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

Abstract

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.