Periprocedural outcomes comparing fibroid embolization and focused ultrasound: a randomized controlled trial and comprehensive cohort analysis

Abstract

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 United States 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. (NCT00995878, clinicaltrials.gov) Objective 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 anti-inflammatory 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 returned 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% (42/49) of adverse events 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 lon...

The Focused Ultrasound Myoma Outcome Study (FUMOS); a retrospective cohort study on long-term outcomes of MR-HIFU therapy

“…Two studies compared MR-HIFU to UAE [17,31], and they reported lower reintervention rates and greater improvement in symptoms after UAE. However, the mean NPV% in both trials was below 50% [32]. More recent studies reported lower retreatment rates: 12.7% after MR-HIFU at 19.4 months (comparable to UAE) [13,28].…”

Partially randomised patient preference trials as an alternative design to randomised controlled trials: systematic review and meta-analyses

“…Fifty-eight partially RPPTs from 2005 onwards were found, of which 44 (including 24 873 patients) were eligible for at least basic data extraction (table 1), and 20 could be included in the meta-analyses (PRISMA flow chart, figure 1). 15–72 Exclusion reasons for the meta-analyses were: no availability of both treatment outcomes in the randomised and preference cohorts separately in 14 trials,15 16 18 19 23 24 27 30 31 34 39 41 42 63 no availability of SDs, which could also not be converted from other available data in five trials,21 29 49 52 62 and the number of events or the power of one or both cohort(s) was too low to perform separate randomised and preference analyses in five trials 25 28 40 55 72. The trials covered a wide range of clinical areas and interventions.…”

The Effect of Uterine Fibroids on Infertility: A Systematic Review

“…109 In comparison with UAE, MRgFUS has a shorter recovery time and less need for pain medication, but treatment times are longer. 123 A 2017 review of pregnancy outcomes and MRgFUS in the literature documents 102 pregnancy reports after this procedure. Forty-seven were full-term deliveries, 1 was a planned delivery at 36 weeks secondary to placenta previa, 21 were spontaneous abortions, 22 were elective terminations, and 11 were ongoing pregnancies.…”