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.

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

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warszawa, Poland, 02-798
    • Medical Concierge Centrum Medyczne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. DEU is diagnosed with urinary incontinence managed with a tape-style incontinence product.
2. DEU is unable to sufficiently communicate the need for an incontinence product to be changed.
3. DEU is being cared for in a home environment and most of the care is provided by a main CGR.
4. DEU is willing and able to provide informed consent and to participate in the clinical investigation or has a legally designated representative willing to provide informed consent on behalf of the DEU. Note, the legally designated representative and main CGR cannot be the same person.
5. CGR is willing and able to provide informed consent to participate in the clinical investigation.
6. The CGR frequently checks the saturation level of the incontinence product, manually and/or by a touch-feel process.
7. If incontinence is managed by pharmaceuticals, the dose regime is stable.
8. DEU and CGR ≥ 18 years of age.

Exclusion Criteria:

1. DEU is cared for in a professional establishment or is institutionalized.
2. DEU has ≥ 4 fecal "incidences" per week.
3. DEU has severe incontinence product related skin problems, as judged by the investigator.
4. DEU has any type of urinary catheter(s) resulting in improved/treated urinary incontinence.
5. The incontinence product is changed on a routine based on time (schedule) or device alert, without manual checks.
6. Any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
7. CGR is incapable or unwilling to use the required smart phone application and/or the diary registration webpage required for the clinical investigation.
8. Participation in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the course of the clinical investigation.
9. DEU is pregnant or nursing.
10. CGR or DEU with an alcohol or drug addiction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Device; TENA SmartCare Change Indicator	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Manual Checks Per Day at Baseline Week and 3 Weeks	A comparison between the average number of manual checks, in-between the regular changes of the absorbing incontinence product, in the third week of the study (investigational week) and the first week of the study (baseline week).	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Safety Related Events	Reported number of adverse events (AE), adverse device effects (ADE), serious adverse events (SAE), serious adverse device effects (SADE), and device deficiency (DD) as reported in the investigation.	3 weeks
Number of Leakages Per Day Into the Clothes and/or Bed Linen at Baseline and 3 Weeks	A comparison between the average number of urine leakages (out of the absorbing incontinence product), onto the clothes and/or bed linen, in the third week of the study (investigational week) and the first week of the study (baseline week).	3 weeks
Number of Participants With Skin Redness and Irritation	A comparison between investigational (week 3) week and baseline week (week 1). The Ghent Global IAD Categorisation Tool (GlOBIAD) was used. It has a 4 point scale from minimum 1A to maximum 2B (with 1A being better outcome). In the measure. IAD is incontinence associated dermatitis.	3 weeks
Usability Assessed Via Caregiver-reported Questions With a Qualitative Scale at the End of the Study.	Average score is presented. The scale is 5-point, from minimum 1 to maximum 5 (with 5 being the better outcome).	At the end of investigational week (week 3).
Number of Fecal Incidences.	Presented in listing. No formal endpoint. Will only be used for assessing reliable primary endpoint measurements.	3 weeks

Collaborators and Investigators

• Sponsor: Essity Hygiene and Health AB
• Investigators: Principal Investigator: Prof. Piotr Radziszewski, MD, PhD, Medical Concierge Centrum Medyczne, Polnej Rózy 6/U2, 02-798 Warszawa,

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Actual): October 28, 2021
• Study Completion (Actual): October 28, 2021

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence
• Other Study ID Numbers: POWER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No