UROLOGY / RESEARCH LETTER
POWER: an open, single-arm, post-market clinical trial using the TENA SmartCare Change Indicator in a home environment
| 1 | Essity Hygiene and Health AB, Sweden |
| 2 | Medical Concierge, Poland |
| 3 | Department of Urology, Warsaw Medical University, Poland |
CORRESPONDING AUTHOR
Submission date: 2022-11-08
Final revision date: 2022-12-16
Acceptance date: 2022-12-27
Online publication date: 2023-01-13
Publication date: 2023-01-01
Arch Med Sci 2023;19(1):270–273
KEYWORDS
TOPICS
ABSTRACT
Introduction:
This clinical trial test the use of the TENA SmartCare Change Indicator in a homecare environment.
Material and 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 baseline (first) and investigational (third) week.
Results:
The number of checks and leakages were significantly reduced by 16% (p = 0.001) and 40% (p = 0.0051).
Conclusions:
Use of the device lead to a reduction in numbers of manual checks and leakages. The device appears to be safe, well-tolerated and easy to use.
This clinical trial test the use of the TENA SmartCare Change Indicator in a homecare environment.
Material and 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 baseline (first) and investigational (third) week.
Results:
The number of checks and leakages were significantly reduced by 16% (p = 0.001) and 40% (p = 0.0051).
Conclusions:
Use of the device lead to a reduction in numbers of manual checks and leakages. The device appears to be safe, well-tolerated and easy to use.
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