ZEG Berlin, 10115, Berlin, Germany.
Department of Reproductive Endocrinology, University of Zurich, 8001, Zurich, Switzerland.
Sci Rep. 2021 Oct 14;11(1):20404. doi: 10.1038/s41598-021-99681-3.
Endometriosis is a chronic disease that requires a suitable, lifelong treatment. To our knowledge, the Visanne Post-approval Observational Study (VIPOS) is to date the largest real-world, non-interventional study investigating hormonal management of endometriosis. We describe women's experiences of endometriosis in the real world by considering their symptoms and the diagnostic process in their healthcare setting. Overall, 27,840 women were enrolled from six European countries via networks of gynecologists or specialized centers. Of these, 87.8% of women were diagnosed based on clinical symptoms; the greatest and lowest proportions of women were in Russia (94.1%) and Germany (61.9%), respectively. Most women (82.8%) experienced at least one of the triad of endometriosis-associated pain symptoms: pelvic pain, pain after/during sexual intercourse, and painful menstrual periods. The most frequently reported endometriosis-associated symptoms were painful periods (61.8%), heavy/irregular bleeding (50.8%), and pelvic pain (37.2%). Women reported that endometriosis impacted their mood; 55.6% reported feeling "down", depressed, or hopeless, and 53.2% reported feeling like a failure or having let down family/friends. VIPOS broadens our understanding of endometriosis based on real-world data by exploring the heterogeneity of symptoms women with endometriosis experience and the differences in diagnostic approaches between European countries.Trial registration: ClinicalTrials.gov, NCT01266421; registered 24 December 2010. Registered in the European Union electronic Register of Post-Authorisation Studies as number 1613.
子宫内膜异位症是一种需要长期治疗的慢性疾病。据我们所知，Visanne 上市后观察研究（VIPOS）是迄今为止规模最大的真实世界、非干预性研究，旨在调查子宫内膜异位症的激素管理。我们通过考虑女性在医疗保健环境中的症状和诊断过程，描述了她们在现实世界中的子宫内膜异位症体验。来自六个欧洲国家的 27840 名女性通过妇科医生或专门中心的网络被纳入该研究。其中，87.8%的女性基于临床症状被诊断；俄罗斯（94.1%）和德国（61.9%）的女性比例最高和最低。大多数女性（82.8%）经历了至少一种与子宫内膜异位症相关的三联征疼痛症状：盆腔疼痛、性交后/期间疼痛和痛经。最常报告的与子宫内膜异位症相关的症状是痛经（61.8%）、经量过多/不规则（50.8%）和盆腔疼痛（37.2%）。女性报告称子宫内膜异位症影响了她们的情绪；55.6%的女性感到“沮丧”、抑郁或绝望，53.2%的女性感到自己是失败者或让家人/朋友失望。VIPOS 通过探索患有子宫内膜异位症的女性所经历的症状的异质性以及欧洲各国之间的诊断方法差异，基于真实世界的数据拓宽了我们对子宫内膜异位症的理解。试验注册：ClinicalTrials.gov，NCT01266421；2010 年 12 月 24 日注册。在欧盟电子上市后研究注册系统中注册，编号为 1613。
