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

Annefleur M. de Bruijn, Paul N.M. Lohle, Judith A.F. Huirne, Jolanda De Vries, Moniek Twisk, QUESTA-Trial Group, Wouter J.K. Hehenkamp
2017 · doi:10.2196/preprints.8512 · W4255167043
preprint OA: closed CC0
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⚙ AI-generated summary by claude@2026-06, 2026-06-06 ⓘ

The QUESTA trial is a randomized comparison of uterine artery embolization versus hysterectomy to evaluate health-related quality of life at six months for women with symptomatic adenomyosis.

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⚙ AI-generated deep summary by claude@2026-06, 2026-06-06 · read from full text ⓘ

This paper reports the protocol for the randomized, multicenter QUESTA trial, which compares uterine artery embolization (UAE) versus hysterectomy for symptomatic, MRI-confirmed pure or dominant adenomyosis (with or without fibroids) in premenopausal women who do not desire future conception. The non-blinded trial plans a 2:1 randomization to UAE versus hysterectomy, with the primary outcome being health-related quality of life (HRQOL) at 6 months and secondary outcomes including pain management, clinical outcomes, technical results, and cost-effectiveness over 2 years. The authors note that enrollment began in November 2015 and that, at submission, data cleaning and analyses had not yet started, limiting results to trial design rather than findings. This paper is centrally about adenomyosis — it is the protocol for a randomized controlled trial evaluating UAE versus hysterectomy for symptomatic adenomyosis and their impact on HRQOL.

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Abstract

BACKGROUND 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. OBJECTIVE 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. METHODS 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 effectiveness during 2 years of follow-up. In addition, transvaginal ultrasound (TVUS) and MRI will be performed at regular intervals after UAE. RESULTS Patient enrollment started November 2015. The follow-up period will be completed two years after inclusion of the last patient. At the time of submission of this article, data cleaning and analyses have not yet started. CONCLUSIONS This trial will provide insight for caretakers and future patients about the effect of UAE compared to the gold standard hysterectomy in the treatment of symptomatic adenomyosis and is therefore expected to improve patients’ wellbeing and quality of life. CLINICALTRIAL Netherlands Trial Register NTR5615; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5615 (Archived by WebCite at http://www.webcitation.org/6xZRyXeIF)
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Abstract

Background: 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.

Objective

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.

Methods

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 effectiveness during 2 years of follow-up. In addition, transvaginal ultrasound (TVUS) and MRI will be performed at regular intervals after UAE.

Results

Patient enrollment started November 2015. The follow-up period will be completed two years after inclusion of the last patient. At the time of submission of this article, data cleaning and analyses have not yet started.

Conclusions

This trial will provide insight for caretakers and future patients about the effect of UAE compared to the gold standard hysterectomy in the treatment of symptomatic adenomyosis and is therefore expected to improve patients’ wellbeing and quality of life. Trial Registration: Netherlands Trial Register NTR5615; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5615 (Archived by WebCite at http://www.webcitation.org/6xZRyXeIF)

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Condition tags

adenomyosisdysmenorrhea

Citation neighborhood

Papers in the corpus that this work cites (lower rings, blue) and that cite this one (upper rings, green). Dot size scales with the paper's in-corpus citation count — bigger dot = more influential within the endo/adeno field. Click a dot to open that paper. [ expand to 2 hops ] — adds papers reached through this work's immediate citers/citees. Heavier; up to 60 extra dots.

References (22)

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