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.
RCT Entities:
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.
Authors: James H Segars; Estella C Parrott; Joan D Nagel; Xiaoxiao Catherine Guo; Xiaohua Gao; Linda S Birnbaum; Vivian W Pinn; Darlene Dixon Journal: Hum Reprod Update Date: 2014-01-08 Impact factor: 15.610
Authors: Emily P Barnard; Ahmed M AbdElmagied; Lisa E Vaughan; Amy L Weaver; Shannon K Laughlin-Tommaso; Gina K Hesley; David A Woodrum; Vanessa L Jacoby; Maureen P Kohi; Thomas M Price; Angel Nieves; Michael J Miller; Bijan J Borah; Krzysztof R Gorny; Phyllis C Leppert; Lisa G Peterson; Elizabeth A Stewart Journal: Am J Obstet Gynecol Date: 2017-01-05 Impact factor: 8.661
Authors: Shannon Laughlin-Tommaso; Emily P Barnard; Ahmed M AbdElmagied; Lisa E Vaughan; Amy L Weaver; Gina K Hesley; David A Woodrum; Vanessa L Jacoby; Maureen P Kohi; Thomas M Price; Angel Nieves; Michael J Miller; Bijan J Borah; James P Moriarty; Krzysztof R Gorny; Phyllis C Leppert; Amanda L Severson; Maureen A Lemens; Elizabeth A Stewart Journal: Am J Obstet Gynecol Date: 2018-10-26 Impact factor: 8.661
Authors: Ahmed M AbdElmagied; Lisa E Vaughan; Amy L Weaver; Shannon K Laughlin-Tommaso; Gina K Hesley; David A Woodrum; Vanessa L Jacoby; Maureen P Kohi; Thomas M Price; Angel Nieves; Michael J Miller; Bijan J Borah; Krzysztof R Gorny; Phyllis C Leppert; Maureen A Lemens; Elizabeth A Stewart Journal: Am J Obstet Gynecol Date: 2016-04-09 Impact factor: 8.661
Authors: Shannon K Laughlin-Tommaso; Krzysztof R Gorny; Gina K Hesley; Lisa E Vaughan; David A Woodrum; Maureen A Lemens; Elizabeth A Stewart Journal: J Womens Health (Larchmt) Date: 2021-07-08 Impact factor: 2.681