Background
Uterine fibroids are a common problem for reproductive-aged women, yet little comparative
effectiveness research is available to guide treatment choice. Uterine artery embolization
and magnetic resonance imaging–guided focused ultrasound surgery are minimally invasive
therapies approved by the US Food and Drug Administration for treating symptomatic
uterine fibroids. The Fibroid Interventions: Reducing Symptoms Today and Tomorrow
study is the first randomized controlled trial to compare these 2 fibroid treatments.
Objective
The objective of the study was to summarize treatment parameters and compare recovery
trajectory and adverse events in the first 6 weeks after treatment.
Study Design
Premenopausal women with symptomatic uterine fibroids seen at 3 US academic medical
centers were enrolled in the randomized controlled trial (n = 57). Women meeting identical
criteria who declined randomization but agreed to study participation were enrolled
in a nonrandomized parallel cohort (n = 34). The 2 treatment groups were analyzed
by using a comprehensive cohort design. All women undergoing focused ultrasound and
uterine artery embolization received the same postprocedure prescriptions, instructions,
and symptom diaries for comparison of recovery in the first 6 weeks. Return to work
and normal activities, medication use, symptoms, and adverse events were captured
with postprocedure diaries. Data were analyzed using the Wilcoxon rank sum test or
χ2 test. Multivariable regression was used to adjust for baseline pain levels and fibroid
load when comparing opioid medication, adverse events, and recovery time between treatment
groups because these factors varied at baseline between groups and could affect outcomes.
Adverse events were also collected.
Results
Of 83 women in the comprehensive cohort design who underwent treatment, 75 completed
postprocedure diaries. Focused ultrasound surgery was a longer procedure than embolization
(mean [SD], 405 [146] vs 139 [44] min; P <.001). Of women undergoing focused ultrasound (n = 43), 23 (53%) underwent 2 treatment
days. Immediate self-rated postprocedure pain was higher after uterine artery embolization
than focused ultrasound (median [interquartile range], 5 [1–7] vs 1 [1–4]; P = .002). Compared with those having focused ultrasound (n = 39), women undergoing embolization
(n = 36) were more likely to use outpatient opioid (75% vs 21%; P < .001) and nonsteroidal antiinflammatory medications (97% vs 67%; P < .001) and to have a longer median (interquartile range) recovery time (days off work,
8 [6–14] vs 4 [2–7]; P < .001; days until return to normal, 15 [10–29] vs 10 [10–15]; P = .02). There were no significant differences in the incidence or severity of adverse
events between treatment arms; 86% of adverse events (42 of 49) required only observation
or nominal treatment, and no events caused permanent sequelae or death. After adjustment
for baseline pain and uterine fibroid load, uterine artery embolization was still
significantly associated with higher opioid use and longer time to return to work
and normal activities (P < .001 for each). Results were similar when restricted to the randomized controlled trial.
Conclusion
Women undergoing uterine artery embolization have longer recovery times and use more
prescription medications, but women undergoing focused ultrasound have longer treatment
times. These findings were independent of baseline pain levels and fibroid load.
Key words
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Article Info
Publication History
Published online: January 04, 2017
Accepted:
December 29,
2016
Received in revised form:
November 21,
2016
Received:
September 2,
2016
Footnotes
The contents of this manuscript are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.
This study was supported by grants RC1HD063312 and R01HD060503 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health and National Institutes of Health/National Center for Research Resources/Clinical and Translational Science Awards grant UL1 RR024150. InSightec (Tirat Carmel, Israel) provided support for payment of treatment costs for some study participants but had no role in study design or conduct and review of data, abstracts, or manuscript.
E.A.S. reports consulting from AbbVie, Allergan, Bayer, Gynesonics, Astellas, and Viteava Pharmaceuticals related to uterine fibroids; Welltwigs related to infertility; and GlaxoSmithKline related to adenomyosis. G.K.H., K.R.G., T.M.P., and A.N. report grants from InSightec outside the submitted work. A.M.A. reports fellowship funding from the Egyptian Ministry of Higher Education and Scientific Research. P.C.L. reports grants from BioSpecifics Technologies Corp outside the submitted work and a patent pending (Treatment Method and Product for Uterine Fibroids using Purified Collagenase). V.L.J. reports grants from Halt Medical outside the submitted work. The other authors have nothing to report.
Cite this article as: Barnard EP, AbdElmagied AM, Vaughan LE, et al. Periprocedural outcomes comparing fibroid embolization and focused ultrasound: a randomized controlled trial and comprehensive cohort analysis. Am J Obstet Gynecol 2017;216:500.e1-11.
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