I've been diagnosed with fibroids - what do I do?
With fibroids being very common in women it is important that you realise you are not alone.
You can get impartial advice on your fibroids from NHS Direct.
In addition to this a number of very good support groups have been set up by women who have had fibroids. These groups are all independent of FEMME and their sites provide advice to women with fibroids and let them know of the treatment options that should be available to them.
These groups include:
The British Fibroid Trust
The Fibroid Network Online
What is FEMME?
As you may be aware there a number of treatments available for fibroids.
In the NHS the treatments offered to treat fibroids are commonly Uterine Artery Embolisation (using small beads to reduce the blood flow to the fibroid) or myomectomy (surgically removing the fibroid). Depending on the size and position of your fibroids your gynaecologist will recommend which procedure they feel is best for you.
It may be that your gynaecologist feels that both myomectomy and Uterine Artery Embolisation will be equally effective in treating your fibroids (known as equipoise). If this is the case then we'd be grateful if you would consider taking part in FEMME
FEMME is funded by part of the NHS known as the National Institute for Health Research Health Technology Assessment programme. The aim of FEMME is to measure the changes in the quality of life women experience after their fibroids are treated with myomectomy or Uterine Artery Embolisation.
How do I find out more about FEMME?
We have some documents that give some more detailed information about FEMME and why were doing the trial. A brief introduction of the FEMME trial is given in our pamphlet.
All the information on FEMME is summarised in the Participant Information Sheet. More detailed information on FEMME is available from the Study Protocol.
If you are interested in taking part in FEMME then please take your time to read these documents carefully and discuss them with your family, friends and healthcare providers.
If I join FEMME can I choose my treatment?
To be considered for the FEMME trial your gynaecologist must feel that your fibroids will be treated equally well with myomectomy or Uterine Artery Embolisation.If you join the FEMME trial then the treatment you receive will be decided at random. This is done to stop something called sampling bias and to ensure that the results we get from the trial are true.
This means that if you have a preference for which treatment you'd like to receive for your fibroids then you won't be able to take part in FEMME.
What do I have to do in FEMME?
In order to see how myomectomy and Uterine Artery Embolisation affects the function of your ovaries we would like to take a 10 ml sample (around a two teaspoons of blood) before you have your operation and then again at 6 weeks, 6 months and 12 months after your operation.
To measure how you feel six months after your operation we will give you a Quality of Life questionnaire to fill in. We will ask you to fill in this questionnaire again at one year, two years and four years after your operation. Your answers will be compared with those you give before you had your operation. You can have a look at the questionnaires we'd like you to fill in on the Trial Documentation page.
Do I get paid for taking part in FEMME?
As FEMME is funded by the research arm of the NHS there is no money to pay people for taking part in FEMME. We do have some funds available to refund your traveling costs for any additional visits to the hospital. To claim these travelling costs please complete this form and return it with your receipts to William McKinnon in Birmingham Clinical Trials Unit.
Are there any risks involved in me taking part in FEMME?
As with all surgical procedures there is always a slight risk. As FEMME is comparing two standard surgical techniques, both of which are routinely used in the NHS, you are at no more risk in taking part in FEMME than you would be when you receive your normal surgical care.
Who sees my information? I don't want people to know all my details
The only people who will know your name and contact details will be William McKinnon and Leanne Homer in the trials office. When you return your questionnaire all information that links your answers with your name will be removed. This means that your answers are anonymised and it is these anonymised answers which will be looked at to see which treatment is best for women with fibroids. Neither William or Leanne will be involved in the data analysis so there is no way any of your answers will ever be linked to your name.
Can I contact someone directly to ask about the trial?
Of course. You can contact William McKinnon, the Trial Co-ordinator, who will answer any questions you may have. You can contact William at anytime by e-mail or by telephone on 0121 414 8335 during office hours.
How do I join the FEMME trial?
FEMME is running at numerous NHS sites throughout the UK. Click here to find out if there is a centre near you. If not, then contact the FEMME office to see if one will be opening soon.
If there is a centre open near you then the name of the doctor in charge of the trial at that site is given alongside the site's name. To be considered for the FEMME trial then please ask your GP for a referral to the doctor at the site where you'd like to receive your treatment.
Can I change my mind during the trial?
If you change your mind you can leave the FEMME trial at any time. You don't have to give a reason and if you withdraw your ongoing healthcare will not be affected.
If you no longer wish to take part in FEMME then simply tell the doctor or nurse looking after you, or contact William McKinnon at anytime by e-mail or by telephone on 0121 414 8335 during office hours.