A digital health treatment program for urinary incontinence: Real-world evidence from users of a motion-based device to guide pelvic floor muscle training (Preprint)

BACKGROUND Urinary incontinence affects millions of women with significant health and quality of life impacts. Supervised pelvic floor muscle training is the recommended first-line treatment; however, multiple individual and institutional barriers impede women’s access to skilled care. Evidence suggests that digital health solutions are acceptable and may be effective in delivering first-line incontinence treatment, though, these technologies have not yet been leveraged at scale. OBJECTIVE To describe the effectiveness and safety of a prescribed digital health treatment program to guide pelvic floor muscle training for urinary incontinence treatment among real-world users. METHODS This retrospective cohort study of women who initiated device use January 1, 2022—June 30, 2023 included users ≥18 years old with stress, urgency, or mixed incontinence or UDI-6–Urogenital Distress Inventory, Short Form score ≥33.3 points were included. Users are prescribed a 2.5-minute, twice daily training program guided by an intravaginal, motion-based device that pairs with smartphone application. Data collected by the device/application includes patient-reported demographics and outcomes, adherence, and muscle performance. Symptom improvement was assessed by UDI-6 score change from baseline to most recent score using paired t-tests. Factors associated with meeting UDI-6 minimum clinically important difference were evaluated by regression analysis. RESULTS Of 1419 users, 947 met inclusion criteria and provided data for analysis. Mean baseline UDI-6 score was 46.8±19.3; mean UDI-6 score change was 11.3±19.9 (P <0.001). Improvement was reported by 74% (697/947) and similar across age, body mass index, and incontinence subtype. Mean adherence was 89% (12.5±2.1 of 14 possible weekly uses) over 12 weeks; those who used the device 10+ times/week were more likely to achieve symptom improvement. CONCLUSIONS This study provides real-world evidence to support the effectiveness and safety of a prescribed digital health treatment program using a motion-based device. First-line incontinence treatment when implemented using this digital program yields statistically and clinically significant symptom improvements across age and BMI categories and UI subtypes. CLINICALTRIAL N/A - retrospective study