MT217 The TURis system for transurethral resection of the prostate
National Institute for Health and Care Excellence
Medical Technologies Evaluation Programme
MT217 The TURis system for transurethral resection of the prostate
Consultation Comments table
MTAC date: 18 December 2014
There were 12 consultation comments from 4 consultees (1 manufacturer, 1 external assessment centre, 1 specialist society and 1 patient
organisation. The comments are reproduced in full.
Com.
no.
Consultee number
and organisation
Sec. no.
Comments
1
1. Olympus
Recommendation Please could we change the formatting from
TransUrethral Resection in saline to transurethral
1.1
resection in saline.
2
1. Olympus
Technology
2.2
3
1. Olympus
Cost evidence
5.13
Response
Thank you for your comment. The
formatting of transurethral resection in
saline has been changed throughout the
MTCD.
The TURis system consists of an Olympus generator; a
Thank you for your comment. Section 2.2
resectoscope, which incorporates the TURis active
of the guidance has been changed to
working element and electrode, a telescope, an inner and include the correction.
outer sheath, a light guide cable, and a saline cable
(which acts an irrigation channel). The sentence “(which
acts as an irrigation channel)” needs to be removed, this
is incorrect and out of context.
Thank you for your comment. Section 5.13
The second sentence of the section reads:
has been changed to correct the factual
“The total costs for a monopolar TURP were
inaccuracy.
£1196.60 for hospitals using Olympus systems and
£1125.60 for other hospitals.”
Table 54 of the Additional economic analysis by EAC
document has this value as £1125.69.
Table 54: Cost per case based on all inputs made
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MT217 The TURis system for transurethral resection of the prostate
Com.
no.
Consultee number
and organisation
Sec. no.
Comments
Response
by the EAC to the sponsor’s model
The revised text should read:
“The total costs for a monopolar TURP were £1196.60 for
hospitals using Olympus systems and £1125.69 for other
hospitals.”
4
1. Olympus
Cost evidence
5.15
Thank you for your comment. Section 5.15
The section reads:
has been changed to correct the factual
“The External Assessment Centre calculated a
revised result based on the meta-analysis results for inaccuracies.
the length of hospital stay at the request of the
Committee. The results for the recalculated base
case in the External Assessment Centre’s revised
model found a total cost per TURis procedure in
Olympus centres of £1183.99 and in non-Olympus
centres of £1203.44. The total costs for a monopolar
TURP were £1196.60 for a hospital using Olympus
systems and £1145.49 for other hospitals. TURis was
cost saving for a hospital using Olympus systems by
£19.80, but added costs of £70.75 for other
hospitals.”
This section should relate to section 2.1 of the
Additional economic analysis by EAC document,
which reads:
“Following discussion of methods applied by the EAC
in writing the Assessment Report and notable
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MT217 The TURis system for transurethral resection of the prostate
Com.
no.
Consultee number
and organisation
Sec. no.
Comments
Response
heterogeneity of the source data, the committee
requested that the model be run assuming that TURis
reduces hospital stay by an average of 0.19 days.
TURis then becomes increasingly cost saving to
£70.55 per case for existing Olympus customers and
remains cost incurring by £19.80 per case for nonOlympus customers.
Model results based on EAC model inputs and
with a difference in hospital stay of 0.19 days in
favour of TURis: cost per case
.”
The figures are misquoted, and the revised text
should read:
“The External Assessment Centre calculated a revised
result based on the meta-analysis results for the length of
hospital stay at the request of the Committee. The
results for the recalculated base case in the External
Assessment Centre’s revised model found a total cost per
TURis procedure in Olympus centres of £1,126.04 and in
non-Olympus centres of £1,145.49. The total costs for a
monopolar TURP were £1196.60 for a hospital using
Olympus systems and £1,125.69 for other hospitals.
TURis was cost saving for a hospital using Olympus
systems by £70.55, but added costs of £19.80 for other
hospitals.”
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MT217 The TURis system for transurethral resection of the prostate
Com.
no.
Consultee number
and organisation
5
6
Sec. no.
Comments
Response
2. The Royal College general
of Pathologists
The Royal College of Pathologists does not wish to
be involved in this project.
Thank you for your comment.
3. Prostate Cancer
UK
Dear Sir/Madam,
Re: The TURis system for transurethral resection of the
prostate: appraisal consultation
Thank you for providing the opportunity for Prostate
Cancer UK to respond to NICE’s consultation on guidance
for using the transurethral resection in saline (TURis)
system for transurethral resection of the prostate (TURP)
to treat benign prostatic enlargement (BPE) in the NHS in
England.
About us
Prostate Cancer UK is the UK’s leading charity for men
with prostate cancer and prostate problems. We support
men and provide information, find answers through
funding research and lead change to raise awareness and
improve care. The charity is committed to ensuring the
voice of people affected by prostate disease is at the heart
of all we do.
Consultation response
1.
Has all of the relevant evidence been taken into
account?
We believe that the evidence submitted by the sponsor is
fully comprehensive and has been adequately considered
by the External Assessment Centre. We were particularly
glad to see a consideration of quality of life benefits.
However, we recommend making the specific quality of
life benefits outlined in our previous comments on TURis
to NICE more explicit in the final guidance, namely:
•
Reduced catheter use (1)
•
Reduced post operative dysuria (painful urination)
Thank you for your comment. Quality of
life and time of removal of catheter were
included as outcomes in the evaluation
scope.
The evidence presented on the impact of
TURis on catheter use is summarised in
section 3.21 and the Committee’s
considerations are described in section
3.27 of the guidance. The time to catheter
removal did not differ significantly between
TURis and TURP.
No evidence was presented on the
incidence of dysuria. The MTEP team
sought expert advice on this issue which is
attached as Appendix 1. In summary,
experts state that dysuria symptoms are
short lived, are not clinically significant in
transurethral procedures and that the rate
is similar for TURis and TURP.
The Committee discussed the additional
expert advice and concluded that the
existing statements on quality of life issues
accurately reflected the evidence
presented for TURis and decided not to
change the guidance.
general
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MT217 The TURis system for transurethral resection of the prostate
Com.
no.
Consultee number
and organisation
7
3. Prostate Cancer
UK
8
3. Prostate Cancer
UK
9
3. Prostate Cancer
UK
Sec. no.
Comments
Response
(2)
2.
Are the summaries of clinical effectiveness and
resource savings reasonable interpretations of the
evidence?
Yes.
3.
Are the provisional recommendations sound, and a
suitable basis for guidance to the NHS?
As stated above, we recommend detailing the quality of
life benefits gained from using the TURis system in
recommendation 1.1.
We welcome the clarity of recommendation 1.2, which
makes the cost benefits clear for hospitals that already
use an Olympus monopolar system, as well as for those
hospitals that would need to purchase one. As the
implementation of NICE medical technologies guidance is
subject to local commissioning decisions, this will assist
local commissioners in justifying the use of the TURis
system.
Building on this, we also recommend including the
additional information of cost per patient, as well as
highlighting training requirements, in recommendation 1.2.
Including this information will provide local commissioners
with additional data that will assist with their prioritisation
processes.
4.
Are there any equality issues that need special
consideration and are not covered in the medical
technology consultation document?
Age based inequalities
As BPE predominantly affects older men, we recommend
for men to be assessed for surgical intervention on the
basis of what is clinically appropriate for them, including
their fitness, and not on the basis of their age alone.
Macmillan Cancer Support’s report, The Age Old Excuse:
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Thank you for your comment.
Thank you for your comment.
Please refer to the response to comment 6
in relation to quality of life.
Section 1.2 contains the estimated cost
impact per patient.
Sections 4.2 and 4.3 describe the training
requirements and the Committee’s
considerations on training, which it judged
to be minimal, based on consistent advice
from several expert advisers.
The Committee decided to change section
4.6 to make further reference to the training
requirements for TURis.
Thank you for your comment.
The Equality Impact Assessment published
during consultation identifies that the
incidence of lower urinary tract symptoms
in men increase with age. The
recommendations do not hinder access to
the technology for any specific group.
MT217 The TURis system for transurethral resection of the prostate
Com.
no.
Consultee number
and organisation
Sec. no.
Comments
Response
The Under Treatment of Older Cancer Patients, highlights
that the number of patients undergoing surgical treatment
reduces with age (3). Macmillan argues that treatment
decisions can often be biased towards an assumption that
an older person may not be able to withstand intensive
treatment, due to frailty or comorbidity.
To counter this, the report calls for more adequate
individual health assessments, as assumptions are too
often resulting in clinical decisions about treatment being
based solely on age, rather than the fitness level of the
individual patient.
Further evidence that age impacts on access to surgery
was included in Cancer Research UK’s survey of
surgeons, in which age was cited as the second highest
reason for denying a patient surgery (35%) (4).
Equality of access
NICE guidance for the TURis system is being developed
as medical technologies guidance. However, “with the
exception of technology appraisals, which carry a funding
directive for commissioners, NICE guidance is not
mandatory” (5). Therefore, under NICE medical
technologies guidance for this system, access would be
subject to local commissioning decisions, which could
lead to variations in access.
Thank you again for this opportunity to respond to NICE’s
consultation on guidance for using the TURis system for
TURP to treat BPE in the NHS in England.
Yours faithfully,
XXXXXXXXXXXX
XXXXXXXXXXXXXXX, Prostate Cancer UK
References
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MT217 The TURis system for transurethral resection of the prostate
Com.
no.
Consultee number
and organisation
Sec. no.
Comments
Response
1.
Prinjha S, Chapple A. Living with an indwelling
urinary catheter [Internet]. 2013. Available from:
http://www.nursingtimes.net/Journals/2013/11/01/q/g/i/061
113-Living-with-an-indwelling-urinary-catheter.pdf
2.
Singh H, Desai MR, Shrivastav P, Vani K. Bipolar
versus monopolar transurethral resection of prostate:
randomized controlled study. J Endourol Endourol Soc.
2005 Apr;19(3):333–8.
3.
Macmillan Cancer Support. The Age Old Excuse:
The Under Treatment of Older Cancer Patients [Internet].
2014. Available from:
http://www.macmillan.org.uk/Documents/GetInvolved/Cam
paigns/AgeOldExcuse/AgeOldExcuseReportMacmillanCancerSupport.pdf
4.
Cancer Research UK. An evaluation of cancer
surgery services in the UK [Internet]. 2014. Available from:
https://www.cancerresearchuk.org/sites/default/files/policy
_cruk_cancer_surgery_services_feb14.pdf
5.
NICE guidance | Our programmes | What we do |
About | NICE [Internet]. [cited 2014 Oct 21]. Available
from: http://www.nice.org.uk/about/what-we-do/ourprogrammes/nice-guidance
10
y4 External
yAssessment Centre
Page 17 section
3.25
(Re hospital stay) This section contains: “The
External Assessment Centre confirmed that it
excluded the Chen et al. (2009) study because it was
the source of significant heterogeneity in the metaanalysis results. However, the External Assessment
Centre stated that it did not differ in terms of baseline
characteristics of patients or in methodological quality
from the 2 included studies.”
The statement is true (i.e. I did say that) but having
had another look at the Chen 2009 study some
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Thank you for your comment.
The Committee decided to change section
3.25 to more accurately describe the
baseline characteristics of patients in the
Chen 2009 study.
MT217 The TURis system for transurethral resection of the prostate
Com.
no.
Consultee number
and organisation
Sec. no.
Comments
Response
differences may be worth noting. Across all of the
randomised trials (of which three enabled metaanalysis of hospital stay), most are fairly similar in
terms of baseline prostate size, which ranges
typically from 45g – 60g. The Chen 2009 study
actually has the largest baseline prostate size of 78g.
As the MTAC Chair pointed out at the meeting on
11th September, this study also has the longest
procedure times for both TURis (88 minutes) and
monopolar TURP (105 minutes), whereas the other
studies seldom exceed 60 minutes for procedure time
(only one other does: Fagerstrom with 62 minutes &
66 minutes). These two factors may support the
argument that the Chen 2009 study may differ from
typical studies, though the EAC’s main concern was
that decisions to discharge patients from hospital
may differ internationally.
Should the statement in the consultation guidance “the
External Assessment Centre stated that it did not differ in
terms of baseline characteristics of patients.........” be
reconsidered?
11
4 External
Assessment Centre
Page 23 section
5.11
Paragraph reads: “The External Assessment Centre
disagreed with the sponsor’s costs for blood
transfusion, which it felt over-estimated the true costs
because several components were included that
would not typically be required. The External
Assessment Centre estimated the cost of a blood
transfusion to be £329, based on the cost of 2.7 units
of red blood cells.”
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Thank you for your comment.
The Committee decided to change the
wording of section 5.11, in line with the
consultee’s suggestion, to further clarify the
description of the evidence assessment.
MT217 The TURis system for transurethral resection of the prostate
Com.
no.
Consultee number
and organisation
Sec. no.
Comments
Response
This is entirely correct though I’d suggest avoidance
of the word ‘disagreed’. I suggest the following as I
think it sounds less adversarial:
“The External Assessment Centre felt that the
sponsor’s costs for blood transfusion over-estimated
the true costs because several components were
included that would not typically be required. The
External Assessment Centre estimated the cost of a
blood transfusion to be £329, based on the cost of
2.7 units of red blood cells.”
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Page 25 section
5.17
The last sentence reads:
“The Committee considered that the meta-analysis
results for the length of hospital stay should be
included in the cost model and asked the External
Assessment Centre to recalculate the model results.”
I suggest an amendment as follows:
“The Committee considered that a difference in the
length of hospital stay of 0.19 days in favour of TURis
should be included in the cost model based on the
External Assessment Centre meta-analysis and
requested that the External Assessment to
recalculate the model results on this basis”.
Rationale
Because this was a change from zero difference to
9 of 12
Thank you for your comment.
The Committee decided to change the
wording of section 5.17 in line with the
consultee’s suggestion.
MT217 The TURis system for transurethral resection of the prostate
Com.
no.
Consultee number
and organisation
Sec. no.
Comments
Response
0.19 days: the suggested wording is more
informative.
"Comments received in the course of consultations carried out by NICE are published in the interests of openness and transparency, and to promote
understanding of how recommendations are developed. The comments are published as a record of the submissions that NICE has received, and are
not endorsed by NICE, its officers or Advisory committees."
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MT217 The TURis system for transurethral resection of the prostate
Appendix 1: Additional expert advice.
Question: We have been asked about the effect of TURis on post-operative dysuria. As this symptom isn’t specifically mentioned in
the clinical trials, we wondered whether urethral stricture might be a proxy for this? (on the assumption an urethral stricture would
be painful during urination and it is a documented post-operative symptom) Any other comments you have on dysuria in relation to
TURis or TURP would also be very useful.
Expert Adviser
Dr Andrew Dickinson
Mr Neil Barber
Comment
from clinical experience dysuria post TURis does not seem to be any larger a problem than dysuria post
TURP, and both have significantly less dysuria than post Green light Laser patients. In my judgement post
op dysuria is not a significant clinic problem. With regard to urethral strictures I don’t think this would be a
proxy for dysuria. However as it is a known complication of bladder outflow obstructive surgery it should be
looked at as a separate problem. The problem being is that this data will only develop with time as urethral
strictures are a late complication developing from 6-12 months onwards post-surgery
Some studies do ask about dysuria but it is not often included in the final reports and of course is never one
of the important end points. I would not suggest that it can be considered a marker of risk or be considered
related to the formation of a urethral stricture.
I am not aware of any clinical feeling that there is any difference in the incidence of severe dysuria
betweeen monopolar and bipolar TURP - the usual place of comparison is TURP vs laser prostatectomy.
Indeed there probably is data on this hidden away in the results of GOLIATH, a multicentred pan eurpoean
randomised trial of TUTRP vs Greenlight XPS laser prostatectomy - dysuria etc was specifically measured in the TURP arm there was almost an equal split of monopolar vs bipolar TURP. Unfortunately, this data is
held by American Medical Systems who are unlikely to be motivated to ever release/ publish it
Mr Mark Speakman
The long and short of it - is that I would consider any questions of differences as regars dysuria an
unimportant and clinically irrelevant side issue
Specifically dysuria is pain on voiding whilst a stricture narrows the water pipe and results in a reduced
speed of urine flow.
Dysuria is very similar between traditional mon-polar TURP and the newer bipolar TURPs such as TURis.
The dysuria comes from the raw surface that is left after the resection and is similar in both.
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MT217 The TURis system for transurethral resection of the prostate
Mr Ian Pearce
Stricture is completely different and it has been suggested (anecdotally) that stricture was more common –
particularly with the older mono-polar TURPs because more of the heat was dissipated via the sheath of the
scope. I am sure you have looked closely at strictures between std TURP and TURis and this is important
In fact urethral stricture disease does not classically cause dysuria, but rather spraying and splitting of the
urinary stream. It is, as you say, a recognised complication of TURP - both monopolar and bipolar and
occurs as a consequence of urethral trauma and scar formation and is probably caused by the
resectoscope sheath rather than the mode of diathermy employed, hence is likely to be similar for both
forms.
Dysuria post TURP is part of this process in the early stage - in other words, dysuria secondary to urethral
trauma caused by the scope itself and as such the rates are likely to be identical.
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