considered the reference treatment for lower
urinary tract symptoms (LUTS) due to BPO [1]. However, the
safety profile of this procedure remains questionable,
especially in patients with large prostate volumes (PVs)
[2]. Over the last decade, there have been efforts to identify
new technologies that can replicate the efficacy achieved by
monopolar TURP but with an improved safety profile [3]. As
an alternative to TURP, GreenLight (GL) laser photoselective
vaporisation of the prostate (PVP) has evolved over the past
few years to the 180-W GL XPS (XPS) laser system using the
MoXy fibre [4].
Recently, published meta-analyses suggest that former
GL systems are similar to TURP with respect to improvements in International Prostate Symptom Score (IPSS) and
maximum flow rate (Qmax) plus improved complication
rates [5–7]. However, GL PVP has been criticised for limited
reduction of PV compared with TURP, the cost of the
equipment, and prolonged storage symptoms [8]. Preliminary data suggest superiority of the XPS over previous GL
systems in terms of efficacy while maintaining the known
safety characteristics [9,10]. The GOLIATH study was
conducted to compare the safety of the XPS GL system
with TURP in patients with BPO.
2.
Patients and methods
2.1.
Patients
The trial was conducted at 29 centres in nine European
countries. Table 1 provides the full inclusion and exclusion
criteria for the trial. All sites obtained ethics committee and
research and development committee approvals for the trial
prior to commencement.
2.2.
Study design
The study is an open-label, prospective, multicentre
randomised controlled trial with 2-yr follow- up comparing
outcomes with TURP and XPS techniques. Figure 1 shows
the design of the study including randomisation, treatment,
and follow-up of patients.
The primary outcome is the IPSS at 6 mo. A number of
secondary outcomes were assessed including Qmax, freedom
from complications during the first 180 d postprocedure,
postvoid residual (PVR), PV via transrectal ultrasound,
prostate-specific antigen (PSA), and patient-reported measures regarding general health, urinary incontinence, sexual
function, and satisfaction with the procedure. Variables
associated with return to patient health included length of
catheterisation, length of hospitalisation, and time until
stable health.
An independent external clinical events committee of
three board-certified academic urologists adjudicated adverse events (AEs) blinded to treatment. AEs were classified
using (1) a modified Clavien-Dindo classification [11], (2)
relatedness to the treatment, and (3) whether the event met
the definition of a complication (Supplemental Fig. 1). A
complication was defined in the study protocol as an AE
related to the treatment that involved prolonged or additional
hospitalisation or surgical or invasive intervention excluding
medications and urinary retention with short-term catheterisation (ie, catheterisation that lasted <7 d) [12].
2.3.
Surgical procedures
All surgeons were licensed urologists trained and experienced with TURP; each site was limited to two surgeons.
EUROPEAN UROLOGY 65 (2014) 931–942
Table 1 – Patient selection criteria
Inclusion criteria
Subject has provided informed consent and agrees to attend all study
visits.
Subject has diagnosis of lower urinary tract symptoms due to benign
prostatic enlargement causing bladder outlet obstruction.
Subject is willing to be randomised.
Subject is able to complete self-administered questionnaires.
The subject is a surgical candidate for either the XPS or the TURP
procedure and may be randomised into either arm.
Subject is 40–80 yr of age.
Subject has an IPSS score 12 measured at the baseline visit.
Subject has medical record documentation of Qmax <15 ml/s.
Subject has medical record documentation of a prostate volume
100 ml by TRUS.
Subject is classified ASA I, II, or III.
Subject has a serum creatinine within the normal range for the study
centre.
Exclusion criteria
Subject has a life expectancy <2 yr.
Subject is currently enrolled in or plans to enrol in any concurrent
drug or device study.
Subject has an active infection (eg, urinary tract infection or prostatitis).
Subject has a diagnosis of or has received treatment for chronic
prostatitis or chronic pelvic pain syndrome (eg, nonbacterial chronic
prostatitis).
Subject has been diagnosed with a urethral stricture or bladder neck
contracture within the last 180 d.
Subject has been diagnosed with two or more urethral strictures
and/or bladder neck contractures within 5 yr.
Subject has a diagnosis of lichen sclerosus.
Subject has a neurogenic bladder or other neurologic disorder that affects
bladder function.
Subject has a diagnosis of polyneuropathy (eg, diabetic).
Subject has history of lower urinary tract surgery.
Subject has diagnosis of stress urinary incontinence that requires
treatment or daily pad or device use.
Subject has a history of intermittent self-catheterisation.
Subject has been catheterised or has a PVR >400 ml in the 14 d prior
to the surgical procedure.
Subject has current diagnosis of bladder stones.
Subject has diagnosis of prostate cancer.
Subject has a history of CIS, TaG2, TaG3, or any T1 stage bladder cancer.
Subject has damage to external urinary sphincter.
Subject has a medical contraindication for undergoing either TURP
or XPS surgery.
Subject has a disorder of the coagulation cascade (eg, haemophilia) or
disorders that affect platelet count or function (eg, von Willebrand
disease) that would put the subject at risk for intraoperative or
postoperative bleeding.
Subject is unable to discontinue anticoagulant and antiplatelet therapy
preoperatively (3–5 d) except for low-dose aspirin (eg, 100 mg).
Subject has had an acute myocardial infarction, open heart surgery, or
cardiac arrest <180 d prior to the date of informed consent.
Subject is immunocompromised (eg, organ transplant, leukaemia).
ASA = American Society of Anaesthesiologists; CIS = carcinoma in situ;
IPSS = International Prostate Symptom Score; PVR = postvoid residual;
Q max = maximum flow rate; TRUS = transrectal ultrasound; TURP =
transurethral resection of the prostate; XPS = 180-W GreenLight XPS.
Only the principal investigators were allowed to perform
both techniques. Prior surgical experience with XPS varied
among the group from <10 cases to >500 cases. The surgical
technique for XPS was standardised according to previously
published recommendations [13] and updated to the
specification for using the XPS laser device including MoXy
fibre [10]. Each surgeon was evaluated for adherence to the
standard technique before being allowed to randomise
patients.
2.4.
933
Randomisation and statistical analysis
Randomisation was performed after checking the patient’s
eligibility for the study. The patients were assigned to
treatments in a 1:1 ratio within each clinical site by a
permuted-block randomisation schedule with mixed-block
sizes of two and four. The patients were assigned in order of
enrolment using sequentially numbered and sealed envelopes that contained the random treatment assignment.
Blinding was not attempted.
The study design provided 80% power to demonstrate
noninferiority of XPS for each of IPSS, Qmax, and complication-free proportion. For the primary outcome of IPSS, it was
estimated that at least 113 men were needed in each
treatment arm to demonstrate XPS noninferiority, using a
noninferiority margin of three points [14]. With respect to
Qmax, a noninferiority margin of 5 ml/s was used, and for
the complication-free proportion, a noninferiority margin of
5%. Noninferiority was evaluated using one-sided tests at
the 2.5% level of significance. The two-sample t test was
used for the IPSS and Qmax, whereas the FarringtonManning test was used for the complication-free proportion. Further details are shown in the Supplementary data.
3.
Results
3.1.
Study population
Between April 2011 and September 2012, a total of 291
patients were enrolled, of whom 10 were deemed ineligible
prior to randomisation (Fig. 1). The randomisation assigned
139 patients to XPS and 142 to TURP. Postrandomisation,
seven patients were determined to be ineligible and were not
treated. Per protocol, 136 and 133 patients underwent XPS or
TURP, respectively, and 265 patients (99%) were available at
6-mo follow-up; demographic and clinical characteristics of
the treated patients are shown in Table 2. Mean follow-up
of the entire cohort was 12.3 mo (standard deviation [SD]:
3.6 mo; range: 0.07–23.9 mo). For the XPS arm, follow-up was
12.4 mo (SD: 3.6 mo; range: 0.7–21.5 mo); for the TURP arm,
follow-up was 12.2 mo (SD: 3.6 mo; range: 5.1–23.9 mo).
3.2.
Outcomes
Table 3 shows the primary outcomes. The mean IPSS at 6 mo
was not significantly different between XPS and TURP, and
the criterion for XPS noninferiority was met ( p = 0.002). The
results for the per protocol and the modified intention-totreat groups were identical. A consistent and comparable
improvement in IPSS was observed over time in the two
arms (Fig. 2a).
The Qmax at 6 mo was not statistically different between
arms, and the criterion for XPS noninferiority was met
( p = 0.002) (Table 3). The results from the modified
intention-to-treat analysis were similar (mean difference;
1.1; 95% confidence interval, 3.9 to 1.7). Improvement in
Qmax over time was comparable in the two arms (Fig. 2c).
The proportion of patients who were complication free
during the first 180 d was comparable after XPS (87.3%)
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EUROPEAN UROLOGY 65 (2014) 931–942
[(Fig._1)TD$IG]
291 Enrolled
10 Determined ineligible
281 Underwent randomisaon
139 Were assigned to XPS
142 Were assigned to TURP
3 Were not treated
1 Determined ineligible
1 Was lost to follow-up
1 Declined treatment
136 Were assigned to XPS
135 Underwent XPS per assignment
1 Underwent TURP owing to fibre error
9 Were not treated
6 Determined ineligible
3 Declined treatment
133 Were assigned to TURP
132 Underwent TURP per assignment
1 Underwent XPS owing to miscommunicaon
1 Declined to connue
135 Aended 3-wk visit
131 Aended 3-wk visit
2 Missed visit
132 Aended 3-mo visit
3 Missed visit
132 Aended 3-mo visit
1 Missed visit
1 Was lost to follow-up
2 Declined to connue
134 Aended 6-mo visit
131 Aended 6-mo visit
Fig. 1 – Design of the GOLIATH study including randomisation, treatment, and follow-up of patients.
TURP = transurethral resection of the prostate; XPS = 180-W GreenLight XPS.
and TURP (83.2%), and the criterion for XPS noninferiority
was met ( p = 0.019) (Table 3). The results of the per
protocol and modified intention-to-treat analyses were
identical. Overall, it was observed that the complicationfree rate was higher after XPS during the follow-up period
(Fig. 3).
3.3.
Perioperative results
Table 4 summarises the operative characteristics. The time
spent in the recovery room after surgery was comparable
with the two procedures; however, XPS was found to be
superior to TURP in terms of shorter length of catheterisation, shorter time until stable health, and shorter length of
hospital stay ( p < 0.001; Table 5). Prostate cancer was
detected in 5 of the 133 patients (3.8%) based on pathologic
evaluation of TURP chips.
3.4.
Functional results and efficiency parameters
The mean values for IPSS quality-of-life score, PVR, and PV
all decreased substantially over time in both arms and were
comparable within the 6-mo follow-up (Fig. 2b–2e). The
reduction in PV at 6 mo was comparable between groups
( p = 0.079; Fig. 2e). The absolute PSA values were different
at 6 mo ( p = 0.007; Fig. 2f). The mean (SD) percentage
reductions from baseline also differed (XPS 34.7% [56.4]
and TURP 43.2% [57.9]; p = 0.025) (Fig. 2f).
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EUROPEAN UROLOGY 65 (2014) 931–942
Table 2 – Baseline characteristics of treated patients
Variable
Age, yr
BMI, kg/m
2
Current anticoagulant use up to surgery, no. (%)
Aspirin up to surgery, 100 mg, no. (%)
Use of 5-ARI up to surgery, no. (%)
Charlson Comorbidity Index
Duration of BPO, yr
IPSS
Qmax, ml/s
PVR, ml
PSA, ng/ml
TRUS prostate volume, ml
XPS
TURP
n = 136
65.9 (6.8)
(44.0, 66.0, 80.0)
n = 136
27.2 (3.9)
(18.3, 26.8, 39.8)
n = 134
5 (3.7)
n = 134
28 (20.9)
n = 134
36 (26.9)
n = 136
0.4 (0.6)
(0.0, 0.0, 2.0)
n = 135
6.6 (6.2)
(0.1, 4.3, 37.1)
n = 136
21.2 (5.9)
(8.0, 21.0, 35.0)
n = 121
9.5 (3.0)
(3.0, 9.5, 16.1)
n = 131
110.1 (88.5)
(0.0, 91.9, 361.0)
n = 136
2.7 (2.1)
(0.1, 2.1, 9.6)
n = 136
48.6 (19.2)
(17.3, 45.4, 105.0)
n = 133
65.4 (6.6)
(46.0, 66.0, 80.0)
n = 133
27.5 (3.8)
(17.0, 27.2, 49.4)
n = 130
9 (6.9)
n = 130
23 (17.7)
n = 130
45 (34.6)
n = 133
0.2 (0.5)
(0.0, 0.0, 3.0)
n = 133
5.0 (4.6)
(0.1, 3.4, 20.2)
n = 132
21.7 (6.4)
(6.0, 21.5, 35.0)
n = 125
9.9 (3.5)
(2.8, 9.8, 20.7)
n = 128
109.8 (103.9)
(0.0, 75.0, 465.0)
n = 133
2.6 (2.1)
(0.1, 2.2, 10.3)
n = 133
46.2 (19.1)
(16.6, 42.5, 98.7)
p value*
0.519
0.532
0.282
0.536
0.184
0.024
0.018
0.507
0.266
0.976
0.800
0.301
5-ARI = 5a-reductase inhibitor; BMI = body mass index; BPO = benign prostatic obstruction; IPSS = International Prostate Symptom Score; Qmax = maximum
flow rate; PSA = prostate-specific antigen; PVR = postvoid residual; TRUS = transrectal ultrasound; TURP = transurethral resection of the prostate; XPS = 180-W
GreenLight XPS.
Values shown represent mean (standard deviation) (minimum, median, and maximum), unless otherwise noted.
*
The p value reported is for statistical test of difference between groups.
Table 3 – Primary and secondary outcome: summary of International Prostate Symptom Score, maximum flow rate, and complication-free
status
End point
IPSS at 6 mo
Qmax at 6 mo
Complication free during 180 d
XPS
n = 136
TURP
n = 133
Difference (95% CI)*
6.8 (5.2)
23.3 (10.1)
87.3% (117/134)
5.6 (4.9)
24.2 (11.4)
83.2% (109/131)
1.2 (0.0 to 2.4)
0.9 (3.7 to 1.9)
4.1% (4.5% to 12.7%)
CI = confidence interval; IPSS = International Prostate Symptom Score; Qmax = maximum flow rate; TURP = transurethral resection of the prostate; XPS = 180-W
GreenLight XPS.
Results presented as mean (standard deviation) or percentage (no. complication free/no. completed 6-mo follow-up).
*
Difference refers to mean difference or difference between proportions (XPS minus TURP).
3.5.
Adverse events
All AEs classified as treatment related by the clinical events
committee are summarised in Table 6 and Supplemental
Table 1. Overall, 47.8% of XPS patients and 53.4% of TURP
patients were free of treatment-related AEs; 30.9% of XPS
patients and 25.6% of TURP patients had only one
treatment-related AE; 21.3% of XPS patients and 21.1%
of TURP patients had two or more treatment-related AEs
( p = 0.592; Cochran-Armitage trend test). There were 117
AEs documented in 71 patients with XPS (n = 136) and 98
AEs in 62 patients after TURP ( p = 0.394). The most common
grade 1 AEs with either treatment were storage symptoms,
urinary incontinence, and bleeding. The most common
grade 2 AE was urinary tract infection, documented in 14.7%
after XPS and 8.3% after TURP. Fewer grade 3 AEs were
observed after XPS compared with TURP, with 19 AEs in
17 patients (12.5%) versus 29 AEs in 26 patients (19.5%)
(Table 6; Fig. 4); the most frequent were bleeding, retention,
and urethral strictures. Grade 3 bleeding AEs were less
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[(Fig._2)TD$IG]
EUROPEAN UROLOGY 65 (2014) 931–942
Fig. 2 – Outcome following treatment with the 180-W XPS GreenLight photoselective vaporisation of the prostate (PVP) or transurethral resection of the
prostate (TURP) measured in terms of (a) International Prostate Symptom Score (IPSS), (b) IPSS quality-of-life (QoL) index, (c) maximum flow rate (Qmax),
(d) postvoid residual (PVR), (e) prostate volume reduction at 6 mo, and (f) change in prostate-specific antigen (PSA) at 6 mo. Values plotted are means and
associated 95% confidence intervals. The p values presented are for a two-sided test of a statistical difference between treatment arms.
TRUS = transrectal ultrasound.
common after XPS (2.9%) compared with TURP (6.8%;
p = 0.165). There were two blood transfusions in one patient
after TURP. The proportion of patients with storage symptoms
(dysuric or irritative symptoms) was comparable after XPS
and TURP, considering all grades ( p = 0.651; Table 6).
Urinary incontinence was observed in 11.0% of XPS
patients and 3.0% of TURP patients ( p = 0.015; Table 7,
Fig. 4). All of the TURP cases and 12 of the 16 XPS cases were
of mild severity (easily tolerated with noninvasive inter-
vention) as classified by the clinical centre. Moderate
urinary incontinence, defined as causing interference with
usual activity with minimal intervention or tolerated but
requiring intervention, was reported in three XPS patients
and no TURP patients ( p = 0.247).
AEs requiring a surgical or other invasive intervention
were classified in 13 patients (9.6%) after XPS and 18
patients (13.5%) after TURP ( p = 0.343; Table 8). The
proportion of patients requiring an early reintervention
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EUROPEAN UROLOGY 65 (2014) 931–942
Table 4 – Summary of operating parameters
Parameter
XPS (n = 136)
Anaesthesia, no. (%)
General
Spinal
Local
Regional
Other
Procedure time, min
Lasing time, min
(n = 135)
Resection time, min
(n = 133)
Total energy delivered, kJ
(n = 136)
Resection weight, g
(n = 132)
Maximum power used, W
TURP (n = 133)
79 (58.1)
57 (41.9)
1 (0.7)
0 (0.0)
1 (0.7)
n = 133
49.6 (21.8)
(15.0, 46.0, 160.0)
44.5 (21.2)
(14.0, 41.0, 144.0)
NA
76 (57.1)
54 (40.6)
0 (0.0)
3 (2.3)
0 (0.0)
n = 133
39.3 (18.5)
(0.0, 36.0, 110.0)
NA
TURP loop type, no. (%)
No. fibres/loops used, no. (%)
1
2
3
125 (91.9)
11 (8.1)
0 (0)
0.902
0.902
1.000
0.120
1.000
<0.001
34.8 (17.0)
(10.0, 33.0, 103.0)
NA
232.5 (129.5)
(43.6, 206.6, 789.6)
NA
n = 136
165.9 (22.4)
(80.0, 180.0, 180.0)
–
p value*
19.1 (13.3)
(2.0, 15.9, 80.0)
n = 128
216.2 (65.2)
(100.0, 200.0, 320.0)
Monopolar
Bipolar
78 (58.6%)
55 (41.4)
69 (88.5)
8 (10.3)
1 (1.3)
48 (87.3)
7 (12.7)
0 (0.0)
NA = not applicable; TURP = transurethral resection of the prostate; XPS = 180-W GreenLight XPS.
Values shown represent mean (standard deviation) (minimum, median, maximum), unless otherwise noted.
*
The p value reported is for statistical test of difference between groups, if available.
Table 5 – Recovery parameters following treatment with 180-W GreenLight XPS or transurethral resection of the prostate
*
Recovery time, h
Length of catheterisation, hy
Time to stable health status, hz
Length of hospital stay, h
XPS
TURP
n = 131
2.2 (3.5)
(0.0, 1.2, 25.9)
n = 128
40.8 (71.5)
(0.0, 22.0, 624.8)
n = 136
37.3 (42.2)
(2.6, 26.0, 403.8)
n = 134
65.5 (63.3)
(5.5, 49.3, 524.6)
n = 129
2.9 (6.1)
(0.0, 1.3, 43.8)
n = 124
59.5 (40.6)
(7.8, 46.7, 286.1)
n = 133
63.5 (39.1)
(2.7, 52.8, 287.3)
n = 130
96.9 (62.0)
(6.0, 78.2, 357.3)
p value
0.328
<0.001
<0.001
<0.001
TURP = transurethral resection of the prostate; XPS = 180-W GreenLight XPS.
Results given as mean (standard deviation) (minimum, median, maximum).
*
Recovery time: time of entry into the recovery room up to the time of exit from recovery room.
y
Length of catheterisation: time catheter inserted up to catheter is removed. Catheter removal time is recorded as the time when the catheter is removed
and followed by a successful voiding trial.
z
Time to stable health status: time from entering the recovery room until the earlier of discharge from the medical facility or the first successful voiding
trial without an ongoing treatment-related adverse event.
(30 d) was significantly higher after TURP than XPS (9.8%
vs 2.9%; p = 0.025); reintervention rates up to 180 d were
comparable in the two groups (Table 8).
ejaculation (a sequelae event) occurred in 88 PVP and 84
TURP patients.
4.
3.6.
Discussion
Other
There were two prostate perforations and two urethral
injuries in the XPS treatment arm. One XPS patient
experienced reobstruction from the prostate. Retrograde
The GOLIATH study is the largest prospective randomised
trial to date comparing TURP with laser prostatectomy
[4,6,15,16]. Besides the comparison of techniques, the
GOLIATH study provides an update of excellent TURP data
938
[(Fig._3)TD$IG]
EUROPEAN UROLOGY 65 (2014) 931–942
Fig. 3 – Kaplan-Meier estimates for proportion of patients free of complications following treatment with 180-W XPS GreenLight photoselective
vaporisation of the prostate or transurethral resection of the prostate (TURP): (a) within 30 d; (b) within 180 d.
in Europe [1–3,17]. The study was designed to evaluate the
noninferiority of GL XPS to high-quality TURP outcomes,
achieved by including only experienced TURP surgeons as
investigators.
The study is also the first one powered to compare
safety and efficacy parameters with the two forms of
treatment. The primary end points were met, and results
demonstrate noninferiority of XPS using the MoXy fibre
to TURP with regard to IPSS, Qmax, and complication-free
rate after 6 mo (Table 3). Analysis of secondary end points
demonstrated that length of catheterisation, time until
stable health, and length of stay were superior after XPS
compared with TURP (Table 5).
Historically, GL has been viewed as less efficacious
compared with TURP [5,17–19]. The recent XPS laser
system represents a significant improvement over previous
systems in terms of efficacy while maintaining the known
safety characteristics of previous GL systems [9,10]. Given
the rapid progression of the GL technology over the last
decade, there are limited long-term studies, and the current
literature largely reports data from early 80-W and 120-W
systems [6,7].
Monopolar TURP removes about 30–50% of the preoperatively measured PV [20]. In the TURP arm of the GOLIATH
study, the mean (SD) PV was 46.2 (19.1) ml; 19.1 (13.3) g of
tissue was resected (41.4%). A similar prostate size reduction
was observed in the XPS arm, using on average 232.5 kJ
energy per procedure. The increase in power to 180 W and a
more efficient MoXy fibre has led to a faster and more
efficient energy transfer that improves tissue removal [9].
It has been shown that PSA value is strongly correlated
with total PV, and TRUS-determined adenoma volume
correlates well with the tissue resected by TURP [21]. PSA
and TRUS PV measurement can be used as surrogate
parameters, although there are limitations due to other
factors influencing the increase and decrease. In the current
study, PSA reduction was statistically higher after TURP, but
PV measurements after both procedures were not different.
In the short term, the efficiency of XPS was comparable with
TURP. But the crucial question will be the long-term
functional results, reintervention rate, and patient satisfaction with longer follow-up.
AE rates across the modified Clavien-Dindo grades were
similar between treatment groups. However, there were
fewer grade 3 bleeding events in the XPS group, consistent
with the hypothesis that severe bleeding should be seen less
frequently with this treatment compared with TURP
[6,7,22–27]. With previous laser systems, the reintervention rate was higher compared with TURP, mainly due to the
inefficiency of immediate tissue removal [17]. The GOLIATH
study provides evidence for the first time that the overall
portion of patients free of any AE was comparable between
XPS and TURP (Table 3). The treatment arms were similar
with respect to reintervention; however, the early reintervention rate within 30 d of treatment was three times
higher after TURP (Table 8).
Previous reports of long-lasting dysuric complications
(storage symptoms) range from 2.4% to 68.2% after
holmium laser enucleation of the prostate (HoLEP), 7.6–
14.8% after 80-W/120-W GL PVP, and 10.7–13% after
thulium yttrium-aluminium-garnet laser prostatectomy.
The lack of a standardised definition for dysuria makes it
difficult to compare results from previously reported
studies. The rate of storage symptoms, which have been
rated blinded to the treatment by a study-independent
expert group, was comparable in the two arms of the
GOLIATH study (Table 6; Fig. 4). This observation is of
interest considering previous reports that GL laser vaporisation results in a higher rate of prolonged urgency,
dysuria, and overall storage symptoms compared with what
can be expected with TURP [5]. Also, the sloughing of
prostatic tissue leading to postoperative obstructive voiding
was not observed after XPS in the current study.
Previously reported rates of urinary incontinence are up
to 2.2% in patients undergoing TURP, 1.2% for earlier
generations of PVP, and 10.7% for diode laser [5,28]. After
HoLEP, significant stress urinary incontinence is reported in
12.5% of patients within 6 mo and 3.4% at 6- to 12-mo
939
EUROPEAN UROLOGY 65 (2014) 931–942
Table 6 – Treatment-related adverse events (AEs) and number of patients with AEs by the modified Clavien-Dindo classification [11]
AEs
XPS
(n = 136)
No. AEs
Clavien-Dindo grade 1
Bleeding
Urinary tract infection
Irritative symptoms/pain/discomfort
Stricture (meatal, urethral, bladder neck)
Urinary incontinence*
Urinary retention**
Other
Total***
Clavien-Dindo grade 2
Bleeding
Urinary tract infection
Irritative symptoms/pain/discomfort
Urinary incontinence
Other
Total**
Clavien-Dindo grade 3a
Bleeding
Stricture (meatal, urethral, bladder neck)
Urinary retention*
Total**
Clavien-Dindo grade 3b
Bleeding
Stricture (meatal, urethral, bladder neck)
Urinary retention*
Total**
Total overall Clavien-Dindo grades**
TURP
(n = 133)
No. patients (%)
No. AEs
p value
No. patients (%)
9
6
25
1
12
8
5
66
9
5
22
1
12
8
5
46
(6.6)
(3.7)
(16.2)
(0.7)
(8.8)
(5.9)
(3.7)
(33.8)
9
2
24
0
4
3
6
48
9
2
24
0
4
3
6
39
(6.8)
(1.5)
(18.0)
(0.0)
(3.0)
(2.3)
(4.5)
(29.3)
1.000
0.447
0.747
1.000
0.068
0.217
0.768
0.435
3
20
4
4
1
32
3
20
4
3
1
30
(2.2)
(14.7)
(2.9)
(2.2)
(0.7)
(22.1)
2
13
5
0
1
21
2
11
5
0
1
19
(1.5)
(8.3)
(3.8)
(0.0)
(0.8)
(14.3)
1.000
0.126
0.747
0.247
1.000
0.115
2
0
7
9
2
0
7
9
(1.5)
(0.0)
(5.1)
(6.6)
4
2
10
16
4
2
9
14
(3.0)
(1.5)
(6.8)
(10.5)
0.444
0.244
0.615
0.282
2
6
2
10
117
2
6
2
10
71
(1.5)
(4.4)
(1.5)
(7.4)
(52.2)
6
6
1
13
98
6
6
1
13
62
(4.5)
(4.5)
(0.8)
(9.8)
(46.6)
0.169
1.000
1.000
0.519
0.394
AE = adverse event; TURP = transurethral resection of the prostate; XPS = 180-W GreenLight XPS.
Based on information available at the time of the prespecified end point for the trial (6 mo), the independent AE committee did not assign a Clavien-Dindo grade
for five events because these pateints did not receive treatment/intervention for their symptoms. In this analysis, these events (three photoselective vaporisations
of the prostate and two TURPs) were assigned preliminary Clavien-Dindo grade 1.
**
Per protocol, 31 urinary retentions were observed. Thirteen events did not require hospitalisation. Nine complications required hospital readmission; they are
broken down as follows: XPS: grade 1, n = 2; grade 3, n = 2; TURP: grade 1, n = 1; grade 3, n = 4. Nine complications resulted in prolonged hospitalisation, as
follows: XPS: grade 1, n = 5; grade 3, n = 4; TURP: grade 1, n = 2; grade 3, n = 7.
***
The total number of patients with at least one event in the grade will not equal the sum of number of patients in each category when a patient has an event in
more than one category within the grade.
*
Table 7 – Urinary incontinence events by severity
Treatment received
XPS (n = 136)
Urinary
incontinence
Severity: mild
- De novo stress
- De novo urge
Total
Severity: moderate
- De novo stress
- De novo urge
Total
Entire cohort
TURP (n = 133)
No.
events
No. subjects
(%)
Resolved
90 d
Resolved
>90 d
No.
events
No. subjects
(%)
Resolved
90 d
Resolved
>90 d
8
4
12
8 (5.9)
4 (2.9)
12 (8.8)
4
2
6
2
1
3
2
2
4
2 (1.5)
2 (1.5)
4 (3.0)
0
1
1
0
0
0
3
1
4
16
3
1
3
15
0
0
0
6
2
1
3
6
0
0
0
4
0
0
0
4
0
0
0
1
0
0
0
0
(2.2)
(0.7)
(2.2)
(11.0)
(0.0)
(0.0)
(0.0)
(3.0)
TURP = transurethral resection of the prostate; XPS = 180-W GreenLight XPS.
Incontinence was mild in most cases, and three subjects (2.2%) in the XPS group experienced moderate incontinence. No subjects in the TURP group
experienced moderate incontinence. Mild incontinence was reported in 12 XPS patients (8.8%) and 4 TURP patients (3.0%) ( p = 0.069). There was no statistical
difference in the incidence of moderate urinary incontinence between the two groups ( p = 0.247).
follow-up [29]. In the current study, urinary incontinence
was observed more frequently after XPS, but no severe cases
were observed, and moderate cases were observed in only
three patients (Table 7).
It is suspected that GL vaporisation results in a missed
opportunity to diagnose prostate cancer. Historically, incidental prostate cancer was diagnosed in 4–22% of TURP
specimens [30]. In a recent study of adenoma enucleations,
940
EUROPEAN UROLOGY 65 (2014) 931–942
[(Fig._4)TD$IG]
21.8
XPS (n = 136)
19.1
20.0
19.5
TURP (n = 133)
16.2
14.3
15.0
12.5
11.8
11.0
10.0
11.0
9.8
9.0
7.5
6.8
5.9
6.0
4.4
5.0
2.9
o
n
(g
ra
de
III
)
III
)
te
de
in
ad
gic
bl
lo
al,
io
re
th
r
Su
rg
St
ica
le
nd
os
co
pi
co
rr
ur
e(
m
ea
ta
l, u
ric
t
p = 0.135
rv
rn
et
en
o
n
yr
ar
Ur
in
pt
ym
es
v
ita
Ir r
p = 0.594
ec
k)
(g
ra
de
II)
ad
eI
ng
(g
r
n
on
ar
yi
nc
yr
p = 0.633
(g
ra
de
III
)
p = 0.165
en
ce
p = 0.015
et
en
o
n
rt
fo
s/
om
Ur
in
ar
pa
in
yt
ra
/d
ct
i
isc
nf
e
om
ng
di
ee
Bl
Ur
in
ar
p = 0.842
Bl
ee
di
p = 0.651
Ur
in
p = 0.098
c
on
p = 0.589
0.0
ad
3.0
en
Percentage of paents (%)
25.0
Fig. 4 – Incidence of adverse events (grouped). Results are shown as numbers of patients in relation to the total number of patients treated per arm as
percentages (per protocol). The p values are provided. Differences between 180-W XPS GreenLight photoselective vaporisation of the prostate (XPS) and
transurethral resection of the prostate (TURP) in each adverse event category were not statistically different except for urinary incontinence.
Table 8 – Rate of reinterventions (n = 31) following treatment with the 180-W GreenLight XPS or transurethral resection of the prostate at
early (=30 d) and intermediate (>30 d) follow-up
Onset of AE
AE
Early (30 d), no. (%)
Urinary retention
Bleeding
Bladder neck stricture
Delayed (>30–180 d), no. (%)
Urinary retention
Bleeding
Bladder neck stricture
Urethral/Meatal stricture
Total* (%)
XPS
(n = 136)
TURP
(n = 133)
p value*
4 (2.9)
n=3
n=1
0
9 (6.6)
n=1
n=2
n=3
n=3
13 (9.6)
13 (9.8)
n=6
n=5
n=2
5 (3.8)
0
0
n=1
n=4
18 (13.5)
0.025
0.412
0.343
AE = adverse event; TURP = transurethral resection of the prostate; XPS = 180-W GreenLight XPS.
Rate is number of patients and the related AE resulting in a reintervention. A reintervention was based on the following definition: A subject is considered to
have had a reintervention based on a retreatment form or if he had an adverse event with an intervention that was invasive or surgical (per the Adverse Event
Adjudication Committee).
*
The p value reported is for statistical test of difference between groups.
prostate cancer was diagnosed in 3.1% of pathologic specimens [31]. The findings in the GOLIATH study are in line
with previous results; prostate cancer was diagnosed in
only five patients (3.8%) based on resected tissue. Gleason
scores were 3 + 3 in four cases and 3 + 4 in one case. Due
to comparable baseline patient characteristics, it can be
assumed that the risk of delayed prostate cancer diagnosis
with XPS remains low in the era of PSA and active
surveillance strategies. Of note, the GOLIATH study was
not designed to study this aspect in depth.
The limitations to the study are that the prespecified
primary end point of IPSS at 6 mo represents relatively short
follow-up. Nevertheless, most procedure-related AEs
should occur within this time range, which provides
confidence for the safety assessment. The study design
allows extended patient follow-up that should provide
confirmation of the durability of these results. Also,
the independent Adverse Event Adjudication Committee
graded AEs/complications according to their medical
assessment, and at times the definition of a complication
EUROPEAN UROLOGY 65 (2014) 931–942
was not consistent with the Clavien-Dindo classification.
Erectile dysfunction was not evaluated at 6 mo; 12-mo data
will be reported at a later date.
941
study are pleased to thank all the centre PIs, surgeons, attending
colleagues, study nurses, nurses, study monitors, and supporters of
GOLIATH. Special thanks to Prof. C. Chapple, Prof. M. Marberger, and Prof.
O. Reich for their function as the independent Adverse Event Adjunction
5.
Conclusions
This study is the first to demonstrate noninferiority of XPS
to TURP in terms of short- term efficiency. In men
experiencing LUTS due to BPO, GL XPS was comparable
with TURP in terms of IPSS, Qmax, overall complication-free
rate, prostatic tissue removal, and PV reduction. XPS was
superior to TURP in terms of shorter catheterisation times,
shorter hospital stay, and more rapid return to stable
health status. Storage symptoms were comparable after
XPS and TURP. The early postoperative reintervention rate
was three times higher after TURP compared with XPS;
however, overall postoperative reintervention rates were
not significantly different between treatment arms.
Committee. Both joint PIs thank especially the AMS GOLIATH team for
their excellent and consistent administrative and statistical support and
finally the study management.
Appendix A. Supplementary data
Supplementary data associated with this article can be
found, in the online version, at http://dx.doi.org/10.1016/j.
eururo.2013.10.040.
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