POWER: an open, single-arm, post-market clinical trial using the TENA SmartCare Change Indicator in a home environment

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...

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Detalles Bibliográficos
Autores principales: Agholme, Fredrik, Lamparski, Artur, Radziszewski, Piotr
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Termedia Publishing House 2023
Materias:
Research Letter
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9897102/
https://www.ncbi.nlm.nih.gov/pubmed/36817679
http://dx.doi.org/10.5114/aoms/158568
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author Agholme, Fredrik
Lamparski, Artur
Radziszewski, Piotr
author_facet Agholme, Fredrik
Lamparski, Artur
Radziszewski, Piotr
author_sort Agholme, Fredrik
collection PubMed
description 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% (p = 0.001) and 40% (p = 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.
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spelling pubmed-98971022023-02-16 POWER: an open, single-arm, post-market clinical trial using the TENA SmartCare Change Indicator in a home environment Agholme, Fredrik Lamparski, Artur Radziszewski, Piotr Arch Med Sci Research Letter 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% (p = 0.001) and 40% (p = 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. Termedia Publishing House 2023-01-13 /pmc/articles/PMC9897102/ /pubmed/36817679 http://dx.doi.org/10.5114/aoms/158568 Text en Copyright: © 2023 Termedia & Banach https://creativecommons.org/licenses/by-nc-sa/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0) License, allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.
spellingShingle Research Letter
Agholme, Fredrik
Lamparski, Artur
Radziszewski, Piotr
POWER: an open, single-arm, post-market clinical trial using the TENA SmartCare Change Indicator in a home environment
title POWER: an open, single-arm, post-market clinical trial using the TENA SmartCare Change Indicator in a home environment
title_full POWER: an open, single-arm, post-market clinical trial using the TENA SmartCare Change Indicator in a home environment
title_fullStr POWER: an open, single-arm, post-market clinical trial using the TENA SmartCare Change Indicator in a home environment
title_full_unstemmed POWER: an open, single-arm, post-market clinical trial using the TENA SmartCare Change Indicator in a home environment
title_short POWER: an open, single-arm, post-market clinical trial using the TENA SmartCare Change Indicator in a home environment
title_sort power: an open, single-arm, post-market clinical trial using the tena smartcare change indicator in a home environment
topic Research Letter
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9897102/
https://www.ncbi.nlm.nih.gov/pubmed/36817679
http://dx.doi.org/10.5114/aoms/158568
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