Chen Innie, Berman Jay M, Balk Ethan M, Saldanha Ian J, Kowalczewski Emilie, Yi Johnny, Zanotti Salena, Al Hilli Mariam, Kho Kimberly A
Department of Obstetrics and Gynecology, The Ottawa Hospital Research Institute, University of Ottawa (Drs. Chen and Kowalczewski), Ottawa, ON, Canada.
Department of Obstetrics & Gynecology, Wayne State University School of Medicine (Dr. Berman), Detroit, Michigan.
J Minim Invasive Gynecol. 2025 Jan;32(1):74-91. doi: 10.1016/j.jmig.2024.09.011. Epub 2024 Sep 12.
To systematically review clinical and patient-reported outcomes after radiofrequency ablation (RFA) for the treatment of uterine fibroids.
We searched Medline, EMBASE, Cochrane Registry of Controlled Trials (CENTRAL) on September 8, 2023, and requested additional data from industry sources. We included published, peer-reviewed studies of patient-centered outcomes of RFA when used for symptomatic fibroids. Abstracts and potentially relevant full-text articles were screened and data were extracted regarding study characteristics, arms, outcomes, and results, together with risk of bias assessment.
We included 30 studies published in 49 articles (3 randomized controlled trials, 1 nonrandomized comparative study, and 26 single-group studies, as well as 4 publications from the TRUST Study) with variable risks of bias.
TABULATION, INTEGRATION, AND RESULTS: The study populations were demographically diverse and clinically heterogeneous. Across studies, RFA treatment was associated with fibroid volume reduction of 46.0% (95% confidence interval [CI] 52.1, 40.0; 11 studies) at 3 months and 65.4% (95% CI 74.7, 56.1; 10 studies) at 12 months. All studies reported a decrease in proportion of patients experiencing abnormal, heavy, or prolonged menstrual bleeding, with the most substantial improvement within the first 3 months. Meta-analyses of health-related quality of life scores demonstrated significant improvements in scores from baseline for Uterine Fibroid Symptoms and Quality of Life (53.4, 95% CI 48.2, 58.5; 19 studies), EuroQol-5 dimension (71.6, 95% CI 65.0, 78.1; 4 studies), and Symptom Severity Score (52.2, 95% CI 46.4, 58.1; 17 studies), with a peak at 6 months on the Uterine Fibroid Symptoms and Quality of Life scale (88.0, 95% CI 83.0, 92.9; 11 studies), a peak at 24 months on the EuroQol-5 dimension scale (88.3, 95% CI 86.0, 90.6; 2 studies), and a trough at 12 months for Symptom Severity Score (12.8, 95% CI 7.0, 18.6; 11 studies). Studies mostly demonstrated return to work and normal activities within 2 weeks. Reported unplanned hospitalizations were infrequent, and durations of hospital stay were generally short. Postprocedure complications were inconsistently reported but assessed overall to be infrequent. Long-term need for medical and surgical re-intervention varied. Post-RFA hysterectomy rates ranged from 2/205 (1.0%) to 15/62 (24.1%) with variable follow-up periods ranging from 45 days to 74 months. Most studies did not include patients who desired to maintain fertility; thus, reproductive data are insufficient for interpretation.
There is a paucity of comparative studies, and the small number of RCTs are limited by lack of blinding. Few studies had the long-term follow-up time required to draw definitive conclusions regarding the durability of symptom relief. However, despite these limitations, there is overall agreement on several important clinical measures following RFA, such as decreased fibroid volume, improved uterine bleeding, and improved quality of life. Future high-quality randomized controlled trials with standardized outcomes measures are required to better characterize the use of RFA among fibroid patients.
