NCT04846270

Investigation of the Ability of the TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products

An Open, Single-arm, Post-market Clinical Investigation to Verify the Ability of TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products in a Home Environment.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Essity Hygiene and Health AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this post market clinical investigation is to demonstrate the performance and safety of the TENA SmartCare Change Indicator.

Detailed description

The TENA SmartCare Change Indicator is intended for use on individuals, dependent end user (DEU), suffering from Urinary Incontinence (UI) who are cared for in a home environment, by one or more caregivers (CGR). The TENA SmartCare Change Indicator is an accessory to TENA absorbing incontinence products. This clinical investigation is intended to demonstrate that use of TENA SmartCare Change Indicator has the ability to reduce the number of manual checks between daily changes of absorbing incontinence products. Secondarily, the investigation will evaluate number of leakages, skin redness, usability and fecal incidence. Furthermore, the safety will continuously be monitored through analyzing device-related adverse events reported during the investigation.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	TENA SmartCare Change Indicator	Each participating subject will be provided with TENA SmartCare Change Indicator and incontinence products for the duration of the investigation. Each participating subject will be allocated to the incontinence type(s) that are considered most suitable.

Timeline

• Start date: 2021-04-14
• Primary completion: 2021-10-28
• Completion: 2021-10-28
• First posted: 2021-04-15
• Last updated: 2024-04-08
• Results posted: 2024-04-08

Locations

1 site across 1 country: Poland