背景:尿失禁(UI)影响着数百万对健康和生活质量有重大影响的女性。有监督的盆底肌肉训练(PFMT)是推荐的一线治疗方法。然而,多重个人和制度障碍阻碍了妇女获得熟练护理。有证据表明,数字医疗解决方案是可以接受的,并且可能有效地提供一线失禁治疗,尽管这些技术尚未得到大规模利用。
目的:主要目的是描述规定的数字健康治疗计划的有效性和安全性,以指导PFMT在现实世界用户中进行UI治疗。次要目标是在更新的用户平台之后评估患者参与度,并确定预测成功的因素。
方法:这项针对2022年1月1日至2023年6月30日期间开始使用设备的女性的回顾性队列研究,包括年龄≥18岁并诊断为压力的使用者,紧迫性,或混合性尿失禁或在泌尿生殖器窘迫量表简表(UDI-6)上得分>33.3分。用户被规定为2.5分钟,每天两次,由阴道内引导的训练计划,与智能手机应用程序配对的基于运动的设备。设备或应用程序收集的数据包括患者报告的人口统计和结果,坚持每天两次的治疗方案,和盆底肌肉性能参数,包括角度变化和保持时间。使用配对双尾t检验,通过从基线到最新评分的UDI-6评分变化来评估症状改善。通过回归分析评估与满足UDI-6最小临床重要差异相关的因素。
结果:在1419个用户中,947符合纳入标准,并提供了分析数据。平均基线UDI-6评分为46.8(SD19.3),平均UDI-6评分变化为11.3(SD19.9;P<.001)。据报道,改善率为74%(697/947),不同年龄的情况相似,BMI,和失禁亚型。在12周内,平均依从性为89%(14次可能的每周使用平均12.5,SD2.1)。那些每周使用该设备≥10次的人更有可能实现症状改善。在多变量逻辑回归分析中,基线尿失禁症状严重程度和盆底肌肉收缩期间的最大角度变化与满足UDI-6最小临床重要差异显著相关.年龄,BMI,和UI子类型没有关联。
结论:这项研究提供了现实世界的证据来支持针对女性UI的规定数字健康治疗计划的有效性和安全性。在基于运动的设备的视觉指导下完成的数字PFMT程序在12周内每周执行≥10次时会产生显着的结果。该计划展示了高用户参与度,92.9%(880/947)的用户遵守规定的培训方案。一线尿失禁治疗,当使用这个数字程序实现时,导致年龄和BMI类别以及失禁亚型的统计学和临床症状改善。
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.