Title: FEMME trial: Randomised trial of treating Fibroids with either Embolisation or MyoMectomy to measure the Effect on quality of life
Funder: Department of Health and Social Care

Abstract: Uterine fibroids are the most common benign tumour in women of reproductive age and increase in prevalence with age. Approximately half of women with fibroids experience significant symptoms which include heavy menstrual bleeding (HMB), abdominal pain and pressure, all of which impact significantly on quality of life. Myomectomy involves the surgical removal of the fibroids from the uterus. UAE is a minimally invasive interventional radiology procedure which involves occlusion of the blood vessels, reducing the blood supply to the fibroid and causing it to shrink. Both treatments improve quality of life and symptoms but have different recovery periods and risks of recurrence, yet there are little comparative randomised data. It is believed that fibroids may interfere with conception, but the relative impact of both treatments on fertility is unclear. The FEMME trial is a multicentre randomised trial comparing UAE with myomectomy for women with symptomatic fibroids wishing to retain their uterus. 216 eligible women will be randomised in a 1:1 ratio to myomectomy or embolisation. Participants will be recruited from over 30 UK hospitals by gynaecologists and interventional radiologists. The primary outcome of quality of life will be assessed by use of a disease specific questionnaire at two years. Effectiveness will also be assessed at 6 months and 1 and 4 years after treatment. Secondary outcomes include effect on menstrual bleeding, pregnancy outcomes, further treatment and adverse events. Ovarian function will be assessed by measuring the level of circulating AMH in a sub-group of women. Data on resource use will be collected to for an economic evaluation.

Lay abstract: Uterine fibroids are the most common benign tumours in women of reproductive age and become more common as women approach the menopause. Although many fibroids do not cause symptoms, around half of women with fibroids will experience symptoms which will have a negative impact on their quality of life. The symptoms of fibroids are quite wide ranging but can include heavy menstrual bleeding, pain and bloating. There is also some concern that fibroids could play a role in the decline in fertility as a woman gets older. In the past many women had completed their family when their fibroids became problematic and hence hysterectomy was an acceptable solution. Nowadays it is a less attractive option for many women. Two alternatives exist: the surgical removal of the fibroid (myomectomy) or reducing the blood supply to the fibroid by placing tiny beads into the blood vessels which supply them (uterine artery embolisation). Which is the best treatment to improve symptoms and the quality of life for women with fibroids is unknown. The impact of either treatment on the chances of conceiving and the risk of miscarriage has not been compared directly. On top of this both treatments may have their own drawbacks. Myomectomy is associated with adhesions in the uterus and embolisation might affect the working of the ovaries. Myomectomy is more invasive, more expensive and involves a longer hospital stay. The FEMME trial will recruit women from hospitals all across the UK. We intend to randomly assign these two treatments between women with fibroids who are experiencing symptoms which adversely affect their quality of life. Up to 216 women who agree to take part will after their operations. Information about the surgical technique, healthcare resources, complications, repeat surgeries, and any conceptions and pregnancy outcomes will be collected throughout the study. Women will also be asked to give blood before and afterwards to measure their reproductive hormone levels to gauge their fertility potential. Results of this trial will be used by gynaecologists and women to help them decide which is the best treatment for their uterine fibroids. Robust evidence will also be gained regarding the relative clinical and cost effectiveness of the two procedures. Embolisation is a less invasive procedure compared with myomectomy and hence if it can be shown to be equal to or better than myomectomy then many women may benefit from less trauma and less hospitalization. There are different approaches to myomectomy, depending on the location, number and size of the fibroid but the trial will not insist on one particular technique and leave it to the gynaecological surgeon to decide. Women who are hoping to conceive will not be excluded but will be counselled about the known risks of both treatments. The FEMME Trial Team comprises gynaecologists, interventional radiologists, trial experts and statisticians who have undertaken a significant amount of research in this area. Input from women who have had fibroids and treatment are important to ensure the trial is acceptable to participants and we are actively collaborating with several support groups.

Research activity codes: 6.4 SURGERY
Health categories: RENAL AND UROGENITAL