Download Single-incision sub-urethral short tape insertion for stress

Issue date May 2008
Understanding NICE guidance
Information for people who use NHS
services
Surgery to treat stress urinary
incontinence using short synthetic
tape by single incision in women
NICE ‘interventional
procedures
guidance’ advises
the NHS on when
and how new
procedures can be
used in clinical
practice.
This leaflet is about when and how a special type of synthetic tape can
be used in the NHS to treat women with stress urinary incontinence. It
explains guidance (advice) from NICE (the National Institute for Health
and Clinical Excellence).
Interventional procedures guidance makes recommendations on the
safety of a procedure and how well it works. An interventional
procedure is a test, treatment or surgery that involves a cut or puncture
of the skin, or an endoscope to look inside the body, or energy sources
such as X-rays, heat or ultrasound. The guidance does not cover
whether or not the NHS should fund a procedure. Decisions about
funding are taken by local NHS bodies (primary care trusts and hospital
trusts) after considering how well the procedure works and whether it
represents value for money for the NHS.
NICE has produced this guidance because the procedure is quite new.
This means that there is not a lot of information yet about how well it
works, how safe it is and which patients will benefit most from it.
This leaflet is written to help people who have been offered this
procedure to decide whether to agree (consent) to it or not. It does not
describe stress urinary incontinence or the procedure in detail – a
member of your healthcare team should also give you full information
and advice about these. The leaflet includes some questions you may
want to ask your doctor to help you reach a decision. Some sources of
further information and support are on page 6.
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What has NICE said?
Currently, there is not a lot of evidence about how well this
procedure works or how safe it is. For these reasons, NICE has
said that this procedure should only be carried out either as part of
a research study or if details of patients and what happens to them
after the operation are included in a national register of information.
The procedure should only be done by a doctor who has had
special training in this operation. It is also important that patients
are followed up to see if the procedure has worked in the long
term.
NICE may look at the procedure again if more information
becomes available.
This procedure may
not be the only
possible treatment
for stress urinary
incontinence.
Your healthcare
team should talk to
you about whether
it is suitable for you
and about any other
treatment options
available.
Surgical insertion of short synthetic tape under the
urethra
The procedure is not described in detail here – please talk to your
specialist for a full description.
Stress urinary incontinence is the accidental leakage of small amounts
of urine when exercising, coughing, sneezing or laughing. It is more
common in women who have given birth, but it may occur in all women.
Pelvic floor exercises can help to strengthen the muscles that hold the
bladder and urethra (the passage through which urine leaves the
bladder) in place. Other lifestyle changes may also help – for example,
losing weight. However, if the condition does not improve, an operation
may be needed.
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The procedure described here is called single-incision sub-urethral
short tape insertion. It involves making a small cut in the vaginal wall.
The surgeon then inserts a short strip of synthetic mesh tape under the
urethra with the help of a special introducer. The tape provides extra
support for the urethra, which helps to stop urine leaking. The tape may
be placed in a hammock or ‘U’ position. A special telescope
(cystoscope) is then placed via the urethra to check that the bladder
has not been damaged. The procedure can be carried out under local
or general anaesthetic.
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What does this mean for me?
NICE has said that there is not enough evidence about how safe this
procedure is or about how well it works. Your doctor should only offer
you this procedure as part of a clinical trial or if your details and what
has happened to you after the operation are included in a national
store of information.
You may want to ask the questions below

What does the procedure involve?

What are the benefits I might get?

How good are my chances of getting those benefits? Could
having the procedure make me feel worse?

Are there alternative procedures?

What are the risks of the procedure?

Are the risks minor or serious? How likely are they to happen?

What care will I need after the operation?

What happens if something goes wrong?

What may happen if I don’t have the procedure?
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You might decide to
have this procedure,
to have a different
procedure, or not to
have a procedure
at all.
Summary of possible benefits and risks
Some of the benefits and risks seen in the studies considered by NICE
are briefly described below. NICE looked at six studies on this
procedure.
How well does the procedure work?
One study of 15 women reported that most of them (93%) had no
problems with stress urinary incontinence when they were followed up
at 1–3 months after surgery.
As well as looking at this study, NICE also asked expert advisers for
their views. These advisers are clinical specialists in this field of
medicine. The advisers said that the impact of the procedure on a
patient’s quality of life is important. Some advisers said that there is a
lack of information about how well the procedure works in the long term
and how it compares with other treatments.
Risks and possible problems
Damage to the bladder occurred in two women from two studies which
looked at a total of 102 women undergoing the procedure. Two further
studies of 64 women reported no damage to the bowel or urethra after
the procedure.
Unintentional damage to the vaginal wall occurred in two women in one
study of 40 women undergoing the procedure.
Three separate studies (a total of 127 women) reported that one woman
in each study had damage to the vaginal wall caused by the tape
eroding (exposure) through it. In another study, the vaginal incision had
split open after the procedure in 4 of the 24 women that were looked at.
Three studies involving 152 women reported new bladder problems
after the procedure in 3% to 16% of women. Some of these women
experienced urgency.
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As well as looking at these studies, NICE also asked expert advisers for
their views. These advisers are clinical specialists in this field of
medicine. The advisers said that pain, bleeding, damage to the bladder,
erosion of the tape, tearing of the tissue at the surgical cut, problems in
emptying the bladder and pain during sex were potential problems with
this procedure.
More information about stress urinary incontinence
NHS Direct online (www.nhsdirect.nhs.uk) may be a good starting point
for finding out more. Your local Patient Advice and Liaison Service
(PALS) may also be able to give you further advice and support.
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About NICE
NICE produces guidance (advice) for the NHS about preventing,
diagnosing and treating different medical conditions. The guidance is
written by independent experts including healthcare professionals
and people representing patients and carers. They consider how
well an interventional procedure works and how safe it is, and ask
the opinions of expert advisers. Interventional procedures guidance
applies to the whole of the NHS in England, Wales, Scotland and
Northern Ireland. Staff working in the NHS are expected to follow
this guidance.
To find out more about NICE, its work and how it reaches decisions,
see www.nice.org.uk/aboutguidance
This leaflet is about ‘Single-incision sub-urethral short tape insertion
for stress urinary incontinence in women’. This leaflet and the full
guidance aimed at healthcare professionals are also available at
www.nice.org.uk/IPG262
You can order printed copies of this leaflet from NICE publications
(phone 0845 003 7783 or email [email protected] and quote
reference N1581).
We encourage voluntary sector organisations, NHS organisations
and clinicians to use text from this booklet in their own information
about this procedure.
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National Institute for Health and Clinical Excellence
MidCity Place, 71 High Holborn, London, WC1V 6NA; www.nice.org.uk
ISBN 1-84629-711-7
N1581 1P May 08
© National Institute for Health and Clinical Excellence, 2008. All rights
reserved. This material may be freely reproduced for educational and not-forprofit purposes. No reproduction by or for commercial organisations, or for
commercial purposes, is allowed without the express written permission of the
Institute.
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