基于移动医疗的妊娠期盆底肌训练对产后尿失禁发生的影响：一项基于随机对照试验设计的探索性研究

背景 孕产妇尿失禁（UI）发病率高,严重影响了女性生活质量。研究表明,盆底肌训练是UI有效的防治手段,本研究前期进行了一项随机对照试验（RCT）,结果发现相比于常规宣教,基于移动医疗APP的盆底肌训练并未显现出预防优势,其原因需要进一步深入探讨。 目的 本研究拟对一项基于APP的妊娠期盆底肌训练的干预研究的阴性结果进行探索性分析,旨在探讨产后UI预防效果的影响因素以及获益的亚组人群。 方法 本研究数据来源于前期开展的一项RCT,采用方便抽样法,于2020年6—10月在南方医科大学深圳医院产科门诊招募了126例研究对象,采用随机数字表法分为干预组与对照组,每组各63例。对照组采用常规护理,干预组在此基础上使用"有爱屋"APP进行尿失禁自我管理,干预周期为2个月。产后42 d随访时收集两组产后相关资料,包括产后42 d UI发生情况。以产后是否发生UI为结局指标,将研究对象分为病例组和对照组,采用Logistic回归分析探讨混杂因素及其与干预方式之间的交互作用对产后UI发生的影响。针对Logistic回归分析的结果进行分层分析,探讨是否存在能从APP干预中获益的亚组人群。 结果 病例组和对照组阴道分娩史、入组时存在UI、Broome盆底肌自我效能量表（BPMSES）得分比较,差异均有统计学意义（P<0.05）。Logistic回归分析结果显示,入组时存在UI是产后发生UI的危险因素〔OR=15.897,95%CI（4.724,53.495）,P<0.001〕;BPMSES得分与干预方式的交互作用可影响产后UI的发生〔OR=1.034,95%CI（1.017,1.051）,P<0.001〕。分层分析结果显示,入组时存在UI症状的孕妇,干预组产后UI发生率低于对照组（χ2=4.18,P=0.041）;入组时不存在UI症状的孕妇,两组产后UI发生率比较,差异无统计学意义（χ2=1.89,P=0.284）。 结论 推荐有UI症状的孕妇使用"有爱屋"APP或许可预防产后UI的发生。而对于妊娠期没有UI症状的人群使用"有爱屋"APP预防产后UI发生的证据尚不充分。另外,不管有无UI症状,盆底肌训练自我效能高的孕妇有望从APP干预中获益。

The Effect of a Mobile APP-based Pelvic Floor Muscle Training during Pregnancy on the Occurrence of Postpartum Urinary Incontinence:Exploratory Analysis of a Randomized Controlled Trial

Background The prevalence of urinary incontinence(UI)is high,which greatly affects the quality of life of women.Studies have shown that pelvic floor muscle training(PFMT)is an effective prevention and treatment method.A randomized controlled trial was conducted previously with a result showing absence of a positive effect,when comparing a mobile APP-based pelvic floor muscle training programme with usual care,and the reasons need to be further explored.Objective This study intends to conduct an exploratory analysis of the negative result of a pelvic floor muscle training program during pregnancy based on a mobile APP,aiming to explore the factors affecting the preventive effect of postpartum UI and the subgroups that benefited.Methods The data comes from a randomized controlled trial carried out in the obstetrics clinic of a hospital in Shenzhen from June to October 2020.Convenience sampling technique was adopted to recruit pregnant women.A total of 126 participants were recruited,of which 63 were randomly assigned to intervention group,63 to control group using a random numbers table.The control group received routine nursing care.The intervention group received the usual care plus“UIW”(Urinary Incontinence for Women)APP-based self management of UI.During the 42-day postpartum follow-up,the postpartum related data of the two groups were collected,including the occurrence of UI on the 42nd postpartum day.The subjects were divided into case group and the control group according to the present of postpartum UI.Logistic regression analysis was used to explore the confounding factors and their interaction with intervention methods on the present of postpartum UI.Subgroup analysis based on the results of Logistic regression analysis was performed to explore whether there are subgroups who can benefit from APP intervention.Results There were statistically significant differences in the history of vaginal delivery,the presence of UI at the time of recruitment,and the Broome Pelvic Floor Muscle Self-efficacy Scale(BPMSES)score between the case group and the control group(P<0.05).Logistic regression analysis showed that the presence of UI at the time of recruitment was a significant risk factor for postpartum UI〔OR=15.897,95%CI(4.724,53.495),P<0.001〕.The interaction between BPMSES score and intervention method could affect the occurrence of postpartum UI〔OR=1.034,95%CI(1.017,1.051),P<0.001〕.Further subgroup analysis found that for pregnant women with UI symptoms at the time of enrollment,APP-based intervention showed a better effect of preventing postpartum UI(χ²=4.18,P=0.041),while for pregnant women without UI symptoms at the time of enrollment,the effect did not been observed(χ²=1.89,P=0.284).Conclusion It is recommended that pregnant women with UI symptoms use“UIW”APP to prevent postpartum UI.However,there is insufficient evidence to prevent postpartum UI in people without UI symptoms during pregnancy.In addition,regardless of UI symptoms,pregnant women with high PFMT self-efficacy are expected to benefit from“UIW”APP.