Department of Obstetrics and Gynecology, Amsterdam University Medical Center - Location AMC, University of Amsterdam, Amsterdam, The Netherlands.
Department of Obstetrics and Gynecology, Spaarne Gasthuis, Hoofddorp, The Netherlands.
BMC Womens Health. 2021 Dec 31;21(1):439. doi: 10.1186/s12905-021-01587-9.
Surgery for pelvic organ prolapse (POP) is associated with high recurrence rates. The costs associated with the treatment of recurrent POP are huge, and the burden from women who encounter recurrent POP, negatively impacts their quality of life. Estrogen therapy might improve surgical outcome for POP due to its potential beneficial effects. It is thought that vaginal estrogen therapy improves healing and long-term maintenance of connective tissue integrity. Hence, this study aims to evaluate the cost-effectiveness of perioperative vaginal estrogen therapy in postmenopausal women undergoing POP surgery.
The EVA trial is a multi-center double-blind randomized placebo-controlled trial conducted in the Netherlands comparing the effectiveness and costs-effectiveness of vaginal estrogen therapy. This will be studied in 300 postmenopausal women undergoing primary POP surgery, with a POP-Q stage of ≥ 2. After randomization, participants administer vaginal estrogen cream or placebo cream from 4 to 6 weeks preoperative until 12 months postoperative. The primary outcome is subjective improvement of POP symptoms at 1 year follow-up, measured with the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcomes are POP-Q anatomy in all compartments, re-interventions, surgery related complications, general and disease specific quality of life, sexual function, signs and complaints of vaginal atrophy, vaginal pH, adverse events, costs, and adherence to treatment. Follow up is scheduled at 6 weeks, 6 months and 12 months postoperative. Data will be collected using validated questionnaires and out-patient visits including gynecological examination performed by an independent gynecologist.
This study investigates whether perioperative vaginal estrogen will be cost-effective in the surgical treatment of POP in postmenopausal women. It is hypothesized that estrogen therapy will show a reduction in recurrent POP symptoms and a reduction in reoperations for POP, with subsequent improved quality of life among women and cost savings. Trial registrationNetherlands Trial Registry: NL6853; registered 19-02-2018, https://www.trialregister.nl/trial/6853 . EudraCT: 2017-003144-21; registered: 24-07-2017.
盆腔器官脱垂（POP）的手术治疗与高复发率相关。治疗复发性 POP 的相关费用巨大，而遭遇复发性 POP 的女性所承受的负担对其生活质量产生负面影响。雌激素治疗可能通过其潜在的有益作用改善 POP 的手术效果。人们认为阴道雌激素治疗可改善愈合和长期维持结缔组织完整性。因此，本研究旨在评估围手术期阴道雌激素治疗在接受 POP 手术的绝经后妇女中的成本效益。
EVA 试验是一项在荷兰进行的多中心、双盲、随机安慰剂对照试验，比较了阴道雌激素治疗对 POP 手术的有效性和成本效益。该试验将纳入 300 名接受原发性 POP 手术且 POP-Q 分期≥2 的绝经后妇女。随机分组后，参与者在术前 4 至 6 周至术后 12 个月内使用阴道雌激素乳膏或安慰剂乳膏。主要结局是 1 年随访时 POP 症状的主观改善，采用患者总体印象改善（PGI-I）量表进行评估。次要结局包括所有隔室的 POP-Q 解剖结构、再次干预、与手术相关的并发症、一般和疾病特异性生活质量、性功能、阴道萎缩的迹象和症状、阴道 pH 值、不良事件、成本以及治疗依从性。计划在术后 6 周、6 个月和 12 个月进行随访。数据将使用经过验证的问卷和包括由独立妇科医生进行的妇科检查的门诊就诊进行收集。
本研究旨在探讨围手术期阴道雌激素治疗绝经后妇女 POP 手术的成本效益。假设雌激素治疗将减少复发性 POP 症状和 POP 的再次手术，从而改善女性的生活质量并节省成本。
荷兰试验注册处：NL6853；注册日期：2018 年 2 月 19 日，https://www.trialregister.nl/trial/6853。EudraCT：2017-003144-21；注册日期：2017 年 7 月 24 日。
