FEMME trial

FEMME is an NIHR funded clinical trial which is designed to measure the changes in the quality of life women experience when their fibroids are treated by either myomectomy or uterine artery embolisation.

We’d love you to be part of FEMME. If you’d like to find out more about FEMME please download our one page summary or full protocol.

Don’t forget to register your interest with us, either by email (w.mckinnon@bham.ac.uk) or call us on +44 (0)121 414 8335.

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 will follow the progress of 650 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

 

 

  FEMME logo

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