TRUST LOGO
A Randomised trial of treating Fibroids with either
Embolisation or Myomectomy to Measure the
Effect on quality of life, among women wishing to
avoid hysterectomy: the FEMME study
Contact details.
FEMME Study Local Organisers
Doctor:
Nurse:
Telephone:
FEMME Study Central Organisers
William McKinnon
FEMME Study Office,
Birmingham Clinical Trials Unit,
Robert Aitken Institute,
Birmingham
B15 2TT
Tel: 0121 414 8335.
email: w.mckinnon@bham.ac.uk
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FEMME Participant Information Sheet (Blood Centres)
Version 1.5 04th November 2013
Invitation to take part in the FEMME Study
You have fibroids which your doctor believes can be treated equally well by either a
technique called uterine artery embolisation (UAE) or conventional surgery (myomectomy).
We would be grateful if you would consider taking part in our study comparing which of
these procedures is best for improving the quality of life in women with fibroids.
Taking part in this study is entirely up to you, and you don’t have to take part if you don’t
want to. Before you decide we’d just like to explain a little more about our study, why it is
being done and what taking part will involve.
Please take your time to read this information sheet carefully, and feel free to talk with
your friends and family about taking part. If there is anything that is not clear, or if you
would like more information, you should ask your gynaecologist, interventional radiologist
or the research nurse who will be delighted to answer any questions you may have.
Part 1 tells you the purpose of this study and what will happen to you if you take part
Part 2 gives you more detailed information about the conduct of the study
Part 1:
Some background information on your fibroids
Fibroids are a very common, non-cancerous growth that can occur in a number of places
in the womb (uterus). Being very common, most women will develop at least one fibroid at
some point in their life but many will be unaware that they have one. Depending on the
number, size and position of the fibroids in some women they can cause symptoms like
pain during sex, heavy bleeding, abdominal pain, bloating, feeling constantly tired and a
feeling of always needing to go to the toilet. Any of these symptoms can cause a
significant decrease in the quality of life experienced by women with fibroids.
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What are the standard treatments for fibroids?
One of the standard surgical treatments for fibroids is called hysterectomy. Hysterectomy
is quite a major operation where the entire womb is surgically removed. With many women
associating their womb with their femininity and sexuality, and with fibroids being a benign
condition, many women are asking if they are losing their wombs unnecessarily when they
have a hysterectomy. As it removes the womb, hysterectomy is not an option for women
who may want to try to have children.
More recently other techniques have been developed which treat the fibroid and allow the
woman to keep her womb.
The first of these treatments is called myomectomy. This is a procedure whereby the
fibroid is removed by a variety of surgical techniques. The second treatment is called
Uterine Artery Embolisation and is often called UAE.
The National Centre for Health and Clinical Excellence (NICE) has issued guidelines
outlining treatments for heavy menstrual bleeding (reference CG44). You can download
these from NICE’s website www.nice.org.uk, or you can request them by email
publications@nice.org.uk or ‘phone 0845 003 7783.
What do the procedures involve?
A myomectomy is a surgical procedure performed under general anaesthetic. There are
three ways the surgeon can reach the fibroid:

Through small holes made in the abdominal wall (Laparoscopic or keyhole surgery)

Through the vagina and neck of the womb (Hysteroscopic)

Through a horizontal or vertical cut in the abdomen (Open surgery)
The surgeon will decide on which route to use depending on the size, number and location
of your fibroids. Your surgeon will discuss this decision with you.
UAE is routinely performed under local anaesthetic and is usually completed within one
hour. In UAE a small tube is introduced into the blood supply to the fibroid. Once in place
small beads are placed into the blood vessel which reduces the blood flow to fibroids. This
causes the fibroids to shrink over a period of several months and so relieves the
symptoms.
When will I be able to go home and when will I be OK to return to normal
activities?
The recovery times are different for the two procedures. After UAE, most women can
leave hospital in less than 48 hours but should rest at home for 1-2 days. The length of
stay in hospital after a myomectomy depends on the procedure used and is around 2-3
days after a keyhole or hysteroscopic procedure, and 3-7 days after open surgery.
These figures are guides and just how quickly you return to normal activities will depend
on many factors. Your doctor will be able to give you more specific advice regarding
returning to work or normal activities after your procedure.
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What is the purpose of the study?
UAE and myomectomy are both safe, effective procedures that are readily available on the
NHS, but doctors do not know which is best in improving the quality of life for women with
fibroids. It is important to compare the two procedures against each other and our study
will do this.
Why have I been asked to take part?
You have been asked if you would like to take part in this study as you have fibroids that
your doctor believes can be treated equally well by either UAE or myomectomy. Please be
assured that as it is important that you always receive the best treatment for you that if
your doctor felt that one treatment would be more beneficial to you they would not have
invited you to take part in this study.
Do I have to take part?
It is entirely up to you if you want to take part in this study. You do not have to take part if
you don’t want to and you do not have to give a reason why. If you do not want to take part
in this study then the standard of care you will receive will not be affected.
If you do decide to take part in this study but later change your mind then you are free to
withdraw from the study at any time. As before, you don’t have to give a reason why you
have changed your mind and don’t want to take part, and this will not change the standard
of your medical care in any way.
Participation in this study will not affect any private health insurance.
What will happen to me if I take part?
If the doctor feels that your fibroids can be treated by UAE or myomectomy, and if you
agree to take part in the trial, you will be asked to sign a consent form to say that the trial
has been explained to you, that you understand what taking part in the trial will involve and
that you are willing to take part.
You will be asked to complete a questionnaire which will record how your fibroid is
affecting your quality of life and then hand this back to the nurse.
With your permission, we would like to take 10 mls (two teaspoons) of blood. This will be
used to measure the levels of the hormones associated with your fertility (ovarian reserve).
All your blood samples will be stored securely under a trial number at the University of
Birmingham until the end of the study when they will be sent to the University of Glasgow
where the hormone levels will be measured. You will not be able to see your specific
results but we will give you the pooled results of all the other women who had the same
operation as you did. After the study is finished we’d like to keep your blood sample for
use in future studies.
You will then be assigned to have either a UAE or a myomectomy. You have an equal
chance of having a myomectomy or a UAE but which operation you have will be chosen at
random and neither you nor your doctor can choose what it will be. As your doctor will
always act in your best interest this is why they must feel that your fibroids will respond
equally well to both myomectomy or UAE. As the treatment is always chosen at random
this also means that if you have a preference for the treatment you’d like to receive then
you won’t be able to take part in the trial. At the end of the day it is your body and you
must be happy with the treatment you receive.
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If you have not already had one, you may have a magnetic resonance imaging scan (MRI)
to get a more detailed picture of the fibroid(s) in your uterus. The scan is completely
painless and there are no known risks or side-effects. You will be asked to lie still in the
scanner for 10-15 minutes. The scanner can be very noisy and hearing protection will be
given. You will be able to contact the radiographer at all times during the scan if you need
assistance. A small injection of special dye will be given into one of the veins in your arm.
If I take part in the FEMME study, what else will happen after the
procedure?
You will have a routine check-up at 6 weeks after your myomectomy or UAE procedure. At
6 months, you may be invited to return for a follow-up MRI scan to see how successful the
treatment has been and you will be asked to fill in the same questionnaires you completed
before the procedure.
The same questionnaires will be sent to you at home at 1, 2 and 4 years after your
operation. This will allow us to measure how your quality of life changes over time and see
which treatment is best to offer to women with fibroids. To be as certain as possible that
our answer is correct it is important to find out how all women who are taking part are
progressing so the study organisers may telephone, text or email you to remind you to
complete the questionnaires.
We would like to repeat your blood test at 6 weeks, 6 months and 12 months after your
operation to see if your procedure has affected the levels of hormones associated with
ovarian function.
Should you get pregnant at any time after the procedure, we would like you to contact the
Trial Office. We would like to collect a few details about the outcome of the pregnancy,
which we will do by telephone or through your GP.
What are the risks and discomforts?
Myomectomy and UAE are both safe procedures and are in routine use within the NHS.
Some studies have suggested that women who have a UAE recover from their operation
more quickly than those who have a myomectomy, but may be more likely to have the
need for more treatment in the future. On top of this, both myomectomy and UAE are
associated with a range of complications. Although rare the risks of each procedure can
include:
Myomectomy
•
•
•
•
•
•
•
Haemorrhage
Injury to the uterus
Damage to the nearby organs of the urinary system
Formation of scar tissue (adhesions) within the uterus
Infection
Blood clots
Eventual re-growth of fibroids.
The effect that myomectomy has on the chance of getting pregnant is unknown at present.
UAE
•
Damage to the uterus, bladder, vulva and ovaries
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•
•
•
•
Flu-like symptoms
Pain
Vaginal discharge
Early menopause.
The effect that UAE has on the chance of getting pregnant is unknown at present.
In order to ensure that the tube delivering the beads is in the right place it will be guided
there under x-ray imaging. Whilst any exposure to ionising radiation carries an increased
risk of developing cancer, it is the size of this risk that is important. The lifetime risk of
developing a fatal cancer following UAE is 1 in 3,330. This is similar to the lifetime risk of
dying from an accident at work in the manufacturing industry, and a lot less than the
lifetime risk of dying in a transportation accident in the UK (1 in 240).
Your doctor will discuss the risks and discomforts of the allocated treatment and give you
more details of what to do if you experience any side effects.
Are there any benefits for me from taking part in the study?
You will not gain any individual benefit by taking part in the study but the trial will provide
valuable information to decide which treatment is best for future women suffering from
fibroids.
What if there is a problem?
Any complaint about the way you have been dealt with during the study or any possible
harm you might suffer will be taken very seriously, thoroughly investigated and any matters
arising will be addressed. Detailed information on who to contact to raise a concern is
given in Part 2 (What if there is a problem?).
If the information in Part 1 has interested you and you are considering taking part,
please read the additional information in Part 2 before making any decisions
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Part 2: Conduct of the study
What will happen if I don’t want to carry on with the study?
If you change your mind and decide that you do not want to continue taking part in the
study you can withdraw at any time. You don’t have to give a reason why you no longer
wish to take part, and withdrawing will not affect the standard of your medical care in any
way.
If you do decide that you no longer wish to take part then we would like to use the
information collected about you up to the point of your withdrawal. In the unlikely event of
you losing the ability to give continued consent during the study we would like to keep data
that we have already collected about you and include it in our study.
Will information about me be kept confidential?
Yes. Like your medical records all information collected in the study will be held securely
and remain strictly confidential. If you agree to take part, your doctor will send basic
information about you and your condition to the study’s central organisers at the University
of Birmingham’s Clinical Trials Unit. This information will be put into a computer and
assigned a code number. The answers you give be will be identified using this code
number, not your name. Any information you give will not be seen by your GP or
gynaecologist.
No information from which you can be identified will be published in the study report.
Information held by the NHS may be used to keep in touch with women taking part in the
study and follow up their health status. Occasionally, inspections of clinical study data are
undertaken to ensure that, for example, all participants have given consent to take part, so
a copy of your consent form will be sent to the FEMME study office. Selected members of
bodies responsible for good conduct of the trial from the University of Oxford or the NHS
Trusts may also be given access to data to ensure we are complying with regulations. But,
apart from this, only a very small number of study organisers will have access to your
personal data.
Involvement of the General Practitioner/Family doctor (GP)
With your consent we will inform your GP of your participation in the FEMME Study. Your
GP will not be able to access your answers or any of the information we hold on you.
Even if you no longer wish to complete the questionnaires, we would like to continue to
collect a few important details from your GP, such as information on repeat surgeries, if
you get pregnant and the outcome of this pregnancy.
What will happen to the results of the research study?
The results will be reported in a medical journal. It is expected that the first results will be
published about two years after the study finishes recruiting women. Everyone who takes
part will then be told the results in a newsletter that will be posted directly to them.
Who is funding and organising the research?
The FEMME study researchers are receiving a grant from the National Institute for Health
Research’s Health Technology Assessment programme (NIHR HTA) to enable them to
carry out this study.
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The study is being sponsored by the University of Oxford, co-ordinated from Birmingham
Clinical Trials Unit and being run with significant input from clinical staff based in Glasgow
(Royal Infirmary) and London (St. George’s Hospital).
No one involved is being paid for recruiting women into the study. Patients are not paid to
take part either, but their help in finding out more about how best to treat fibroids is very
much appreciated.
Who has reviewed the study?
All research in the NHS is overseen by an independent group of people called a Research
Ethics Committee (REC) whose role is to ensure your safety, rights, wellbeing and dignity
at all times. This study has been reviewed and given a favourable opinion by the Coventry
and Warwickshire REC.
This study has also been reviewed by the Research and Development (R&D) Department
for each hospital trust taking part in the trial.
What if there is a problem?
The study is being sponsored by the University of Oxford who have arrangements in place
to provide compensation in the extremely unlikely event that you suffer lasting harm from
participation in the study. NHS indemnity operates in respect of the clinical treatment you
receive.
You have the same legal rights whether or not you take part in this study.
If you wish to complain about any aspect of the way in which you have been approached
or treated during the course of this study you should initially contact the local investigator
named on the cover of this information sheet. If you are unhappy with their response then
you should raise your concern with the University of Oxford’s Clinical Trials and Research
Governance
(CTRG)
office
on
01865
857939
or
by
email
(heather.house@admin.ox.ac.uk).
Do you have any further questions?
Having read this leaflet, we hope that you will choose to take part in the FEMME Study. If
you have any questions about the study now or later feel free to ask your gynaecologist or
clinic nurse. Their names and telephone numbers are given on the front of this leaflet.
Please take the time to decide whether you wish to take part in the FEMME Study. Please
feel free to discuss your decision with friends or relatives.
If you require any general information about research the UK Clinical Research
Collaboration has produced a useful guide entitled, ‘Understanding Clinical Trials’. This
can be downloaded from their website: www.ukcrn.org.uk. If you require specific
information about the research project please either contact any of the FEMME staff listed
on the front page or visit our website: www.birmingham.ac.uk/femme. Only the clinical staff
can give you advice about your medical conditions and the surgical options that may be
available to you.
Thank you for taking the time to read this Participant Information Sheet
about the FEMME Study.
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Version 1.5 04th November 2013