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

Richard S. Guido, James A. Macer, Karen Abbott, Janice Lynn Falls, Ian B. Tilley, Scott G. Chudnoff

Research output: Contribution to journalArticle

18 Citations (Scopus)

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.

Original languageEnglish (US)
Article number139
Pages (from-to)1-8
Number of pages8
JournalHealth and Quality of Life Outcomes
Volume11
Issue number1
DOIs
StatePublished - Aug 13 2013

Fingerprint

Leiomyoma
Hot Temperature
Quality of Life
Myoma
Uterine Diseases
Hemorrhage
Consciousness
Outpatients
Outcome Assessment (Health Care)
Clinical Trials
Therapeutics

Keywords

  • Fibroid
  • Laparoscopic ultrasound
  • Myoma
  • Quality of life
  • Radiofrequency ablation
  • Ultrasound

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

Cite this

Radiofrequency volumetric thermal ablation of fibroids : A prospective, clinical analysis of two years' outcome from the Halt trial. / Guido, Richard S.; Macer, James A.; Abbott, Karen; Falls, Janice Lynn; Tilley, Ian B.; Chudnoff, Scott G.

In: Health and Quality of Life Outcomes, Vol. 11, No. 1, 139, 13.08.2013, p. 1-8.

Research output: Contribution to journalArticle

Guido, Richard S. ; Macer, James A. ; Abbott, Karen ; Falls, Janice Lynn ; Tilley, Ian B. ; Chudnoff, Scott G. / Radiofrequency volumetric thermal ablation of fibroids : A prospective, clinical analysis of two years' outcome from the Halt trial. In: Health and Quality of Life Outcomes. 2013 ; Vol. 11, No. 1. pp. 1-8.
@article{4a4abc32d3b947629a20ef4dd4c5d752,
title = "Radiofrequency volumetric thermal ablation of fibroids: A prospective, clinical analysis of two years' outcome from the Halt trial",
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 = "Fibroid, Laparoscopic ultrasound, Myoma, Quality of life, Radiofrequency ablation, Ultrasound",
author = "Guido, {Richard S.} and Macer, {James A.} and Karen Abbott and Falls, {Janice Lynn} and Tilley, {Ian B.} and Chudnoff, {Scott G.}",
year = "2013",
month = "8",
day = "13",
doi = "10.1186/1477-7525-11-139",
language = "English (US)",
volume = "11",
pages = "1--8",
journal = "Health and Quality of Life Outcomes",
issn = "1477-7525",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - Radiofrequency volumetric thermal ablation of fibroids

T2 - A prospective, clinical analysis of two years' outcome from the Halt trial

AU - Guido, Richard S.

AU - Macer, James A.

AU - Abbott, Karen

AU - Falls, Janice Lynn

AU - Tilley, Ian B.

AU - Chudnoff, Scott G.

PY - 2013/8/13

Y1 - 2013/8/13

N2 - 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.

AB - 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.

KW - Fibroid

KW - Laparoscopic ultrasound

KW - Myoma

KW - Quality of life

KW - Radiofrequency ablation

KW - Ultrasound

UR - http://www.scopus.com/inward/record.url?scp=84882656926&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84882656926&partnerID=8YFLogxK

U2 - 10.1186/1477-7525-11-139

DO - 10.1186/1477-7525-11-139

M3 - Article

C2 - 23941588

AN - SCOPUS:84882656926

VL - 11

SP - 1

EP - 8

JO - Health and Quality of Life Outcomes

JF - Health and Quality of Life Outcomes

SN - 1477-7525

IS - 1

M1 - 139

ER -