دورية أكاديمية
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Real-World Evidence From a Digital Health Treatment Program for Female Urinary Incontinence: Observational Study of Outcomes Following User-Centered Product Design.

التفاصيل البيبلوغرافية
العنوان: Real-World Evidence From a Digital Health Treatment Program for Female Urinary Incontinence: Observational Study of Outcomes Following User-Centered Product Design.
المؤلفون: Hall E; Tufts University Medical Center, Tufts University School of Medicine, Boston, MA, United States., Keyser L; Department of Physical Therapy and Rehabilitation Science, University of California, San Francisco, San Francisco, CA, United States.; Axena Health, Inc., Auburndale, MA, United States., McKinney J; Axena Health, Inc., Auburndale, MA, United States.; College of Health and Human Services, Andrews University, Berrien Springs, MI, United States., Pulliam S; Tufts University Medical Center, Tufts University School of Medicine, Boston, MA, United States.; Axena Health, Inc., Auburndale, MA, United States., Weinstein M; Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States.
المصدر: JMIR formative research [JMIR Form Res] 2024 Jun 27; Vol. 8, pp. e58551. Date of Electronic Publication: 2024 Jun 27.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: JMIR Publications Country of Publication: Canada NLM ID: 101726394 Publication Model: Electronic Cited Medium: Internet ISSN: 2561-326X (Electronic) Linking ISSN: 2561326X NLM ISO Abbreviation: JMIR Form Res Subsets: PubMed not MEDLINE
أسماء مطبوعة: Original Publication: Toronto, ON, Canada : JMIR Publications, [2017]-
مستخلص: Background: Urinary incontinence (UI) affects millions of women with substantial health and quality-of-life impacts. Supervised pelvic floor muscle training (PFMT) 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, although these technologies have not yet been leveraged at scale.
Objective: The primary objective is to describe the effectiveness and safety of a prescribed digital health treatment program to guide PFMT for UI treatment among real-world users. The secondary objectives are to evaluate patient engagement following an updated user platform and identify the factors predictive of success.
Methods: This retrospective cohort study of women who initiated device use between January 1, 2022, and June 30, 2023, included users aged ≥18 years old with a diagnosis of stress, urgency, or mixed incontinence or a score of >33.3 points on the Urogenital Distress Inventory Short Form (UDI-6). Users are prescribed a 2.5-minute, twice-daily, training program guided by an intravaginal, motion-based device that pairs with a smartphone app. Data collected by the device or app include patient-reported demographics and outcomes, adherence to the twice-daily regimen, and pelvic floor muscle performance parameters, including angle change and hold time. Symptom improvement was assessed by the UDI-6 score change from baseline to the most recent score using paired 2-tailed t tests. Factors associated with meeting the UDI-6 minimum clinically important difference were evaluated by regression analysis.
Results: Of 1419 users, 947 met inclusion criteria and provided data for analysis. The mean baseline UDI-6 score was 46.8 (SD 19.3), and the mean UDI-6 score change was 11.3 (SD 19.9; P<.001). Improvement was reported by 74% (697/947) and was similar across age, BMI, and incontinence subtype. Mean adherence was 89% (mean 12.5, SD 2.1 of 14 possible weekly uses) over 12 weeks. Those who used the device ≥10 times per week were more likely to achieve symptom improvement. In multivariate logistic regression analysis, baseline incontinence symptom severity and maximum angle change during pelvic floor muscle contraction were significantly associated with meeting the UDI-6 minimum clinically important difference. Age, BMI, and UI subtype were not associated.
Conclusions: This study provides real-world evidence to support the effectiveness and safety of a prescribed digital health treatment program for female UI. A digital PFMT program completed with visual guidance from a motion-based device yields significant results when executed ≥10 times per week over a period of 12 weeks. The program demonstrates high user engagement, with 92.9% (880/947) of users adhering to the prescribed training regimen. First-line incontinence treatment, when implemented using this digital program, leads to statistically and clinically substantial symptom improvements across age and BMI categories and incontinence subtypes.
(©Evelyn Hall, Laura Keyser, Jessica McKinney, Samantha Pulliam, Milena Weinstein. Originally published in JMIR Formative Research (https://formative.jmir.org), 27.06.2024.)
التعليقات: Erratum in: JMIR Form Res. 2024 Aug 27;8:e65416. doi: 10.2196/65416. (PMID: 39190908)
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فهرسة مساهمة: Keywords: digital health; evidence; mobile phone; pelvic floor muscle training; real-world; urinary incontinence; user-centered design
تواريخ الأحداث: Date Created: 20240627 Latest Revision: 20240827
رمز التحديث: 20240828
مُعرف محوري في PubMed: PMC11240060
DOI: 10.2196/58551
PMID: 38935967
قاعدة البيانات: MEDLINE
الوصف
تدمد:2561-326X
DOI:10.2196/58551