Advertisement

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

Published:January 04, 2017DOI:https://doi.org/10.1016/j.ajog.2016.12.177

      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

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to American Journal of Obstetrics & Gynecology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Gliklich R.E.
        • Leavy M.B.
        • Velentgas P.
        • et al.
        Identification of future research needs in the comparative management of uterine fibroid disease: a report on the priority-setting process, preliminary data analysis, and research plan. Effective health care program research report no. 31.
        Agency for Healthcare Research and Quality, Rockville (MD)2011
        • Pinto I.
        • Chimeno P.
        • Romo A.
        • et al.
        Uterine fibroids: uterine artery embolization versus abdominal hysterectomy for treatment: a prospective, randomized, and controlled clinical trial.
        Radiology. 2003; 226: 425-431
        • Mara M.
        • Fucikova Z.
        • Maskova J.
        • Kuzel D.
        • Haakova L.
        Uterine fibroid embolization versus myomectomy in women wishing to preserve fertility: preliminary results of a randomized controlled trial.
        Eur J Obstet Gynecol Reprod Biol. 2006; 126: 226-233
        • Edwards R.D.
        • Moss J.G.
        • Lumsden M.A.
        • et al.
        Committee of the Randomized Trial of Embolization versus Surgical Treatment for Fibroids. Uterine-artery embolization versus surgery for symptomatic uterine fibroids.
        N Engl J Med. 2007; 356: 360-370
        • Levens E.D.
        • Potlog-Nahari C.
        • Armstrong A.Y.
        • et al.
        CDB-2914 for uterine leiomyomata treatment: a randomized controlled trial.
        Obstet Gynecol. 2008; 111: 1129-1136
        • Hald K.
        • Noreng H.J.
        • Istre O.
        • Klow N.E.
        Uterine artery embolization versus laparoscopic occlusion of uterine arteries for leiomyomas: long-term results of a randomized comparative trial.
        J Vasc Interv Radiol. 2009; 20: 1303-1310
        • van der Kooij S.M.
        • Hehenkamp W.J.
        • Volkers N.A.
        • Birnie E.
        • Ankum W.M.
        • Reekers J.A.
        Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids: 5-year outcome from the randomized EMMY trial.
        Am J Obstet Gynecol. 2010; 203: 105.e1-105.e13
        • Parsanezhad M.E.
        • Azmoon M.
        • Alborzi S.
        • et al.
        A randomized, controlled clinical trial comparing the effects of aromatase inhibitor (letrozole) and gonadotropin-releasing hormone agonist (triptorelin) on uterine leiomyoma volume and hormonal status.
        Fertil Steril. 2010; 93: 192-198
        • Sayed G.H.
        • Zakherah M.S.
        • El-Nashar S.A.
        • Shaaban M.M.
        A randomized clinical trial of a levonorgestrel-releasing intrauterine system and a low-dose combined oral contraceptive for fibroid-related menorrhagia.
        Int J Gynaecol Obstet. 2011; 112: 126-130
        • Wang X.
        • Qin J.
        • Wang L.
        • Chen J.
        • Chen W.
        • Tang L.
        Effect of high-intensity focused ultrasound on sexual function in the treatment of uterine fibroids: comparison to conventional myomectomy.
        Arch Gynecol Obstet. 2013; 288: 851-858
        • Dickersin K.
        • Munro M.
        • Langenberg P.
        • et al.
        Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding Research Group. Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB): design and methods.
        Control Clin Trials. 2003; 24: 591-609
        • Varner R.E.
        • Ireland C.C.
        • Summitt Jr., R.L.
        • et al.
        • Ms Research Group
        Medicine or Surgery (Ms): a randomized clinical trial comparing hysterectomy and medical treatment in premenopausal women with abnormal uterine bleeding.
        Control Clin Trials. 2004; 25: 104-118
        • Dickersin K.
        • Munro M.G.
        • Clark M.
        • et al.
        Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB) Research Group. Hysterectomy compared with endometrial ablation for dysfunctional uterine bleeding: a randomized controlled trial.
        Obstet Gynecol. 2007; 110 (Erratum in: Obstet Gynecol 2008;112(2 Pt 1):381): 1279-1289
        • Lukes A.S.
        • Moore K.A.
        • Muse K.N.
        • et al.
        Tranexamic acid treatment for heavy menstrual bleeding: a randomized controlled trial.
        Obstet Gynecol. 2010; 116: 865-875
        • Bouwsma E.V.
        • Hesley G.K.
        • Woodrum D.A.
        • et al.
        Comparing focused ultrasound and uterine artery embolization for uterine fibroids: rationale and design of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) trial.
        Fertil Steril. 2011; 96: 704-710
        • AbdElmagied A.M.
        • Vaughan L.E.
        • Weaver A.L.
        • et al.
        Fibroid interventions: reducing symptoms today and tomorrow: extending generalizability by using a comprehensive cohort design with a randomized controlled trial.
        Am J Obstet Gynecol. 2016; 215: 338.e1-338.e18
        • Vist G.E.
        • Hagen K.B.
        • Devereaux P.J.
        • Bryant D.
        • Kristoffersen D.T.
        • Oxman A.D.
        Systematic review to determine whether participation in a trial influences outcome.
        BMJ. 2005; 330: 1175
        • Spies J.B.
        • Coyne K.
        • Guaou N.
        • Boyle D.
        • Skyrnarz-Murphy K.
        • Gonzalves S.M.
        The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata.
        Obstet Gynecol. 2002; 99: 290-300
        • Pocock S.J.
        • Simon R.
        Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial.
        Biometrics. 1975; 31: 103-115
        • Goodwin S.C.
        • Spies J.B.
        Uterine fibroid embolization.
        N Engl J Med. 2009; 361: 690-697
        • Gorny K.R.
        • Woodrum D.A.
        • Brown D.L.
        • et al.
        Magnetic resonance-guided focused ultrasound of uterine leiomyomas: review of a 12-month outcome of 130 clinical patients.
        J Vasc Interv Radiol. 2011; 22: 857-864
        • Spies J.B.
        • Spector A.
        • Roth A.R.
        • Baker C.M.
        • Mauro L.
        • Murphy-Skrynarz K.
        Complications after uterine artery embolization for leiomyomas.
        Obstet Gynecol. 2002; 100: 873-880
        • American College of Obstetricians and Gynecologists
        Quality assessment and improvement in obstetrics and gynecology.
        American College of Obstetricians and Gynecologists, Washington (DC)1994: 16
        • McNutt L.A.
        • Wu C.
        • Xue X.
        • Hafner J.P.
        Estimating the relative risk in cohort studies and clinical trials of common outcomes.
        Am J Epidemiol. 2003; 157: 940-943
        • Goodwin S.C.
        • Spies J.B.
        • Worthington-Kirsch R.
        • et al.
        Fibroid Registry for Outcomes Data (FIBROID) Registry Steering Committee and Core Site Investigators. Uterine artery embolization for treatment of leiomyomata: long-term outcomes from the FIBROID Registry.
        Obstet Gynecol. 2008; 111: 22-33
        • Stewart E.A.
        • Rabinovici J.
        • Tempany C.M.
        • et al.
        Clinical outcomes of focused ultrasound surgery for the treatment of uterine fibroids.
        Fertil Steril. 2006; 85 (Erratum in: Fertil Steril 2006;85:1072): 22-29
        • Stewart E.A.
        Clinical practice. Uterine fibroids.
        N Engl J Med. 2015; 372: 1646-1655
        • Fergusson R.J.
        • Lethaby A.
        • Shepperd S.
        • Farquhar C.
        Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding.
        Cochrane Database Syst Rev. 2013; 29: CD000329
        • Kongwattanakul K.
        • Khampitak K.
        Comparison of laparoscopically assisted vaginal hysterectomy and abdominal hysterectomy: a randomized controlled trial.
        J Minim Invasive Gynecol. 2012; 19: 89-94
        • Miller E.C.
        • McIsaac D.I.
        • Chaput A.
        • Antrobus J.
        • Shenassa H.
        • Lui A.
        Increased postoperative day one discharges after implementation of a hysterectomy enhanced recovery pathway: a retrospective cohort study.
        Can J Anaesth. 2015; 62: 451-460
        • Lenihan Jr., J.P.
        • Kovanda C.
        • Cammarano C.
        Comparison of laparoscopic-assisted vaginal hysterectomy with traditional hysterectomy for cost-effectiveness to employers.
        Am J Obstet Gynecol. 2004; 190: 1714-1720
        • Brandsborg B.
        • Dueholm M.
        • Nikolajsen L.
        • Kehlet H.
        • Jensen T.S.
        A prospective study of risk factors for pain persisting 4 months after hysterectomy.
        Clin J Pain. 2009; 25: 263-268
        • Learman L.A.
        • Kuppermann M.
        • Gates E.
        • Gregorich S.E.
        • Lewis J.
        • Washington A.E.
        Predictors of hysterectomy in women with common pelvic problems: a uterine survival analysis.
        J Am Coll Surg. 2007; 204: 633-641