Comparing focused ultrasound and uterine artery embolization for uterine fibroids - Rationale and design of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) trial

Esther V.A. Bouwsma; Gina K. Hesley; David A. Woodrum; Amy L. Weaver; Phyllis C. Leppert; Lisa G. Peterson; Elizabeth A. Stewart

doi:10.1016/j.fertnstert.2011.06.062

Comparing focused ultrasound and uterine artery embolization for uterine fibroids - Rationale and design of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) trial

Esther V.A. Bouwsma, Gina K. Hesley, David A. Woodrum, Amy L. Weaver, Phyllis C. Leppert, Lisa G. Peterson, Elizabeth A. Stewart

Research output: Contribution to journal › Article › peer-review

35 Scopus citations

Abstract

Objective: To present the rationale, design, and methodology of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) study. Design: Randomized clinical trial. Setting: Two academic medical centers. Patient(s): Premenopausal women with symptomatic uterine fibroids. Intervention(s): Participants are randomized to two U.S. Food and Drug Administration-approved minimally invasive treatments for uterine leiomyomas: uterine artery embolization and magnetic resonance-guided focused ultrasound. Main Outcome Measure(s): The primary endpoint is defined as the need for an additional intervention for fibroid symptoms following treatment. Secondary outcomes consist of group differences in symptom alleviation, recovery trajectory, health-related quality of life, impairment of ovarian reserve, treatment complications, and the economic impact of these issues. Result(s): The trial is currently in the phase of active recruitment. Conclusion(s): This randomized clinical trial will provide important evidence-based information for patients and health care providers regarding optimal minimally invasive treatment approach for women with symptomatic uterine leiomyomas. Clinical Trial Registration: NCT00995878.

Original language	English (US)
Pages (from-to)	704-710
Number of pages	7
Journal	Fertility and sterility
Volume	96
Issue number	3
DOIs	https://doi.org/10.1016/j.fertnstert.2011.06.062
State	Published - Sep 2011

Keywords

Leiomyomas
MRgFUS
economic analysis
focused ultrasound
randomized clinical trial
uterine artery embolization

ASJC Scopus subject areas

Reproductive Medicine
Obstetrics and Gynecology

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10.1016/j.fertnstert.2011.06.062

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Bouwsma, E. V. A., Hesley, G. K., Woodrum, D. A., Weaver, A. L., Leppert, P. C., Peterson, L. G., & Stewart, E. A. (2011). Comparing focused ultrasound and uterine artery embolization for uterine fibroids - Rationale and design of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) trial. Fertility and sterility, 96(3), 704-710. https://doi.org/10.1016/j.fertnstert.2011.06.062

Comparing focused ultrasound and uterine artery embolization for uterine fibroids - Rationale and design of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) trial. / Bouwsma, Esther V.A.; Hesley, Gina K.; Woodrum, David A. et al.
In: Fertility and sterility, Vol. 96, No. 3, 09.2011, p. 704-710.

Research output: Contribution to journal › Article › peer-review

Bouwsma, EVA, Hesley, GK, Woodrum, DA, Weaver, AL, Leppert, PC, Peterson, LG & Stewart, EA 2011, 'Comparing focused ultrasound and uterine artery embolization for uterine fibroids - Rationale and design of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) trial', Fertility and sterility, vol. 96, no. 3, pp. 704-710. https://doi.org/10.1016/j.fertnstert.2011.06.062

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abstract = "Objective: To present the rationale, design, and methodology of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) study. Design: Randomized clinical trial. Setting: Two academic medical centers. Patient(s): Premenopausal women with symptomatic uterine fibroids. Intervention(s): Participants are randomized to two U.S. Food and Drug Administration-approved minimally invasive treatments for uterine leiomyomas: uterine artery embolization and magnetic resonance-guided focused ultrasound. Main Outcome Measure(s): The primary endpoint is defined as the need for an additional intervention for fibroid symptoms following treatment. Secondary outcomes consist of group differences in symptom alleviation, recovery trajectory, health-related quality of life, impairment of ovarian reserve, treatment complications, and the economic impact of these issues. Result(s): The trial is currently in the phase of active recruitment. Conclusion(s): This randomized clinical trial will provide important evidence-based information for patients and health care providers regarding optimal minimally invasive treatment approach for women with symptomatic uterine leiomyomas. Clinical Trial Registration: NCT00995878.",

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AU - Peterson, Lisa G.

AU - Stewart, Elizabeth A.

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N2 - Objective: To present the rationale, design, and methodology of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) study. Design: Randomized clinical trial. Setting: Two academic medical centers. Patient(s): Premenopausal women with symptomatic uterine fibroids. Intervention(s): Participants are randomized to two U.S. Food and Drug Administration-approved minimally invasive treatments for uterine leiomyomas: uterine artery embolization and magnetic resonance-guided focused ultrasound. Main Outcome Measure(s): The primary endpoint is defined as the need for an additional intervention for fibroid symptoms following treatment. Secondary outcomes consist of group differences in symptom alleviation, recovery trajectory, health-related quality of life, impairment of ovarian reserve, treatment complications, and the economic impact of these issues. Result(s): The trial is currently in the phase of active recruitment. Conclusion(s): This randomized clinical trial will provide important evidence-based information for patients and health care providers regarding optimal minimally invasive treatment approach for women with symptomatic uterine leiomyomas. Clinical Trial Registration: NCT00995878.

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Comparing focused ultrasound and uterine artery embolization for uterine fibroids - Rationale and design of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) trial

Abstract

Keywords

ASJC Scopus subject areas

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