Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Oct 14, 2022
Date Accepted: May 27, 2023
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Effect of Mobile App-Based Urinary Incontinence Self-Management Intervention Among Pregnant Women in China: Pragmatic Randomized Controlled Trial
ABSTRACT
Background:
Urinary incontinence (UI) is a highly prevalent health concern during and after pregnancy that can have a significant impact on women's physical and psychological well-being and quality of life. Mobile health (mHealth) may be a promising solution with potential advantages. However, it is unclear whether the app-based intervention is effective for UI symptom improvement during and after pregnancy.
Objective:
We developed an app named UIW (Urinary Incontinence for Women) aiming at improving perinatal UI self-management. The objective of this study is to evaluate the efficiency of UIW app-based intervention in UI symptom improvement among pregnant women in China.
Methods:
Pregnant women were recruited from a tertiary public hospital in China. The participants were randomly allocated (1:1) to either an experimental group receiving UIW app intervention plus usual care (n=63) or a control group receiving usual care alone (n=63). Neither the participants nor the researchers were blinded to the intervention. The intervention period will last 2 months. The primary outcome was the severity of UI. Secondary outcomes included quality of life, self-efficacy with PFMT, and knowledge of UI. All data were collected at baseline, at 2 months after the intervention began, and 6 weeks postpartum follow-up through electronic questionnaires or by checking the electronic medical records system. The data analysis followed the intention-to-treat principle. A linear mixed model was used to examine the intervention effect on primary and secondary outcomes.
Results:
Participants in the experimental and control groups were comparable at baseline; about 117 women (92.9%) and 103 (81.7%) participants completed follow-up visits at 2 months post-intervention and 6 weeks after delivery, respectively. The participants in the experimental group, when compared with the control group, showed significant improvement in UI symptom severity (2 months post-intervention: mean difference -2.37, 95% CI -3.78 to -0.95, P=.001; 6 weeks postpartum: mean difference -2.65, 95% CI -4.07 to -1.23, P<.001). For the secondary outcomes, greater self-efficacy and UI knowledge were shown at 2 months follow-up (P<.001) and 6 weeks postpartum (P<.001); however, a statistically significant intervention effect on the quality of life was detected only at 6 weeks after delivery (P<.001), but not at 2 months post-intervention (P=.13).
Conclusions:
The app-based UI self-management intervention (UIW) effectively improved UI symptom severity, quality of life, self-efficacy with pelvic floor muscle training, and knowledge of UI during the late pregnancy and early postnatal period. Larger multicenter studies with a longer postpartum follow-up are required to extend these findings. Clinical Trial: Chinese Clinical Trial Registry ChiCTR1800016171; http://www.chictr.org.cn/showproj.aspx?proj=27455
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