title: A randomised trial of treating fibroids with either embolisation or myomectomy to measure the effect on quality of life among women wishing to avoid hysterectomy (the FEMME study): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Uterine fibroids are the most common tumour in women of reproductive age. By the time they are 50-years-old around 80% of women will have developed one. Of these, around half will experience symptoms which will impact negatively on their quality of life. Hysterectomy is the traditional treatment for women with symptomatic fibroids. For women who do not wish to undergo a hysterectomy, two invasive treatments are commonly available: myomectomy or uterine artery embolization (UAE).
  
  
  METHODS
  FEMME is a pragmatic, randomised, open, multi-centre trial examining the quality of life menstruating women with symptomatic fibroids experience after treatment with UAE or myomectomy.
  
  
  METHODS
  After providing informed consent, 216 women with symptomatic fibroids from 43 NHS Hospital Trusts and Health Boards across the United Kingdom will undergo randomisation by a centralised computer system to treatment by either UAE or myomectomy. A minimisation algorithm will be used in order to balance the groups with respect to the following three parameters: the longest dimension of the largest fibroid, the number of fibroids present, and whether the woman currently desires pregnancy.Using validated questionnaires the women's quality of life will be compared between groups at six months, one year, two years and four years post-procedure, taking into account pre-procedure scores. An economic evaluation will be conducted alongside the trial to determine the cost-effectiveness of UAE compared with myomectomy.Validated diaries will also be used to compare menstrual blood loss at the same time-points. The plasma concentration of Anti-Müllerian hormone (AMH), which will act as a proxy measurement of ovarian reserve, will be recorded before the woman has her procedure and then again at six weeks, six months, and twelve months afterwards. Re-intervention rates will be recorded.
  
  
  CONCLUSIONS
  The FEMME trial's primary outcome is the quality of life women with symptomatic uterine fibroids experience two years after they have been treated with either UAE or myomectomy, as measured by the disease-specific Uterine Fibroid Symptom Quality-of-Life (UFS-QoL) questionnaire.
  
  
  BACKGROUND
  Current Controlled Trials registration number: ISRCTN70772394, registered on 2 March 2013.
authors.forename: Klim
authors.initials: K
authors.lastname: McPherson
authors.forename: Isaac
authors.initials: I
authors.lastname: Manyonda
authors.forename: Mary-Ann
authors.initials: MA
authors.lastname: Lumsden
authors.forename: Anna-Maria
authors.initials: AM
authors.lastname: Belli
authors.forename: Jon
authors.initials: J
authors.lastname: Moss
authors.forename: Olivia
authors.initials: O
authors.lastname: Wu
authors.forename: Lee
authors.initials: L
authors.lastname: Middleton
authors.affiliation: Birmingham Clinical Trials Unit, University of Birmingham, Birmingham B15 2TT, UK. j.p.daniels@bham.ac.uk.
authors.forename: Jane
authors.initials: J
authors.lastname: Daniels
mesh_terms: D054304:Anti-Mullerian Hormone / Q000097:blood; D015415:Biomarkers / Q000097:blood; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D005260:Female; D017048:Health Care Costs; D006801:Humans; D007044:Hysterectomy / Q000009:adverse effects*; D007889:Leiomyoma / Q000175:diagnosis / Q000191:economics / Q000503:physiopathology / Q000628:therapy*; D065851:Ovarian Reserve; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D055357:Uterine Artery Embolization / Q000009:adverse effects / Q000191:economics; D063186:Uterine Myomectomy / Q000009:adverse effects / Q000191:economics; D014594:Uterine Neoplasms / Q000175:diagnosis / Q000191:economics / Q000503:physiopathology / Q000628:therapy*
chemical_list: D015415:Biomarkers; D054304:Anti-Mullerian Hormone