TY - JOUR
T1 - A multi-centre, randomized, non-inferiority trial to compare ulipristal with standard surgical treatment in women with symptomatic uterine fibroids
T2 - Protocol of the MYOMEX-2 trial
AU - Middelkoop, Mei An
AU - Huirne, Judith A.F.
AU - van der Weide, Marijke C.Jansen
AU - Bosmans, Judith E.
AU - Hehenkamp, Wouter J.K.
N1 - Funding Information: This trial and this work is investigator-driven and was supported by ZonMw grant 843002804 . ZonMw is a Dutch Governmental Organisation for Health Research and Development. This funding source has no interest in the outcome of the study and had no role in the design of this study nor will it participate in the execution, analyses, interpretation of the data, or decision to submit results. Funding Information: This trial and this work is investigator-driven and was supported by ZonMw grant 843002804. ZonMw is a Dutch Governmental Organisation for Health Research and Development. This funding source has no interest in the outcome of the study and had no role in the design of this study nor will it participate in the execution, analyses, interpretation of the data, or decision to submit results. Publisher Copyright: © 2020 The Author(s)
PY - 2021/1/1
Y1 - 2021/1/1
N2 - Objectives: Fibroids are the most common benign tumours found in the uterus and can cause various symptoms. In 20–50 % of the women, an intervention is required. When conservative options fail, invasive options such as hysterectomy, uterine artery embolization or myomectomy are eligible options. Ulipristal acetate (UPA) was launched as the sole available long term pharmaceutical treatment, with the potential to avoid surgery. It is suggested that UPA improves quality of life, reduces symptoms and fibroid volumes. However, UPA is an expensive medicine, is possibly associated with liver injury and has never been directly compared to surgical treatment. The aim of this trial is to compare UPA to surgical treatment on both effectiveness and cost-effectiveness. Primary outcome is the reduction in symptom severity scores (part of the Uterine Fibroid Symptom and Quality of Life questionnaire) at 24 months of follow-up compared to baseline. Secondary outcomes include quality of life, societal costs, societal participation, liver function variation, patient satisfaction and preference. Outcomes will be analysed according to intention-to-treat principle. Study Design: The MYOMEX-2 trial is an open-label, multicentre, non-inferiority randomized controlled trial. Patients are pre-menopausal women with symptomatic fibroids eligible for surgical treatment (hysterectomy, myomectomy or UAE). Fibroid symptoms may comprise (but are not limited to) heavy menstrual bleeding, bulk symptoms or pain. Patients are randomised 2:1 in a parallel group design between two treatment arms: 119 patients in the UPA group and 60 patients in the surgery group. Follow up comprises of online questionnaires, outpatient visits and phone appointments on several follow up moments, up to 24 months after surgery or start UPA. Registration details: MYOMEX-2 trial; protocol version 4, date 22−02-2019; NTR6860; NL62638.029.18. All items from the World Health Organization Trial Registration Data Set are provided in the online supplementary file (Appendix-B).
AB - Objectives: Fibroids are the most common benign tumours found in the uterus and can cause various symptoms. In 20–50 % of the women, an intervention is required. When conservative options fail, invasive options such as hysterectomy, uterine artery embolization or myomectomy are eligible options. Ulipristal acetate (UPA) was launched as the sole available long term pharmaceutical treatment, with the potential to avoid surgery. It is suggested that UPA improves quality of life, reduces symptoms and fibroid volumes. However, UPA is an expensive medicine, is possibly associated with liver injury and has never been directly compared to surgical treatment. The aim of this trial is to compare UPA to surgical treatment on both effectiveness and cost-effectiveness. Primary outcome is the reduction in symptom severity scores (part of the Uterine Fibroid Symptom and Quality of Life questionnaire) at 24 months of follow-up compared to baseline. Secondary outcomes include quality of life, societal costs, societal participation, liver function variation, patient satisfaction and preference. Outcomes will be analysed according to intention-to-treat principle. Study Design: The MYOMEX-2 trial is an open-label, multicentre, non-inferiority randomized controlled trial. Patients are pre-menopausal women with symptomatic fibroids eligible for surgical treatment (hysterectomy, myomectomy or UAE). Fibroid symptoms may comprise (but are not limited to) heavy menstrual bleeding, bulk symptoms or pain. Patients are randomised 2:1 in a parallel group design between two treatment arms: 119 patients in the UPA group and 60 patients in the surgery group. Follow up comprises of online questionnaires, outpatient visits and phone appointments on several follow up moments, up to 24 months after surgery or start UPA. Registration details: MYOMEX-2 trial; protocol version 4, date 22−02-2019; NTR6860; NL62638.029.18. All items from the World Health Organization Trial Registration Data Set are provided in the online supplementary file (Appendix-B).
KW - Hysterectomy
KW - Leiomyoma
KW - Quality of life
KW - Randomized controlled trial
KW - Surgery
KW - Ulipristal acetate
UR - http://www.scopus.com/inward/record.url?scp=85096341334&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.ejogrb.2020.10.058
DO - https://doi.org/10.1016/j.ejogrb.2020.10.058
M3 - Article
C2 - 33171419
SN - 0301-2115
VL - 256
SP - 63
EP - 69
JO - European Journal of Obstetrics and Gynecology and Reproductive Biology
JF - European Journal of Obstetrics and Gynecology and Reproductive Biology
ER -