FEMME trial

 

FEMME is an NIHR funded clinical trial which is designed to track the changes in the quality of life experienced by women with uterine fibroids.

With your help, recruitment to FEMME is now complete and we’re in the follow-up phase. If you are taking part in FEMME then please do continue to complete and return your questionnaires letting us know how you feel about your life now.

If you are taking part in FEMME then please do let us know your address so we can continue to send you the questionnaires. If you can’t find the questionnaires then please contact the trials office who will happily send you replacements. If you prefer, you can download copies of the follow-up questionnaires from the ‘For Trial Participants’ link on the left. 

We would like to know how you feel no matter what has happened to you, so please do fill in the questionnaires and send them back to us even if you did not have any treatment, you have had a different or another treatment, or are not having periods.

Your thoughts on how you feel about your life are important and will make a difference to the treatments available to women with fibroids in the future.

If you have any questions about FEMME then please do feel free to contact Bill, the Trial co-ordinator, either by email (w.mckinnon@bham.ac.uk) or telephone on 0121 414 8335. Bill will be delighted to talk with you and answer any questions you may have.

Thank you, for all your help in making FEMME the success it has been so far – we couldn’t have come this far without you!

 

Background

Fibroids are the most common benign tumor in women and by the time they are fifty years old around four out of five women will have had a fibroid.

Of the women who develop fibroids, around half will experience symptoms that will adversely affect their quality of life. On top of this, some women with fibroids may experience difficulty in conceiving, and if they do conceive they are at a higher risk of miscarriage compared with women of the same age without fibroids. As many women are starting a family later in their life, fibroids are a growing problem.

What is the study about?

Within the NHS there are three treatments that are routinely used to treat fibroids:

  • Hysterectomy (surgery to remove the womb),
  • Myomectomy (surgery to remove the fibroid)

and

  • Uterine Artery Embolisation or UAE (where the blood supply to the artery is blocked).

With many women now looking for an alternative to hysterectomy, myomectomy and UAE are growing in favour. Gynaecologists will decide what is the best treatment for  fibroids depending on their size, how many fibroids there are and where they are in the womb. However it may be that gynaecologists think that the fibroids will respond equally well to myomectomy and UAE.

With both myomectomy and UAE having their own risks and potential side effects, many health care professionals are uncertain which is the best treatment to offer to women who wish to retain their wombs abd this is why the research arm of the NHS have funded the FEMME trial.

FEMME is following the progress of 250 women over four years. Half of the women will be randomly allocated to have a myomectomy and the other half will receive a UAE. Using questionnaires that reflect how well women feel, FEMME will record the quality of life women say they have after they have undergone a myomectomy and this will be compared with the quality of life women report after having UAE.

FEMME is also going to measure how each procedure changes how much blood is lost as well examining if UAE and myomectomy change the level of ovarian hormones associated with fertility.

With FEMME we will measure the effectiveness of myomectomy and UAE and to help us do this information on any follow up procedures that women may have to undergo will also be collected.

Who can enter?

FEMME is open to:

  • menstruating women
  • aged over 18 years old
  • whose quality of life is adversely affected by uterine fibroids
  • who wish to retain their wombs

and

  • whose gynaecologists believe that their fibroids will respond equally well to UAE or myomectomy