Accepted for/Published in: JMIR Formative Research
Date Submitted: Mar 18, 2024
Date Accepted: May 30, 2024
Warning: This is an author submission that is not peer-reviewed or edited.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.
A digital health treatment program for urinary incontinence: Real-world evidence from users of a motion-based device to guide pelvic floor muscle training
ABSTRACT
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. Clinical Trial: N/A - retrospective study
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