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de Bruijn AM, Lohle PN, Huirne JA, et al. Uterine Artery Embolization Versus Hysterectomy in the Treatment of Symptomatic Adenomyosis: Protocol for the Randomized QUESTA Trial. JMIR Res Protoc. 2018;7(3):e47doi: 10.2196/resprot.8512.
de Bruijn, A. M., Lohle, P. N., Huirne, J. A., de Vries, J., Twisk, M., & Hehenkamp, W. J. (2018). Uterine Artery Embolization Versus Hysterectomy in the Treatment of Symptomatic Adenomyosis: Protocol for the Randomized QUESTA Trial. JMIR research protocols, 7(3), e47. https://doi.org/10.2196/resprot.8512
de Bruijn, Annefleur Machteld, et al. "Uterine Artery Embolization Versus Hysterectomy in the Treatment of Symptomatic Adenomyosis: Protocol for the Randomized QUESTA Trial." JMIR research protocols vol. 7,3 (2018): e47. doi: https://doi.org/10.2196/resprot.8512
de Bruijn AM, Lohle PN, Huirne JA, de Vries J, Twisk M, Hehenkamp WJ. Uterine Artery Embolization Versus Hysterectomy in the Treatment of Symptomatic Adenomyosis: Protocol for the Randomized QUESTA Trial. JMIR Res Protoc. 2018 Mar 01;7(3):e47. doi: 10.2196/resprot.8512. PMID: 29496654; PMCID: PMC5856934.
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JMIR Res Protoc. 2018 Mar 01;7(3):e47. doi: 10.2196/resprot.8512.

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

JMIR research protocols

Annefleur Machteld de Bruijn, Paul Nm Lohle, Judith Af Huirne, Jolanda de Vries, Moniek Twisk, Wouter Jk Hehenkamp

Affiliations

  1. Department of Gynaecology and Obstetrics, Vrije Universiteit Medical Center, Vrije Universiteit, Amsterdam, Netherlands.
  2. Amsterdam Cardiovascular Sciences, Vrije Universiteit, Amsterdam, Netherlands.
  3. Department of Radiology, Elisabeth-TweeSteden Ziekenhuis, Tilburg, Netherlands.
  4. Department of Medical and Clinical Psychology, Tilburg University, Tilburg, Netherlands.
  5. Department of Medical and Clinical Psychology, Elisabeth-TweeSteden Ziekenhuis, Tilburg, Netherlands.
  6. Department of Gynecology, Medical Center Zuiderzee, Lelystad, Netherlands.

PMID: 29496654 PMCID: PMC5856934 DOI: 10.2196/resprot.8512

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).

©Annefleur Machteld de Bruijn, Paul NM Lohle, Judith AF Huirne, Jolanda de Vries, Moniek Twisk, QUESTA-Trial Group, Wouter JK Hehenkamp. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 01.03.2018.

Keywords: adenomyosis; hysterectomy; quality of life; randomized trial; uterine artery embolization

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