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      Clinical Performance of Radiofrequency Ablation for Treatment of Uterine Fibroids: Systematic Review and Meta-Analysis of Prospective Studies

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          Abstract

          Background: Radiofrequency ablation (RFA) has emerged as a safe and effective treatment option for women with symptomatic uterine fibroids and can be delivered by laparoscopic, transvaginal, or transcervical approaches. The evidence regarding typical patient outcomes with RFA has not previously been examined in a comprehensive fashion.

          Materials and Methods: We performed a systematic review of prospective studies for treatment of uterine fibroids with RFA. Main outcomes were procedure time, patient recovery metrics, change in fibroid volume, symptom severity score (SSS), health-related quality of life (HRQL), and reinterventions. Data were analyzed with random effects meta-analysis and metaregression.

          Results: We identified 32 articles of 1283 unique patients (median age: 42 years) treated with laparoscopic RFA (19 articles), transvaginal RFA (8 articles), or transcervical fibroid ablation (5 articles). Mean procedure time was 49 minutes, time to discharge was 8.2 hours, time to normal activities was 5.2 days, and time to return to work was 5.1 days. At 12 months follow-up, fibroid volume decreased by 66%, HRQL increased by 39 points, and SSS decreased by 42 points (all P < .001 versus baseline). The annual cumulative rate of reinterventions due to fibroid-related symptoms was 4.2%, 8.2%, and 11.5% through 3 years.

          Conclusions: RFA of uterine fibroids significantly reduces fibroid volume, provides significant durable improvements in fibroid-related quality of life, and is associated with favorable reintervention rates.

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          The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata.

          D Boyle, James Spies, Sheila M Gonzalves … (2002)
          To create and validate a questionnaire for assessing symptom severity and symptom impact on health-related quality of life for women with leiomyomata. The questionnaire was derived from focus groups of women with leiomyomata. Content validity was established through cognitive debriefings of women with leiomyomata and review by expert clinicians. Patients for the validation study were recruited from five gynecologists' offices, an interventional radiology department, and a University campus. Instruments used for validation were the Short Form-36, Menorrhagia Questionnaire, the Revicki-Wu Sexual Function Scale, and a physician and a patient assessment of severity. Item and exploratory factor analysis were performed to assess the subscale structure of the questionnaire. Psychometric evaluation was conducted to assess reliability and validity. Test-retest was performed on a random subset of the sample within 2 weeks of the initial visit. A total of 110 patients with confirmed leiomyomata and 29 normal subjects participated in the validation. The final questionnaire consists of eight symptom questions and 29 health-related quality of life questions with six subscales. Subscale Cronbach's alpha ranged from 0.83 to 0.95, with the overall health-related quality of life score alpha = 0.97. The Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire subscales discriminated not only from normal controls but also among leiomyomata patients with varying degrees of symptom severity. Test-retest reliability was good with intraclass correlation coefficients of 0.76-0.93. The UFS-QOL appears to be a useful new tool for detecting differences in symptom severity and health-related quality of life among patients with uterine leiomyomata. Additional study is underway to determine the responsiveness of the UFS-QOL to therapies for leiomyomata.
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            Laparoscopic radiofrequency thermal ablation: a new approach to symptomatic uterine myomas.

            Massimo Franchi, G Bellini, Stefano Scarperi … (2005)
            The purpose of this study was to evaluate the feasibility and efficacy of laparoscopic radiofrequency ablation of uterine fibroids. Eighteen women with symptomatic intramural uterine myomas underwent radiofrequency ablation under laparoscopic guidance. Postoperative sonographic evaluations of the fibroids size were scheduled at 1, 3, 6 ,9, and 12 months. The impact of myoma-related symptoms on quality of life (QOL) was assessed using a validated questionnaire. The median number of myomas treated per patient was 1 (1-3). The median baseline volume of the dominant myoma was 67.2 cm 3 (14.8-332.8). No intraoperative or postoperative complications occurred. The median reductions in myomas volume were 41.5%, 59%, and 77% at 1, 3, and 6-months, follow-up evaluation, respectively. No further change in fibroid size was observed at 9 months and 1 year. A significant improvement in the symptoms score and QOL score was observed at 3 and 6 months, follow-up. In this pilot study, laparoscopic radiofrequency ablation successfully reduced fibroid symptoms and fibroid volume in short-term follow-up. Additional studies are needed before its efficacy and safety can be confirmed.
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              Outpatient procedure for the treatment and relief of symptomatic uterine myomas.

              Gordon J. Berman, William Banks, Richard Guido … (2013)
              To estimate the safety and efficacy of laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of uterine myomas in symptomatic women. A cohort of 135 premenopausal symptomatic women with uterine myomas, uteri 14 weeks of gestation-sized or less with no single myoma exceeding 7 cm, and objectively confirmed heavy menstrual bleeding participated in this prospective, international trial of outpatient laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation. Bleeding outcomes were measured by alkaline hematin analysis at baseline and again at 3, 6, and 12 months posttreatment. Validated quality-of-life and patient satisfaction scales and objective measurements of uterine and myoma volume were conducted at 3, 6, and 12 months. The mean baseline menstrual blood loss of women in the full analysis set (n=127) was 272.7±82.3 mL. At 3-, 6-, and 12-month follow-ups, mean alkaline hematin and associated menstrual blood loss decreased from baseline levels by 31.8%, 40.7%, and 38.3%, respectively (P<.001, paired t test). Symptom severity decreased from a baseline mean transformed score of 61.1 to 26.6 at 12 months postprocedure (P<.001, paired t test). Health-related quality of life improved from a mean transformed score of 37.3 at baseline to 79.5 at 12 months (P<.001, paired t test). At 12 months postprocedure, total mean myoma volume decreased from baseline by 45.1% (measured by magnetic resonance imaging). There was one serious adverse event (one of 135 [0.7%]) requiring readmission 5 weeks postprocedure and one surgical reintervention for persistent bleeding. Ninety-four percent of the women reported satisfaction with the treatment. Radiofrequency volumetric thermal ablation of myomas is well tolerated and results in rapid recovery, high patient satisfaction, improved quality of life, and effective symptom relief. : ClinicalTrials.gov, www.clinicaltrials.gov, NCT00874029. II.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Laparoendosc Adv Surg Tech A
                Journal ID (iso-abbrev): J Laparoendosc Adv Surg Tech A
                Journal ID (publisher-id): lap
                Title: Journal of Laparoendoscopic & Advanced Surgical Techniques. Part A
                Publisher: Mary Ann Liebert, Inc., publishers (140 Huguenot Street, 3rd FloorNew Rochelle, NY 10801USA )
                ISSN (Print): 1092-6429
                ISSN (Electronic): 1557-9034
                Publication date (Print): 01 December 2019
                Publication date (Electronic): 08 November 2019
                Publication date PMC-release: 08 November 2019
                Volume: 29
                Issue: 12
                Pages: 1507-1517
                Affiliations
                [ 1 ]Department of Obstetrics and Gynecology, Women's Health Institute, Center for Menstrual Disoders, Cleveland Clinic, Cleveland, Ohio.
                [ 2 ]Department of Obstetrics and Gynecology, University of Louisville Hospital, Louisville, Kentucky.
                [ 3 ]Miller Scientific Consulting, Inc., Asheville, North Carolina.
                Author notes
                [*]Address correspondence to: Larry E. Miller, PhD, Miller Scientific Consulting, Inc., 1854 Hendersonville Road, #231, Asheville, NC 28803 larry@ 123456millerscientific.com
                Article
                Publisher ID: 10.1089/lap.2019.0550
                DOI: 10.1089/lap.2019.0550
                PMC ID: 7387230
                PubMed ID: 31702440
                SO-VID: 1b16151f-12b6-4109-bb71-89294d644fd3
                Copyright © © Linda D. Bradley et al. 2020; Published by Mary Ann Liebert, Inc.
                License:

                This Open Access article is distributed under the terms of the Creative Commons License ( http://creativecommons.org/licenses/by/4.0), , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Page count
                Figures: 7, Tables: 3, References: 46, Pages: 11
                Categories
                Subject: Full Reports

                Keywords: laparoscopic,leiomyoma,myoma,radiofrequency,transcervical,transvaginal
                Data availability:
                Keywords: laparoscopic, leiomyoma, myoma, radiofrequency, transcervical, transvaginal

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