基于APP的国产家用盆底康复仪真实世界回顾性疗效研究  

A real-world retrospective study of pelvic floor muscle training efficacy using an APP-based home device

作　　者：郑吉琼 周士萍 张忠云 钱伟庆 张正望 ZHENG Ji-qiong;ZHOU Shi-ping;ZHANG Zhong-yun;QIAN Wei-qing;ZHANG Zheng-wang(Department of Urology,Huadong Hospital,Fudan University,Shanghai 200040,China)

机构地区：[1]复旦大学附属华东医院泌尿外科,上海200040

出　　处：《复旦学报（医学版）》2024年第1期96-101,共6页Fudan University Journal of Medical Sciences

摘　　要：目的回顾性调查基于APP的国产家用盆底康复仪在真实世界中对盆底功能相关症状的改善情况。方法对2019年10月1日至2021年3月31日期间自由注册并按照关联APP居家使用某国产家用盆底康复仪的171000名18岁以上女性用户进行回顾性调查。通过公共网络平台发布分别针对盆底总体状况、性生活满意度、与松弛型盆底相关之压力性尿失禁(stress urinary incontinence,SUI)、盆腔器官脱垂(pelvic organ prolapse,POP)、阴道松弛(vaginal laxity,VL)共5份患者症状改善印象(Patient Global Impression of Improvement,PGI-I)评分问卷,由用户匿名完成自我疗效评估并上传APP中记录的使用前后阴道肌力值。根据网络后台采集的问卷分值进行疗效评估,并与阴道收缩力作配对分析。结果采用系统抽样法共收集984位用户的有效问卷,分层分析显示:使用时间达到及超过3个月的用户,其盆底总体状况(P=0.0001)、性生活满意度(P=0.009)及SUI(P=0.0001)、POP(P=0.044)、VL(P=0.034)的5项PGI-I评分与不足3个月的用户相比差异均有统计学意义,且SUI、POP的PGI-I分值与阴道肌力间具有配对相关性。而在年龄、教育水平、胎次、分娩方式各亚组中PGI-I评分的差异不具有统计学意义。结论在真实世界中,居家使用3个月及以上基于APP的国产家用盆底康复仪在中国女性人群中可观察到盆底功能相关症状的主观获益及阴道肌力的改善。Objective To retrospectively investigate the efficacy of pelvic floor muscle training(PFMT)using APP-based home device in the real-world scenario.Methods A retrospective survey was conducted among 171000 Chinese female users over 18 years old who freely registered APP and performed PFMT using a domestic manufactured home device from Oct 1,2019 to Mar 31,2021.The Patient Global Impression of Improvement(PGI-I)questionnaires concerning pelvic floor general condition,sexual satisfaction and other three major symptoms related to pelvic floor muscle laxity such as stress urinary incontinence(SUI),pelvic organ prolapse(POP),and vaginal laxity(VL)were broadcast public online for users to self-assess the improvement.The vaginal muscle strength values prior and post training recorded by APP were also reported.All data were collected anonymously for further stratified analysis.Results A total of 984 valid questionnaires were collected by systematic sampling.The PGI-I scores of pelvic floor general condition(P=0.0001),sexual satisfaction(P=0.009),SUI(P=0.0001),POP(P=0.044)and VL(P=0.034)were statistically significant in users who reported to use the device for 3 months or more compared with those less than 3 months.In addition,the increase of vaginal muscle strength was related to the improvement of PGI-I scores in SUI and POP with statistical significance.There were no significant difference in subgroups such as age,education,parity,and delivery mode.Conclusion The subjective benefit of pelvic floor function-related symptoms and the improvement of vaginal muscle strength could be observed after PFMT for three months or more using APP-based home device in Chinese women in the real-world scenario.

关 键 词：盆底功能障碍(PFD) 盆底肌训练 真实世界研究(RWS) APP 

分 类 号：R699.7[医药卫生—泌尿科学]