Mobile App-Based Self-Management of Urinary Incontinence in Pregnant Women: Multicenter Pragmatic Randomized Controlled Trial.

Background: Urinary incontinence (UI) is a common condition during pregnancy, significantly impacting the physical and mental well-being as well as quality of life. With advancements in mobile health technology, mobile apps provide innovative approaches for managing UI. Although small-scale studies have demonstrated their efficacy in alleviating maternal UI symptoms, there is a notable lack of large-scale, multicenter trials to validate these findings. Objective: This multicenter randomized controlled trial evaluated the effectiveness of a mobile app ("Urinary Incontinence for Women") for self-management of UI among pregnant women. Methods: A total of 295 participants were recruited from obstetric clinics at 5 hospitals and randomized to either a 12-week mobile app-based intervention group (n=148) or a standard care group (n=147). The primary outcome was UI symptom severity, with secondary outcomes of the impact of UI on quality of life and self-efficacy in pelvic floor muscle training (PFMT). Assessments were conducted at baseline, postintervention (12 weeks), and 6-8 weeks postpartum via electronic questionnaires. Generalized estimating equation modeling was used to evaluate the intervention effects. Subgroup analyses were performed to examine intervention effects across different baseline characteristics. Results: A total of 267 participants (267/295, 90.5%) completed all assessments. The intervention group showed significantly improved UI symptom severity compared with controls postintervention (β=-.97, 95% CI -1.85 to -0.08; P=.03), with further improvement at 6-8 weeks postpartum (β=-1.93, 95% CI -2.70 to -1.17; P<.001). The impact of UI on quality of life also improved in the intervention group postintervention (β=-1.05, 95% CI -1.95 to -0.15; P=.048) and at 6-8 weeks postpartum (β=-1.72, 95% CI -2.46 to -0.98; P<.001). No significant between-group difference was observed in PFMT self-efficacy (β=1.49, 95% CI -2.93 to 5.90; P=.51), which decreased significantly from postintervention to 6-8 weeks postpartum (β=-4.66, 95% CI -8.11 to -1.22; P=.008). Subgroup analyses revealed significant interactions between intervention effects and education level, PFMT performing before enrollment, history of vaginal delivery, and baseline UI symptoms. Conclusions: The "Urinary Incontinence for Women" app-based self-management strategies significantly improved UI symptom severity and quality of life in pregnant and postpartum women, with pronounced effects in certain subgroups based on education level and baseline UI status. While PFMT self-efficacy was not enhanced, the app's benefits underscore the clinical relevance of personalized UI management.