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

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.

Keywords

• urinary incontinence
• cognitive impairment
• clinical trial
• leakages
• new device
• manual check
• skin irritation