Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands
Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
Ann Fam Med. 2021 Mar-Apr;19(2):102-109. doi: 10.1370/afm.2585.
Electronic application (app)-based treatment is promising for common diseases with good conservative management options, such as urinary incontinence (UI) in women, but its effectiveness compared with usual care is unclear. This study set out to determine if app-based treatment for women with stress, urgency, or mixed UI was noninferior to usual care in the primary care setting.
The URinControl trial is a pragmatic, noninferiority randomized controlled trial in Dutch primary care including adult women with 2 episodes of UI per week. From July 2015 to July 2018, we screened 350 women for eligibility. A stand-alone app-based treatment with pelvic floor muscle and bladder training (URinControl) was compared with usual care according to the Dutch general practitioner guideline for UI treatment. Outcomes measured were change in symptom severity score from baseline to 4 months (primary outcome), impact on disease-specific quality of life, patient-perceived improvement, and number of UI episodes. Noninferiority (<1.5 points) was assessed with linear regression analysis.
A total of 262 eligible women were randomized equally; 195 of them had follow-up through 4 months. The change in symptom severity with app-based treatment (-2.16 points; 95% CI, -2.67 to -1.65) was noninferior to that with usual care (-2.56 points; 95% CI, -3.28 to -1.84), with a mean difference of 0.058 points (95% CI, -0.776 to 0.891) between groups. Neither treatment was superior to the other, and both groups showed improvements in outcome measures after treatment.
App-based treatment for women with UI was at least as effective as usual care in the primary care setting. As such, app-based treatments, with their potential advantages of privacy, accessibility, and lower cost, may provide women with a good alternative to consultation.
电子应用（app）为基础的治疗方法在具有良好保守治疗选择的常见疾病（如女性尿失禁（UI））中具有广阔前景，但与常规护理相比，其效果尚不清楚。本研究旨在确定基于 app 的治疗方法是否与常规护理在初级保健环境中对女性压力性、紧迫性或混合性 UI 无效。
URinControl 试验是一项在荷兰初级保健中进行的实用性、非劣效性随机对照试验，纳入每周出现 2 次 UI 的成年女性。从 2015 年 7 月至 2018 年 7 月，我们对 350 名女性进行了筛选，以确定其是否符合条件。一种独立的基于 app 的治疗方法，包括盆底肌和膀胱训练（URinControl），与根据荷兰普通科医生 UI 治疗指南的常规护理进行了比较。测量的结果是从基线到 4 个月时症状严重程度评分的变化（主要结果）、对疾病特异性生活质量的影响、患者感知的改善以及 UI 发作次数。使用线性回归分析评估非劣效性（<1.5 分）。
共有 262 名符合条件的女性被平均分配至两组，每组 131 人；其中 195 名女性在 4 个月时进行了随访。基于 app 的治疗组（-2.16 分；95%CI，-2.67 至-1.65）的症状严重程度变化与常规护理组（-2.56 分；95%CI，-3.28 至-1.84）相比非劣效，两组间的平均差异为 0.058 分（95%CI，-0.776 至 0.891）。两种治疗方法均无优越性，两组在治疗后均显示出改善。
基于 app 的 UI 治疗在初级保健环境中与常规护理一样有效。因此，基于 app 的治疗方法具有隐私性、可及性和更低成本的潜在优势，可能为女性提供了一种替代咨询的良好选择。
