Institute of Metabolism and System Research, University of Birmingham, Birmingham, UK
School of Health and Population Sciences, University of Birmingham, Birmingham, UK.
BMJ Open. 2020 Sep 10;10(9):e025141. doi: 10.1136/bmjopen-2018-025141.
To evaluate the feasibility of a multicentre randomised controlled trial (RCT) comparing oestrogen treatment with no oestrogen supplementation in women undergoing pelvic organ prolapse (POP) surgery.
A randomised, parallel, open, external pilot trial involving six UK urogynaecology centres (July 2015-August 2016).
Postmenopausal women with POP opting for surgery, unless involving mesh or for recurrent POP in same compartment.
Women were randomised (1:1) to preoperative and postoperative oestrogen or no treatment. Oestrogen treatment (oestradiol hemihydrate 10 μg vaginal pessaries) commenced 6 weeks prior to surgery (once daily for 2 weeks, twice weekly for 4 weeks) and twice weekly for 26 weeks from 6 weeks postsurgery.
The main outcomes were assessment of eligibility and recruitment rates along with compliance and data completion. To obtain estimates for important aspects of the protocol to allow development of a definitive trial.
325 women seeking POP surgery were screened over 13 months and 157 (48%) were eligible. Of these, 100 (64%) were randomised, 50 to oestrogen and 50 to no oestrogen treatment, with 89 (44/45 respectively) ultimately having surgery. Of these, 89% (79/89) returned complete questionnaires at 6 months and 78% (32/41) reported good compliance with oestrogen. No serious adverse events were attributable to oestrogen use.
A large multicentre RCT of oestrogen versus no treatment is feasible, as it is possible to randomise and follow up participants with high fidelity. Four predefined feasibility criteria were met. Compliance with treatment regimens is not a barrier. A larger trial is required to definitively address the role of perioperative oestrogen supplementation.
ISRCTN46661996.
评估一项多中心随机对照试验（RCT）的可行性，该试验比较了接受盆腔器官脱垂（POP）手术的女性接受雌激素治疗与不接受雌激素补充治疗的效果。
一项涉及英国 6 个泌尿科妇科中心的随机、平行、开放、外部试验（2015 年 7 月至 2016 年 8 月）。
选择手术治疗 POP 的绝经后妇女，除非涉及网片或同一部位复发性 POP。
将妇女随机（1:1）分为术前和术后雌激素治疗组或无治疗组。雌激素治疗（雌二醇半水合物 10 μg 阴道栓剂）于术前 6 周开始（每天一次持续 2 周，每周两次持续 4 周），术后 6 周开始每周两次持续 26 周。
主要结局是评估合格和招募率，以及依从性和数据完成情况。以获得协议重要方面的估计值，从而制定一项明确的试验。
在 13 个月的时间内，对 325 名接受 POP 手术的妇女进行了筛查，其中 157 名（48%）合格。其中，100 名（45 名/45 名）被随机分为雌激素组和无雌激素组，最终有 89 名（44 名/45 名）接受了手术。其中，89%（79/89）在 6 个月时返回了完整的问卷，78%（32/41）报告了雌激素的良好依从性。没有与雌激素使用相关的严重不良事件。
一项大型多中心 RCT 比较雌激素与无治疗是可行的，因为可以高保真度地对参与者进行随机分组和随访。四项预设的可行性标准得到满足。治疗方案的依从性不是障碍。需要更大规模的试验来明确解决围手术期雌激素补充的作用。
ISRCTN46661996。
