Two common treatments for uterine fibroids—surgical removal and a minimally invasive procedure that cuts off their blood supply—are being directly compared for the first time in a large UK trial. Uterine fibroids are non-cancerous growths that affect roughly half of women of reproductive age, causing heavy bleeding, pain, and pressure that can severely disrupt daily life. While both myomectomy (surgery) and uterine artery embolisation (UAE, a radiology procedure) improve symptoms, doctors lack robust comparative data on which works better for quality of life, recovery time, and fertility. The FEMME trial will randomise 216 women across more than 30 UK hospitals to one treatment or the other, tracking their quality of life with a disease-specific questionnaire at two years, plus menstrual bleeding, pregnancy outcomes, and side effects over four years. If the trial shows one treatment clearly outperforms the other, it could change clinical guidelines and help women make informed choices about a procedure that affects their ability to conceive and their long-term wellbeing. The economic analysis will also tell the NHS whether one option offers better value. This is applied clinical research with a direct, near-term impact on patient care.
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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.
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