Department of Nursing, Shenzhen Hospital, Southern Medical University, Shenzhen, China.
School of Nursing, Southern Medical University, Guangzhou, China.
J Med Internet Res. 2023 Jun 27;25:e43528. doi: 10.2196/43528.
Urinary incontinence (UI) is a highly prevalent health concern commonly observed during and after pregnancy that can substantially impact women's physical and psychological well-being and quality of life. Owing to its numerous advantages, mobile health may be a promising solution; however, it is unclear whether the app-based intervention can effectively improve UI symptoms during and after pregnancy.
This study aimed to evaluate the effectiveness of the Urinary Incontinence for Women (UIW) app-based intervention for UI symptom improvement among pregnant women in China.
Singleton pregnant women without incontinence before pregnancy who were aged ≥18 years and between 24 and 28 weeks of gestation were recruited from a tertiary public hospital in China and were randomly allocated (1:1) to either an experimental group (n=63) or a control group (n=63). The experimental group received the UIW app intervention and oral pelvic floor muscle training (PFMT) instructions, whereas the control group received oral PFMT instructions alone. Neither the participants nor the researchers were blinded to the intervention. The primary outcome was UI severity. The secondary outcomes included quality of life, self-efficacy with PFMT, and knowledge of UI. All data were collected at baseline, 2 months after randomization, and 6 weeks post partum through electronic questionnaires or by checking the electronic medical record system. Data analysis followed the intention-to-treat principle. A linear mixed model was used to examine the intervention effect on primary and secondary outcomes.
Participants in the experimental and control groups were comparable at baseline. Of the 126 overall participants, 117 (92.9%) and 103 (81.7%) women completed follow-up visits at 2 months after randomization and 6 weeks after delivery, respectively. A statistically significant difference in UI symptom severity was observed between the experimental group and control group (2 months after randomization: mean difference -2.86, 95% CI -4.09 to -1.64, P<.001; 6 weeks post partum: mean difference -2.68, 95% CI -3.87 to -1.49, P<.001). For the secondary outcomes, a statistically significant intervention effect on the quality of life, self-efficacy, and UI knowledge was found at the 2-month follow-up (all P<.05) and 6 weeks post partum (all P<.001).
The app-based UI self-management intervention (UIW) effectively improved UI symptom severity, quality of life, self-efficacy with PFMT, and knowledge of UI during the late pregnancy and early postnatal periods. Larger multicenter studies with a longer postpartum follow-up are required to further extend these findings.
Chinese Clinical Trial Registry ChiCTR1800016171; http://www.chictr.org.cn/showproj.aspx?proj=27455.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/22771.
尿失禁（UI）是一种高发的健康问题，常发生于妊娠期间及妊娠后，可极大地影响女性的身心健康和生活质量。移动医疗具有诸多优势，可能是一种很有前景的解决方案；但尚不清楚基于应用程序的干预措施是否能有效改善妊娠期间及妊娠后的 UI 症状。
本研究旨在评估基于应用程序的“女性尿失禁（UIW）”干预措施对中国孕妇 UI 症状的改善效果。
本研究纳入了年龄≥18 岁、妊娠 24~28 周的无妊娠前 UI 的单胎孕妇，她们均来自中国一家三级公立医院，并被随机分配（1:1）至实验组（n=63）或对照组（n=63）。实验组接受 UIW 应用程序干预和口服盆底肌训练（PFMT）指导，而对照组仅接受口服 PFMT 指导。参与者和研究人员均未对干预措施设盲。主要结局为 UI 严重程度。次要结局包括生活质量、PFMT 自我效能和 UI 知识。所有数据均通过电子问卷或检查电子病历系统，于基线、随机分组后 2 个月和产后 6 周收集。数据分析遵循意向治疗原则。采用线性混合模型检验主要和次要结局的干预效果。
实验组和对照组的参与者在基线时具有可比性。在 126 名总体参与者中，117 名（92.9%）和 103 名（81.7%）女性分别在随机分组后 2 个月和产后 6 周完成了随访。实验组和对照组的 UI 症状严重程度存在统计学显著差异（随机分组后 2 个月：平均差值-2.86，95%置信区间-4.09 至-1.64，P<.001；产后 6 周：平均差值-2.68，95%置信区间-3.87 至-1.49，P<.001）。对于次要结局，在 2 个月随访时（均 P<.05）和产后 6 周时（均 P<.001），干预对生活质量、PFMT 自我效能和 UI 知识均具有统计学显著的效果。
基于应用程序的 UI 自我管理干预（UIW）可有效改善妊娠晚期和产后早期的 UI 症状严重程度、生活质量、PFMT 自我效能和 UI 知识。需要更大规模的多中心研究和更长时间的产后随访来进一步扩展这些发现。
中国临床试验注册中心 ChiCTR1800016171；http://www.chictr.org.cn/showproj.aspx?proj=27455。
国际标准化报告标识符（IRRID）：RR2-10.2196/22771。
