Comparing focused ultrasound and uterine artery embolization for uterine fibroids—rationale and design of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) trial
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) Par...
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| Veröffentlicht in: | Fertility and sterility 2011-09, Vol.96 (3), p.704-710 |
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| creator | Bouwsma, Esther V.A., M.D Hesley, Gina K., M.D Woodrum, David A., M.D., Ph.D Weaver, Amy L., M.S Leppert, Phyllis C., M.D., Ph.D Peterson, Lisa G., R.N., M.A.N Stewart, Elizabeth A., M.D |
| description | 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. |
| doi_str_mv | 10.1016/j.fertnstert.2011.06.062 |
| format | Article |
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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.</description><identifier>ISSN: 0015-0282</identifier><identifier>EISSN: 1556-5653</identifier><identifier>DOI: 10.1016/j.fertnstert.2011.06.062</identifier><identifier>PMID: 21794858</identifier><identifier>CODEN: FESTAS</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Biological and medical sciences ; economic analysis ; economic impact ; Embolization, Therapeutic - methods ; Evidence-Based Medicine - methods ; Female ; Female genital diseases ; focused ultrasound ; Gynecology. Andrology. Obstetrics ; health care workers ; Humans ; Internal Medicine ; Leiomyoma - diagnostic imaging ; Leiomyoma - pathology ; Leiomyoma - therapy ; Leiomyomas ; Magnetic Resonance Imaging ; Medical sciences ; MRgFUS ; Obstetrics and Gynecology ; patients ; premenopause ; Quality of Life ; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) ; randomized clinical trial ; randomized clinical trials ; recruitment ; Research Design ; Tumors ; ultrasonics ; Ultrasonography ; Uterine Artery - diagnostic imaging ; uterine artery embolization ; Uterine Neoplasms - diagnostic imaging ; Uterine Neoplasms - pathology ; Uterine Neoplasms - therapy ; women</subject><ispartof>Fertility and sterility, 2011-09, Vol.96 (3), p.704-710</ispartof><rights>American Society for Reproductive Medicine</rights><rights>2011 American Society for Reproductive Medicine</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.</rights><rights>2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved. 2011</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c587t-f54fff660d9f8689a2b7f6e9a18098e1612509123f13a9e14f765b5bc95a76033</citedby><cites>FETCH-LOGICAL-c587t-f54fff660d9f8689a2b7f6e9a18098e1612509123f13a9e14f765b5bc95a76033</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0015028211010399$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24533191$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21794858$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bouwsma, Esther V.A., M.D</creatorcontrib><creatorcontrib>Hesley, Gina K., M.D</creatorcontrib><creatorcontrib>Woodrum, David A., M.D., Ph.D</creatorcontrib><creatorcontrib>Weaver, Amy L., M.S</creatorcontrib><creatorcontrib>Leppert, Phyllis C., M.D., Ph.D</creatorcontrib><creatorcontrib>Peterson, Lisa G., R.N., M.A.N</creatorcontrib><creatorcontrib>Stewart, Elizabeth A., M.D</creatorcontrib><title>Comparing focused ultrasound and uterine artery embolization for uterine fibroids—rationale and design of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) trial</title><title>Fertility and sterility</title><addtitle>Fertil Steril</addtitle><description>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. 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Obstetrics</subject><subject>health care workers</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Leiomyoma - diagnostic imaging</subject><subject>Leiomyoma - pathology</subject><subject>Leiomyoma - therapy</subject><subject>Leiomyomas</subject><subject>Magnetic Resonance Imaging</subject><subject>Medical sciences</subject><subject>MRgFUS</subject><subject>Obstetrics and Gynecology</subject><subject>patients</subject><subject>premenopause</subject><subject>Quality of Life</subject><subject>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. 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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.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>21794858</pmid><doi>10.1016/j.fertnstert.2011.06.062</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Fertility and sterility, 2011-09, Vol.96 (3), p.704-710 |
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| subjects | Biological and medical sciences economic analysis economic impact Embolization, Therapeutic - methods Evidence-Based Medicine - methods Female Female genital diseases focused ultrasound Gynecology. Andrology. Obstetrics health care workers Humans Internal Medicine Leiomyoma - diagnostic imaging Leiomyoma - pathology Leiomyoma - therapy Leiomyomas Magnetic Resonance Imaging Medical sciences MRgFUS Obstetrics and Gynecology patients premenopause Quality of Life Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) randomized clinical trial randomized clinical trials recruitment Research Design Tumors ultrasonics Ultrasonography Uterine Artery - diagnostic imaging uterine artery embolization Uterine Neoplasms - diagnostic imaging Uterine Neoplasms - pathology Uterine Neoplasms - therapy women |
| title | Comparing focused ultrasound and uterine artery embolization for uterine fibroids—rationale and design of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) trial |
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