Fertility and sterility · 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.
Сравнительное исследованиеСтатьяРандомизированное исследованиеПоддержка NIH: внешняя программаНазвание и аннотация: Перевод пока не подготовлен
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Bouwsma Esther V A, Hesley Gina K, Woodrum David A, Weaver Amy L, Leppert Phyllis C, Peterson Lisa G, Stewart Elizabeth A
Аннотация
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.
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.