FEMME
PubMed
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Clinical Question
In women with symptomatic uterine fibroids who desire to preserve their uterus and have not responded to medical treatment, does myomectomy offer better fibroid-related quality of life outcomes compared to uterine-artery embolization?
Bottom Line
Among women with symptomatic uterine fibroids, myomectomy resulted in a significantly better fibroid-related quality of life at 2 years compared to uterine-artery embolization. The improvement in health-related quality-of-life scores was observed after both procedures, but myomectomy showed a greater benefit. Perioperative and postoperative complications were low for both myomectomy and uterine-artery embolization.
Major Points
A multicenter, randomized, open-label trial (A Randomized Trial of Treating Fibroids with Either Embolization or Myomectomy to Measure the Effect on Quality of Life Among Women Wishing to Avoid Hysterectomy), investigated therapeutic options for women with symptomatic uterine fibroids who desired to preserve their uterus and had not responded to medical treatment. The study, conducted across 29 hospitals in the United Kingdom, included 254 women who were randomly assigned to undergo either myomectomy (n=127) or uterine-artery embolization (n=127). Procedural options for myomectomy encompassed open abdominal, laparoscopic, or hysteroscopic approaches. The primary outcome was fibroid-related quality of life at 2 years, assessed using the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire, with myomectomy demonstrating a significantly better fibroid-related quality of life compared to uterine-artery embolization.
In terms of the primary outcome, the mean scores on the health-related quality-of-life domain of the UFS-QOL questionnaire at 2 years were substantially higher in the myomectomy group (84.6±21.5) compared to the uterine-artery embolization group (80.0±22.0). The improvement in health-related quality of life with myomectomy was statistically significant, with a mean adjusted difference of 8.0 points (P=0.01). Sensitivity analyses, including adjustments for missing responses, consistently supported the finding of myomectomy's superiority in enhancing fibroid-related quality of life. Notably, despite improvements observed in both groups, myomectomy demonstrated a greater magnitude of benefit, emphasizing its effectiveness in addressing the symptomatic burden of uterine fibroids.
The study's secondary outcomes further supported the superiority of myomectomy. Health-related quality-of-life scores were consistently higher after myomectomy compared to uterine-artery embolization at 6 months and 1 year. Additionally, the UFS-QOL symptom severity domain favored myomectomy, with significant mean differences at 6 months and 2 years. Patient-reported outcomes, such as the percentage of women recommending the procedure and willingness to undergo the procedure again, were also higher in the myomectomy group at 2 years. The analysis of adverse events and procedural complications indicated low incidences in both groups, with myomectomy having comparable safety profiles to uterine-artery embolization. Overall, the FEMME trial demonstrated that myomectomy, across various approaches, is associated with superior fibroid-related quality of life outcomes compared to uterine-artery embolization in women with symptomatic uterine fibroids who wish to avoid hysterectomy.
No guidelines have been published that reflect the results of this trial.
Design
- Trial type: Randomized, multicenter trial
- N=254 patients randomized
- Myomectomy arm: n=127
- Uterine-artery embolization arm: n=127
- Setting: 29 hospitals in the United Kingdom
- Enrollment: February 6, 2012, to May 21, 2015
- Mean follow-up: 2 years
- Analysis: Intention-to-treat
- Primary outcome: Fibroid-related quality of life at 2 years
Population
Inclusion Criteria
- Women older than 18 years
- Premenopausal
- Not pregnant
- Symptomatic fibroids suitable for myomectomy or uterine-artery embolization
Exclusion Criteria
- Substantial adenomyosis
- Suspected or diagnosed cancer
- Recent or ongoing pelvic inflammatory disease
- Previous open abdominal myomectomy or uterine-artery embolization
Baseline Characteristics
Demographic Characteristics: Uterine-Artery Embolization vs. Myomectomy
- Age and Race/Ethnicity:
- Uterine-Artery Embolization: Mean age of 40.2 years (±6.55);
- White: 46%, Black: 38%, South Asian: 8%, Mixed: 5%, Other: 3%
- Myomectomy: Mean age of 42.7 years (±6.4);
- White: 45%, Black: 43%, South Asian: 4%, Mixed: 6%, Other: 2%
- Uterine-Artery Embolization: Mean age of 40.2 years (±6.55);
- Body Mass Index (BMI):
- Uterine-Artery Embolization: Mean BMI of 28.2 (±6.2); Data missing for 6%
- Myomectomy: Mean BMI of 28.1 (±5.3); Data missing for 3%
- Desire for Pregnancy:
- Uterine-Artery Embolization: 48%
- Myomectomy: 48%
- Parity and Gravidity:
- Uterine-Artery Embolization: Median parity of 0 (IQR: 0–1); Median gravidity of 1 (IQR: 0–2)
- Myomectomy: Median parity of 1 (IQR: 0–2); Median gravidity of 2 (IQR: 0–3)
- Fibroid Assessment:
- Imaging: Uterine-Artery Embolization - MRI (70%), Ultrasonography (28%); Myomectomy - MRI (78%), Ultrasonography (21%)
- Location of Largest Fibroid: Uterine-Artery Embolization - Muscle wall (58%), Subserosa (24%); Myomectomy - Muscle wall (64%), Subserosa (17%)
- Size and Volume of Fibroids:
- Longest Dimension of Largest Fibroid: Uterine-Artery Embolization - ≤7 cm (50%), >7 cm (50%); Myomectomy - ≤7 cm (50%), >7 cm (50%)
- Largest Fibroid Volume: Uterine-Artery Embolization - Mean of 436 cm³; Data missing for 2%
- Uterine Volume: Uterine-Artery Embolization - Mean of 1170 cm³; Data missing for 7%
- Surgical and Medication History:
- Previous Abdominal Surgery: Uterine-Artery Embolization - Cesarean section (9%), Laparoscopy (15%); Myomectomy - Cesarean section (15%), Laparoscopy (12%)
- Contraceptive or Hormonal Treatments: Uterine-Artery Embolization - 59%; Myomectomy - 57%
Interventions
- Randomized to myomectomy or uterine-artery embolization
- Procedures included open abdominal, laparoscopic, or hysteroscopic myomectomy
- Specific embolic agent chosen at the discretion of interventional radiologist for uterine-artery embolization
- Gonadotropin-releasing hormone analogue or ulipristal acetate administered before myomectomy if deemed essential.
Outcomes
Comparisons are intensive therapy vs. standard therapy.
Primary Outcomes
- Fibroid-related quality of life at 2 years (UFS-QOL)
- Myomectomy: 84.6±21.5
- Uterine-artery embolization: 80.0±22.0
- Mean adjusted difference (complete case analysis): 8.0 points (P=0.01)
Secondary Outcomes
- Health-related quality-of-life domain at 6 months and 1 year
- Myomectomy consistently higher than uterine-artery embolization
- Symptom severity domain of UFS-QOL at 6 months and 2 years
- Favoring myomectomy with mean differences of −6.1 and −3.8 points
- Percentage of women recommending the procedure at 2 years
- Myomectomy: 93%, Uterine-artery embolization: 84%
- Percentage of women willing to undergo the procedure again at 2 years
- Myomectomy: 78%, Uterine-artery embolization: 74%
Subgroup Analysis
Prespecified subgroup analysis showed consistent benefits of myomectomy over uterine-artery embolization in various categories.
Adverse Events
- Intraoperative complications
- Low incidence in both groups
- Additional fibroid-related procedures at 2 years
- Myomectomy: 7%
- Uterine-artery embolization: 16%
- Perioperative and postoperative complications
- Myomectomy: 29%, Uterine-artery embolization: 24%
- Length of hospital stay
- Myomectomy: 4 days, Uterine-artery embolization: 2 days
Criticisms
19% of participants did not return the primary outcome questionnaire at 2 years. Lack of blinding might have influenced subjective outcomes reporting. Some participants did not receive the intervention to which they were randomly assigned.
Funding
Funded by the National Institute for Health Research Health Technology Assessment program; FEMME Current Controlled Trials number, ISRCTN70772394.
Further Reading
- Stewart EA, Cookson CL, Gandolfo RA, Schulze-Rath R. Epidemiology of uterine fibroids: a systematic review. BJOG 2017;124:1501-1512.
- Drayer SM, Catherino WH. Prevalence, morbidity, and current medical management of uterine leiomyomas. Int J Gynaecol Obstet 2015;131:117-122.
- Sundermann AC, Velez Edwards DR, Bray MJ, Jones SH, Latham SM, Hartmann KE. Leiomyomas in pregnancy and spontaneous abortion: a systematic review and meta-analysis. Obstet Gynecol 2017;130:1065-1072.
- Mara M, Maskova J, Fucikova Z, Kuzel D, Belsan T, Sosna O. Midterm clinical and first reproductive results of a randomized controlled trial comparing uterine fibroid embolization and myomectomy. Cardiovasc Intervent Radiol 2008;31:73-85.
- Manyonda IT, Bratby M, Horst JS, Banu N, Gorti M, Belli A-M. Uterine artery embolization versus myomectomy: impact on quality of life — results of the FUME (Fibroids of the Uterus: Myomectomy versus Embolization) Trial. Cardiovasc Intervent Radiol 2012;35:530-536.
- Gupta JK, Sinha A, Lumsden MA, Hickey M. Uterine artery embolization for symptomatic uterine fibroids. Cochrane Database Syst Rev 2012;5:CD005073-CD005073.