POWER：一项在家庭环境中使用得伴智能护理更换指示器的开放性单臂上市后临床试验。
POWER: an open, single-arm, post-market clinical trial using the TENA SmartCare Change Indicator in a home environment.
作者信息
Agholme Fredrik, Lamparski Artur, Radziszewski Piotr
机构信息
Essity Hygiene and Health AB, Sweden.
Medical Concierge, Poland.
出版信息
Arch Med Sci. 2023 Jan 13;19(1):270-273. doi: 10.5114/aoms/158568. eCollection 2023.
INTRODUCTION
This clinical trial tested the use of the TENA SmartCare Change Indicator in a homecare environment.
METHODS
The trial included 35 elderly subjects with urinary incontinence. The trial lasted for 3 weeks. The primary outcome was the reduction in manual absorbing product checks between the baseline (first) and the investigational (third) week.
RESULTS
The numbers of checks and leakages were significantly reduced by 16% ( = 0.001) and 40% ( = 0.0051).
CONCLUSIONS
Use of the device led to a reduction in the numbers of manual checks and leakages. The device appears to be safe, well tolerated and easy to use.
引言
本临床试验在家庭护理环境中测试了得伴智能护理更换指示器的使用情况。
方法
该试验纳入了35名老年尿失禁患者。试验持续3周。主要结局是基线（第一）周和研究（第三）周之间手动吸收性产品检查次数的减少。
结果
检查次数和漏尿次数显著减少，分别减少了16%（P = 0.001）和40%（P = 0.0051）。
结论
使用该设备可减少手动检查次数和漏尿次数。该设备似乎安全、耐受性良好且易于使用。
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