Uterine artery embolization or myomectomy for women with uterine fibroids: Four-year follow-up of a randomised controlled trial

Objective: To examine the quality of life experienced by women with symptomatic uterine fibroids who had been treated with UAE in comparison to myomectomy. We report the four-year follow-up of the FEMME randomised trial. Two-year follow-up data has been previously reported. Study Design: Premenopaus...

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Autores principales:	Jane Daniels, Lee J. Middleton, Versha Cheed, William McKinnon, Fusun Sirkeci, Isaac Manyonda, Anna-Maria Belli, Mary Ann Lumsden, Jonathan Moss, Olivia Wu, Klim McPherson, on behalf of the FEMME Trial Collaborative Group
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2022
Materias:	Adult Female Human Myomectomy Pregnancy rate Quality of life Gynecology and obstetrics RG1-991
Acceso en línea:	https://doaj.org/article/1db5aefd88d14bbb9976997adbe7011e
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spelling	oai:doaj.org-article:1db5aefd88d14bbb9976997adbe7011e2021-11-28T04:37:57ZUterine artery embolization or myomectomy for women with uterine fibroids: Four-year follow-up of a randomised controlled trial2590-161310.1016/j.eurox.2021.100139https://doaj.org/article/1db5aefd88d14bbb9976997adbe7011e2022-01-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2590161321000193https://doaj.org/toc/2590-1613Objective: To examine the quality of life experienced by women with symptomatic uterine fibroids who had been treated with UAE in comparison to myomectomy. We report the four-year follow-up of the FEMME randomised trial. Two-year follow-up data has been previously reported. Study Design: Premenopausal women who had symptomatic uterine fibroids amenable to myomectomy or uterine artery embolization were recruited from 29 UK hospitals. Women were excluded if they had significant adenomyosis, any malignancy, pelvic inflammatory disease or had had a previous open myomectomy or uterine artery embolization.Participants were randomised to myomectomy or embolization in a 1:1 ratio using a minimisation algorithm. Myomectomy could be open abdominal, laparoscopic or hysteroscopic, according to clinician preference. Embolization of the uterine arteries was performed according to local practice, under fluoroscopic guidance.The primary outcome measure was the Uterine Fibroid Symptom Quality of Life questionnaire, adjusted for baseline score and reported here at four years post-randomisation. Subsequent procedures for fibroids, pregnancy and outcome were amongst secondary outcomes.Trial registration ISRCTN70772394 https://doi.org/10.1186/ISRCTN70772394 Results: 254 women were randomized, 127 to myomectomy (105 underwent myomectomy) and 127 to uterine artery embolization (98 underwent embolization). At four years, 67 (53%) and 81 (64%) completed UFS-QoL quality of life scores. Mean difference in the UFS-QoL at 4 years was 5.0 points (95% CI −1.4 to 11.5; p = 0.13) in favour of myomectomy. There were 15 pregnancies in the UAE group and 7 in the myomectomy group, with a cumulative pregnancy rate to four years of 15% and 6% respectively (hazard ratio: 0.48; 95% CI 0.18–1.28). The cumulative repeat procedure rate to four years was 24% in the UAE group and 13% in the myomectomy group (hazard ratio: 0.53; 95% CI 0.27–1.05). Conclusions: Myomectomy resulted in greater improvement in quality of life compared with uterine artery embolization, although by four years, this difference was not statistically significant. Missing data may limit the generalisability of this result. The numbers of women becoming pregnant were too small draw a conclusion on the effect of the procedures on fertility.Jane DanielsLee J. MiddletonVersha CheedWilliam McKinnonFusun SirkeciIsaac ManyondaAnna-Maria BelliMary Ann LumsdenJonathan MossOlivia WuKlim McPherson on behalf of the FEMME Trial Collaborative GroupElsevierarticleAdultFemaleHumanMyomectomyPregnancy rateQuality of lifeGynecology and obstetricsRG1-991ENEuropean Journal of Obstetrics & Gynecology and Reproductive Biology: X, Vol 13, Iss , Pp 100139- (2022)
institution	DOAJ
collection	DOAJ
language	EN
topic	Adult Female Human Myomectomy Pregnancy rate Quality of life Gynecology and obstetrics RG1-991
spellingShingle	Adult Female Human Myomectomy Pregnancy rate Quality of life Gynecology and obstetrics RG1-991 Jane Daniels Lee J. Middleton Versha Cheed William McKinnon Fusun Sirkeci Isaac Manyonda Anna-Maria Belli Mary Ann Lumsden Jonathan Moss Olivia Wu Klim McPherson on behalf of the FEMME Trial Collaborative Group Uterine artery embolization or myomectomy for women with uterine fibroids: Four-year follow-up of a randomised controlled trial
description	Objective: To examine the quality of life experienced by women with symptomatic uterine fibroids who had been treated with UAE in comparison to myomectomy. We report the four-year follow-up of the FEMME randomised trial. Two-year follow-up data has been previously reported. Study Design: Premenopausal women who had symptomatic uterine fibroids amenable to myomectomy or uterine artery embolization were recruited from 29 UK hospitals. Women were excluded if they had significant adenomyosis, any malignancy, pelvic inflammatory disease or had had a previous open myomectomy or uterine artery embolization.Participants were randomised to myomectomy or embolization in a 1:1 ratio using a minimisation algorithm. Myomectomy could be open abdominal, laparoscopic or hysteroscopic, according to clinician preference. Embolization of the uterine arteries was performed according to local practice, under fluoroscopic guidance.The primary outcome measure was the Uterine Fibroid Symptom Quality of Life questionnaire, adjusted for baseline score and reported here at four years post-randomisation. Subsequent procedures for fibroids, pregnancy and outcome were amongst secondary outcomes.Trial registration ISRCTN70772394 https://doi.org/10.1186/ISRCTN70772394 Results: 254 women were randomized, 127 to myomectomy (105 underwent myomectomy) and 127 to uterine artery embolization (98 underwent embolization). At four years, 67 (53%) and 81 (64%) completed UFS-QoL quality of life scores. Mean difference in the UFS-QoL at 4 years was 5.0 points (95% CI −1.4 to 11.5; p = 0.13) in favour of myomectomy. There were 15 pregnancies in the UAE group and 7 in the myomectomy group, with a cumulative pregnancy rate to four years of 15% and 6% respectively (hazard ratio: 0.48; 95% CI 0.18–1.28). The cumulative repeat procedure rate to four years was 24% in the UAE group and 13% in the myomectomy group (hazard ratio: 0.53; 95% CI 0.27–1.05). Conclusions: Myomectomy resulted in greater improvement in quality of life compared with uterine artery embolization, although by four years, this difference was not statistically significant. Missing data may limit the generalisability of this result. The numbers of women becoming pregnant were too small draw a conclusion on the effect of the procedures on fertility.
format	article
author	Jane Daniels Lee J. Middleton Versha Cheed William McKinnon Fusun Sirkeci Isaac Manyonda Anna-Maria Belli Mary Ann Lumsden Jonathan Moss Olivia Wu Klim McPherson on behalf of the FEMME Trial Collaborative Group
author_facet	Jane Daniels Lee J. Middleton Versha Cheed William McKinnon Fusun Sirkeci Isaac Manyonda Anna-Maria Belli Mary Ann Lumsden Jonathan Moss Olivia Wu Klim McPherson on behalf of the FEMME Trial Collaborative Group
author_sort	Jane Daniels
title	Uterine artery embolization or myomectomy for women with uterine fibroids: Four-year follow-up of a randomised controlled trial
title_short	Uterine artery embolization or myomectomy for women with uterine fibroids: Four-year follow-up of a randomised controlled trial
title_full	Uterine artery embolization or myomectomy for women with uterine fibroids: Four-year follow-up of a randomised controlled trial
title_fullStr	Uterine artery embolization or myomectomy for women with uterine fibroids: Four-year follow-up of a randomised controlled trial
title_full_unstemmed	Uterine artery embolization or myomectomy for women with uterine fibroids: Four-year follow-up of a randomised controlled trial
title_sort	uterine artery embolization or myomectomy for women with uterine fibroids: four-year follow-up of a randomised controlled trial
publisher	Elsevier
publishDate	2022
url	https://doaj.org/article/1db5aefd88d14bbb9976997adbe7011e
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Uterine artery embolization or myomectomy for women with uterine fibroids: Four-year follow-up of a randomised controlled trial

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