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Open Access Research

Radiofrequency volumetric thermal ablation of fibroids: a prospective, clinical analysis of two years’ outcome from the Halt trial

Richard S Guido1*, James A Macer2, Karen Abbott3, Janice L Falls4, Ian B Tilley5 and Scott G Chudnoff4

Author Affiliations

1 Department of Obstetrics, Gynecology and Reproductive Sciences, Division of Gynecologic Specialties, University of Pittsburgh Medical Center, Magee-Women’s Research Institute, Pittsburgh, PA, USA

2 Department of Obstetrics and Gynecology, Huntington Hospital, Pasadena, CA, USA

3 Athena Gynecology Medical Group, Reno, NV, USA

4 Department of Obstetrics and Gynecology and Women’s Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA

5 Department of Clinical Obstetrics and Gynecology, Los Angeles County and University of Southern California Medical Center, Los Angeles, USA

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Health and Quality of Life Outcomes 2013, 11:139  doi:10.1186/1477-7525-11-139

Published: 13 August 2013

Abstract

Background

Although most myomas are asymptomatic, quality of life is compromised for many women with uterine fibroid disease. Twelve-month outcomes from the Halt Trial have been reported in the literature. Here we analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) of symptomatic uterine fibroids at two years of follow up.

Methods

Prospective, multicenter, outpatient interventional clinical trial of fibroid treatment by RFVTA in 124 premenopausal women (mean age, 42.4 ± 4.4 years) with symptomatic uterine fibroids and objectively confirmed heavy menstrual bleeding (≥160 to ≤500 mL).

Outcome measures included: subject responses to validated questionnaires, treatment-emergent adverse events, and surgical re-intervention for fibroids at 24 months postprocedure. Continuous and categorical variables were summarized using descriptive statistics and means and percentages. Comparisons between visits were based on t-tests using repeated measures models. P-values < 0.05, adjusted for multiplicity, were statistically significant.

Results

One hundred twelve subjects were followed through 24 months. Change in symptom severity from baseline was –35.7 (95% CI, –40.1 to –31.4; p<.001). Change in health-related quality of life (HRQL) was 40.9 (95% CI, 36.2 to 45.6; p < .001). HRQL subscores also improved significantly from baseline to 24 months in all categories (concern, activities, energy/mood, control, self-consciousness, and sexual function) [p<.001]. Six patients underwent surgical re-intervention for fibroid-related bleeding between 12 and 24 months providing a re-intervention rate of 4.8% (6/124).

Conclusion

Radiofrequency volumetric thermal ablation of myomas significantly reduces symptom severity and improves quality of life with low surgical re-intervention through 24 months of follow up.

Trial registration

ClinicalTrials.gov: NCT00874029

Keywords:
Radiofrequency ablation; Ultrasound; Laparoscopic ultrasound; Fibroid; Myoma; Quality of life