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
Descripción
Sumario: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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