Related Experiment Video
Updated: Aug 9, 2025
Design to Implementation Study for Development and Patient Validation of Paper-Based Toehold Switch Diagnostics
Published on: June 17, 2022
POWER: an open, single-arm, post-market clinical trial using the TENA SmartCare Change Indicator in a home
Fredrik Agholme1, Artur Lamparski2, Piotr Radziszewski3
1Essity Hygiene and Health AB, Sweden.
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.
Related Concept Videos
01:11Clinical Trials: Overview
01:16Clinical Trials
There are four phases in a clinical trial. A phase one...