Uterine Artery Embolization Versus Hysterectomy in the Treatment of Symptomatic Adenomyosis: Protocol for the Randomized QUESTA Trial

JMIR Research Protocols
Annefleur Machteld de BruijnWouter Jk Hehenkamp

Abstract

Adenomyosis is a benign uterine disease characterized by invasion of endometrium into the myometrium resulting in heavy menstrual bleeding and pain (dysmenorrhea). Hysterectomy is established as the final treatment option when conservative treatment fails. Uterine artery embolization (UAE) in patients with symptomatic adenomyosis has demonstrated to reduce symptoms and improve quality of life. However, randomized controlled trials are lacking. With this study, we aim to evaluate the impact of UAE on Health-Related Quality of Life (HRQOL) in a randomized comparison to hysterectomy in patients with symptomatic adenomyosis. This is a multicenter non-blinded randomized controlled trial comparing UAE and hysterectomy. Eligible patients are symptomatic premenopausal women without the desire to conceive and who have symptomatic magnetic resonance imaging (MRI)-confirmed pure adenomyosis or dominant adenomyosis accompanied by fibroids. After obtaining informed consent, patients will be randomly allocated to treatment in a 2:1 UAE versus hysterectomy ratio. The primary objective is HRQOL at 6 months following the assigned intervention. Secondary outcomes are technical results, pain management, clinical outcomes, HRQOL, and cost effectiv...Continue Reading

Associated Clinical Trials

References

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Jul 10, 2016·American Journal of Obstetrics and Gynecology·Annefleur M de BruijnWouter J K Hehenkamp

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Citations

Apr 30, 2020·Experimental and Therapeutic Medicine·Vasileios SouftasPanagiotis Tsikouras
Sep 11, 2019·Human Reproduction Update·Marissa J HarmsenJudith A F Huirne
Feb 15, 2021·The Australian & New Zealand Journal of Obstetrics & Gynaecology·Jolande MaEisen Liang
Jun 21, 2021·Techniques in Vascular and Interventional Radiology·Theresa M Caridi
Aug 8, 2021·Journal of Clinical Medicine·Fady I ShararaGaby N Moawad

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Methods Mentioned

BETA
hysterectomy
sedation
PCA
hysterectomies

Software Mentioned

QUESTA

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