背景:尽管报告阴道松弛(VL)的女性使用了几种治疗方法,据我们所知,到目前为止,还没有关于这个主题的系统综述。
目的:在本研究中,我们试图总结关于治疗VL的干预措施的有效性和安全性的最佳可用证据,无论是保守的还是手术的。
方法:在Medline中进行了全面的搜索策略,Embase,Scopus,WebofScience,和Cochrane图书馆提供从数据库开始到2022年9月发表的临床试验报告。选择纳入的研究以英语进行,并进行调查VL的任何类型的治疗,有或没有比较器,无论是非随机研究还是随机对照试验(RCTs)。没有明确VL定义的病例报告和研究被排除。
结果:结果是干预措施(激光,射频,手术,和局部治疗),不利影响,性功能,盆底肌肉(PFM)强度,并通过VL问卷(VLQ)对VL进行改进。
结果:来自816条记录,38项研究仍在最后分析中。激光和射频(RF)是最常用的基于能量的治疗设备。来自8项观察性研究的汇总数据显示,女性性功能指数评分平均差异(MD)为6.51(95%CI,5.61-7.42;i2=85%,P<0.01)干预前后,是否通过RF(MD,6.00;95%CI,4.26-7.73;i2=80%;P<.001)或激光(MD,6.83;95%CI,5.01-8.65;i2=92%;P<0.01)。然而,当只纳入3项RCT时,没有显示这一发现,即使通过干预类型(RF或激光)分离。当RF治疗与假对照比较时,VLQ分数没有改善(MD,1.01;95%CI,-0.38至2.40;i2=94%;P<.001)。患者PFM强度在进行干预后得到改善(MD,4.22;95%CI,1.02-7.42;i2=77%;P<.001)。ROBINS-I(非随机干预研究中的偏倚风险)工具将所有非RCT分类为严重偏倚风险,除了一项研究,而偏倚风险-1分析发现,所有随机对照试验的偏倚风险较低且不明确.TheGrade(GradingofRecommendations,评估,发展,和评估)性功能和VLQ问卷的证据确定性中等,PFM强度低。
结论:接受RF和激光治疗的VL女性的性功能在观察性研究中得到改善,但在随机对照试验中没有改善。干预后,在VL女性中观察到PFM强度的改善。
■对于VL的理解提出了重要问题,如缺乏标准化的定义和未来前瞻性研究的发展。该研究的局限性在于干预措施的异质性和不同的随访期无法汇集所有可用数据。
结论:阴道收紧并没有改善VL妇女干预后的感觉,而根据观察性研究的数据,射频和激光改善了VL女性的性功能,但不是来自RCT.VL女性干预后PFM强度提高。
BACKGROUND: Despite several treatments that have been used for women reporting vaginal laxity (VL), to our knowledge no systematic review is available on the topic so far.
OBJECTIVE: In this study, we sought to summarize the best available evidence about the efficacy and safety of interventions for treating VL, whether conservative or surgical.
METHODS: A comprehensive search strategy was performed in Medline, Embase, Scopus, Web of Science, and Cochrane Library for reports of clinical trials published from database inception to September 2022. Studies selected for inclusion were in the English language and were performed to investigate any type of treatment for VL, with or without a comparator, whether nonrandomized studies or randomized controlled trials (RCTs). Case reports and studies without a clear definition of VL were excluded.
RESULTS: The outcomes were interventions (laser, radiofrequency, surgery, and topical treatment), adverse effects, sexual function, pelvic floor muscle (PFM) strength, and improvement of VL by the VL questionnaire (VLQ).
RESULTS: From 816 records, 38 studies remained in the final analysis. Laser and radiofrequency (RF) were the energy-based treatment devices most frequently studied. Pooled data from eight observational studies have shown improved sexual function assessed by a Female Sexual Function Index score mean difference (MD) of 6.51 (95% CI, 5.61-7.42; i2 = 85%, P < .01) before and after intervention, whether by RF (MD, 6.00; 95% CI, 4.26-7.73; i2 = 80%; P < .001) or laser (MD, 6.83; 95% CI, 5.01-8.65; i2 = 92%; P < .01). However, this finding was not shown when only 3 RCTs were included, even when separated by type of intervention (RF or laser). When RF treatment was compared to sham controls, VLQ scores did not improve (MD, 1.01; 95% CI, -0.38 to 2.40; i2 = 94%; P < .001). Patient PFM strength improved after interventions were performed (MD, 4.22; 95% CI, 1.02-7.42; i2 = 77%; P < .001). The ROBINS-I (Risk Of Bias In Nonrandomized Studies of Interventions) tool classified all non-RCTs at serious risk of bias, except for 1 study, and the risk of bias-1 analysis found a low and unclear risk of bias for all RCTs. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) certainty of the evidence was moderate for sexual function and the VLQ questionnaire and low for PFM strength.
CONCLUSIONS: Sexual function in women with VL who underwent RF and laser treatment improved in observational studies but not in RCTs. Improvement in PFM strength was observed in women with VL after the intervention.
UNASSIGNED: Crucial issues were raised for the understanding of VL, such as lack of standardization of the definition and for the development of future prospective studies. A limitation of the study was that the heterogeneity of the interventions and different follow-up periods did not make it possible to pool all available data.
CONCLUSIONS: Vaginal tightening did not improve sensation in women with VL after intervention, whereas RF and laser improved sexual function in women with VL according to data from observational studies, but not from RCTs. PFM strength was improved after intervention in women with VL.