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

Guido, RS and Macer, JA and Abbott, K and Falls, JL and Tilley, IB and Chudnoff, SG (2013) Radiofrequency volumetric thermal ablation of fibroids: A prospective, clinical analysis of two years' outcome from the Halt trial. Health and Quality of Life Outcomes, 11 (1). 1 - 8.

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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. © 2013 Guido et al.; licensee BioMed Central Ltd.


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Details

Item Type: Article
Status: Published
Creators/Authors:
CreatorsEmailPitt UsernameORCID
Guido, RSrsg1@pitt.eduRSG1
Macer, JA
Abbott, K
Falls, JL
Tilley, IB
Chudnoff, SG
Centers: Other Centers, Institutes, or Units > Magee-Women's Research Institute
Date: 13 August 2013
Date Type: Publication
Journal or Publication Title: Health and Quality of Life Outcomes
Volume: 11
Number: 1
Page Range: 1 - 8
DOI or Unique Handle: 10.1186/1477-7525-11-139
Schools and Programs: School of Medicine > Obstetrics, Gynecology, and Reproductive Sciences
Refereed: Yes
Date Deposited: 02 Dec 2016 14:58
Last Modified: 23 Jun 2018 11:56
URI: http://d-scholarship.pitt.edu/id/eprint/29696

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