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      A New Paradigm for Uterine Fibroid Treatment: Transcervical, Intrauterine Sonography-Guided Radiofrequency Ablation of Uterine Fibroids with the Sonata System

      review-article
      1 , 2 ,
      Current Obstetrics and Gynecology Reports
      Springer US
      Fibroids, Radiofrequency ablation, Sonata, Intrauterine sonography

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          Abstract

          Purpose of Review

          This article provides the current evidence related to transcervical radiofrequency ablation of uterine fibroids under integrated intrauterine sonography guidance (the Sonata System).

          Recent Findings

          Published data on the treatment of fibroids with the Sonata System has demonstrated significant median reductions in total (73.3%) and perfused (73.3%) uterine fibroid volume, menstrual bleeding (72.3%), symptom severity (62.5%), and improvements in health-related quality of life (127%) at 12 months post-ablation. A clinical trial under an FDA Investigational Device Exemption is in progress.

          Summary

          The Sonata System is a promising treatment modality for uterine fibroids. As an incisionless, minimally invasive treatment that does not require general anesthesia or hospitalization, it has the potential for redefining the current paradigm for management of symptomatic fibroids.

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          Most cited references35

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          Hysterectomy rates in the United States 1990-1997.

          To assess hysterectomy rates, type of hysterectomy, and other factors associated within the United States from 1990-1997. A descriptive statistical analysis of national discharge data was undertaken. Data from the nationwide Inpatient Sample of the Healthcare Cost and Utilization Project (from which national estimates are generated based on a 20% stratified sample of US community hospitals) were used for the years 1990-1997. All women who underwent hysterectomy were identified using International Classification of Diseases, 9th Revision, Clinical Modification, procedure codes. Outcome measures included rate, type of hysterectomy, age of patients, length of stay, total hospital charges, and diagnostic categories. Rates of hysterectomy have not changed significantly over the years from 1990-1997. Rates for hysterectomy in 1990 were 5.5 per 1000 women and increased slightly by 1997 to 5.6 per 1000 women. The type of hysterectomy has changed, with laparoscopic hysterectomy accounting for 9.9% of cases by 1997, with a concomitant decline in abdominal hysterectomy but no substantial change in vaginal hysterectomy rates. Length of stay decreased and total charges increased for all types of hysterectomy. Vaginal hysterectomy and laparoscopic hysterectomy are associated with shorter length of stay than abdominal hysterectomy. Abdominal hysterectomy is the most common procedure (63.0% in 1997). The majority of hysterectomies are abdominal, and the most common indication is uterine fibroids. The introduction of alternative techniques for controlling abnormal uterine bleeding such as endometrial ablation has not had an impact on hysterectomy rates, and there has only been a limited uptake of laparoscopic approaches.
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            The burden of uterine fibroids in five European countries.

            To quantify the burden of uterine fibroids (UF) on health-related quality of life (HRQOL) and work productivity in a general population of women. Women diagnosed with or experiencing UF-related symptoms living in five Western European countries (France, Germany, Italy, Spain, and the United Kingdom) were identified through a cross-sectional Internet-based survey. The following parameters and outcomes of interest were captured and analysed: patient history and demographics, treatment and diagnosis patterns, symptom severity and HRQOL, work productivity and activity impairment, and disease or symptom-related health care resource use for the past year (e.g., provider visits, hospitalisation). This analysis included 1756 women (France, 358; Germany, 345; Italy, 351; Spain, 352; United Kingdom, 350). Prevalence of a diagnosis of UF ranged from 11.7% to 23.6%, and that of undiagnosed bleeding symptoms from 14.7% to 24.6% across the five countries. Between 9.0% and 32.5% of women waited > or =5 years before seeking treatment for UF. Mean UFS-QOL symptom severity scores ranged from 24.7 (95% confidence interval [CI], 21.1-28.3) to 37.6 (95% CI, 32.2-43.0; P<0.001), suggesting mild to moderate severity. Mean UFS-QOL scores ranged from 59.2 (95% CI, 54.2-64.2) to 69.7 (95% CI, 66.5-73.0; P=0.002), suggesting moderate impairment. In pooled analyses, absenteeism was reported by 32.7% of employed women with a diagnosis of UF. Overall worker productivity was reduced by 36.1% and general activity was impaired by 37.9%. UF are common in women residing in Western Europe. They are associated with impairment of HRQOL and productivity. A substantial number of women delay seeking medical help. Encouraging symptomatic women to seek help and treatment earlier may benefit women by improving their HRQOL and may also benefit society through enhanced worker productivity. Copyright 2010 Elsevier Ireland Ltd. All rights reserved.
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              Sustained relief of leiomyoma symptoms by using focused ultrasound surgery.

              To assess several measures of the long-term outcome of magnetic resonance-guided focused ultrasound surgery for symptomatic uterine leiomyomata. Data on 359 women completing 24-month follow-up in all clinical trials of magnetic resonance-guided focused ultrasound surgery for uterine leiomyomata were analyzed. Quality of life outcomes, measured by the symptom severity score of the Uterine Fibroid Symptoms Quality Of Life Questionnaire were assessed for 24 months after treatment. Clinical endpoints, including uterine shrinkage, the need for additional leiomyoma treatment, and the time to additional leiomyoma treatment, were all assessed. The nonperfused volume ratio after treatment, calculated from the gadolinium-enhanced magnetic resonance imaging after treatment and the best measure of tissue necrosis after treatment, was used to assess outcome based on completeness of leiomyoma ablation. Women undergoing magnetic resonance-guided focused ultrasound surgery for symptomatic uterine leiomyomata have durable symptom relief, as measured by the symptom severity score at 24 months, with significantly greater improvement with more complete ablation (P<.001). Survival analysis demonstrates a significant reduction in the percentage of women undergoing additional leiomyoma treatment (P=.001) in women in the high nonperfused volume group. The mean shrinkage and mean residual nonperfused volume ratio are both significantly above zero at 6 months in the high nonperfused volume group (P<.001). The incidence of adverse events is low. However, for women with minimal treatment, the risk of additional procedures is high. Magnetic resonance-guided focused ultrasound surgery is an effective treatment for uterine leiomyomata and results in sustained symptomatic relief. III.
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                Author and article information

                Contributors
                215.882.3420 , dtoub@gynesonics.com
                Journal
                Curr Obstet Gynecol Rep
                Curr Obstet Gynecol Rep
                Current Obstetrics and Gynecology Reports
                Springer US (New York )
                2161-3303
                15 February 2017
                15 February 2017
                2017
                : 6
                : 1
                : 67-73
                Affiliations
                [1 ]Gynesonics, Inc, 301 Galveston Drive, Redwood City, CA 94063 USA
                [2 ]ISNI 0000 0001 2181 6998, GRID grid.239276.b, Department of Obstetrics and Gynecology, , Albert Einstein Medical Center, ; 5501 Old York Road, Philadelphia, PA 19141 USA
                Article
                194
                10.1007/s13669-017-0194-2
                5350207
                16824d2d-d36b-4d3f-8f22-b80b5816b70e
                © The Author(s) 2017

                Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

                History
                Categories
                Emerging and Pipeline Technologies in Ob/Gyn (M Levie, Section Editor)
                Custom metadata
                © Springer Science+Business Media New York 2017

                Obstetrics & Gynecology
                fibroids,radiofrequency ablation,sonata,intrauterine sonography
                Obstetrics & Gynecology
                fibroids, radiofrequency ablation, sonata, intrauterine sonography

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