Effects of intravaginal conjugated oestrogen on pessary continuation for pelvic organ prolapse: multicentre, randomised, double blind, placebo controlled trial.

Methods

Multicentre, randomised, double blind, placebo controlled trial.

多中心、随机、双盲、安慰剂对照试验。

12 academic medical centres in China (May 2020-June 2023).

在中国的12家学术医疗中心（2020年5月至2023年6月）。

Postmenopausal women with symptomatic pelvic organ prolapse ≥stage 2 and successfully fitted with ring pessaries were randomly assigned in a 1:1 ratio to receive oestrogen cream or placebo cream.

成功佩戴环形子宫托的绝经后妇女，如有症状的盆腔器官脱垂≥2期，按1:1的比例随机分配接受雌激素乳膏或安慰剂乳膏治疗。

One gram of conjugated oestrogen cream (0.625 mg/g) or placebo cream was inserted vaginally every night for the first two weeks after successful pessary fitting followed by twice weekly for 12 months.

成功放置子宫托后，每晚使用1克结合雌激素软膏（0.625 mg/g）或安慰剂软膏，前两周每晚使用，随后12个月每周两次。

The primary outcome was the pessary continuation rate with satisfaction, which was defined as the proportion of participants who continued using the pessary and reported a response of very much better or much better on the Patient Global Impression of Improvement questionnaire at 12 months.

主要结果是子宫托的持续使用率和满意度，这被定义为在12个月时继续使用子宫托并且在患者全球改善印象问卷上报告非常改善或明显改善的参与者比例。

Secondary outcomes included self-reported pelvic floor symptoms and adverse events.

次要结果包括自我报告的盆底症状和不良事件。

All analyses were based on a modified intention-to-treatapproach, including participants who had at least one visit.

所有分析均基于修改后的意向治疗分析方法，包括至少参加过一次随访的参与者。

Results

Of 420 postmenopausal women randomised, 411 had at least one visit and were included in the modified intention-to-treatanalysis (208 in the vaginal oestrogen group and 203 in the placebo group).

在随机分配的420名绝经后妇女中，有411名至少参加了一次随访，并被纳入修改后的意向治疗分析（阴道雌激素组208人，安慰剂组203人）。

The mean age of participants was 66 years.

参与者的平均年龄为66岁。

Pessary continuation rate with satisfaction did not differ significantly between the oestrogen group and the placebo group (181/208 (87.0%) v 176/203 (86.7%); risk difference 0.3%, 95% confidence interval-6.2% to 6.9%; P=0.92).

雌激素组与安慰剂组的子宫托继续使用率和满意度之间没有显著差异（181/208 (87.0%) 对比 176/203 (86.7%); 风险差异 0.3%，95% 置信区间 -6.2% 至 6.9%；P=0.92）。

Excessive discharge (34/208 (16.3%) v 52/203 (25.6%); -9.3%, -17.1% to -1.4%), vaginal erosion or ulcer (4/208 (1.9%) v 14/203 (6.9%); -5.0%, -8.9% to -1.0%), and vaginal bleeding (3/208 (1.4%) v 13/203 (6.4%); -5.0%, -8.7% to -1.2%) were less common in the vaginal oestrogen group.

在阴道雌激素组中，过多分泌物（34/208 (16.3%) 对比 52/203 (25.6%); -9.3%，-17.1% 至 -1.4%）、阴道侵蚀或溃疡（4/208 (1.9%) 对比 14/203 (6.9%); -5.0%，-8.9% 至 -1.0%）以及阴道出血（3/208 (1.4%) 对比 13/203 (6.4%); -5.0%，-8.7% 至 -1.2%）的发生率较低。

Conclusions

Oestrogen cream did not improve the continuation rate of ring pessary use with satisfaction.

雌激素霜未能提高环形子宫托使用满意度的持续率。

Use of oestrogen cream might be associated with a lower risk of common adverse events.

使用雌激素霜可能与较低的常见不良事件风险相关。

The clinical decision to use vaginal oestrogen should take into account its benefits and risks and the patient's personal preferences.

在决定使用阴道雌激素时，应考虑其益处和风险以及患者的个人偏好。

trial_registration

ClinicalTrials.gov NCT04393194.

ClinicalTrials.gov NCT04393194。