App-Based Treatment in Primary Care for Urinary Incontinence: A Pragmatic, Randomized Controlled Trial

App-Based Treatment in Primary Care for Urinary Incontinence: A Pragmatic, Randomized Controlled Trial
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DOI:
10.1370/afm.2585
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发表时间:
2021-03-01
影响因子:
4.4
通讯作者:
Blanker, Marco H.
Blanker, Marco H.
中科院分区:
医学1区
文献类型:
--
作者:
Loohuis, Anne M. M.;Wessels, Nienke J.;Blanker, Marco H.

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目的基于电子应用程序 (app) 的治疗对于具有良好保守治疗选择的常见疾病很有希望,例如女性尿失禁 (UI),但其与常规护理相比的有效性尚不清楚。本研究旨在确定针对有压力、紧迫感或混合性 UI 的女性,基于应用程序的治疗是否不劣于初级保健机构中的常规护理。 方法 URinControl 试验是荷兰初级保健中的一项务实、非劣效性随机对照试验,研究对象包括每周 2 次 UI 发作的成年女性。从 2015 年 7 月到 2018 年 7 月,我们对 350 名女性进行了资格筛查。根据荷兰全科医生 UI 治疗指南,将基于应用程序的独立盆底肌肉和膀胱训练 (URinControl) 治疗与常规护理进行比较。测量的结果是症状严重程度评分从基线到 4 个月的变化(主要结果)、对特定疾病生活质量的影响、患者感知的改善以及 UI 发作次数。非劣效性(
PURPOSE 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.METHODS 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 diseasespecific quality of life, patient- perceived improvement, and number of UI episodes. Noninferiority (