Back to resultsInvestigation of the Ability of the TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
TENA SmartCare Change Indicator
Sponsored by
About this trial
This is an interventional supportive care trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- DEU is diagnosed with urinary incontinence managed with a tape-style incontinence product.
- DEU is unable to sufficiently communicate the need for an incontinence product to be changed.
- DEU is being cared for in a home environment and most of the care is provided by a main CGR.
- 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.
- CGR is willing and able to provide informed consent to participate in the clinical investigation.
- The CGR frequently checks the saturation level of the incontinence product, manually and/or by a touch-feel process.
- If incontinence is managed by pharmaceuticals, the dose regime is stable.
- DEU and CGR ≥ 18 years of age.
Exclusion Criteria:
- DEU is cared for in a professional establishment or is institutionalized.
- DEU has ≥ 4 fecal "incidences" per week.
- DEU has severe incontinence product related skin problems, as judged by the investigator.
- DEU has any type of urinary catheter(s) resulting in improved/treated urinary incontinence.
- The incontinence product is changed on a routine based on time (schedule) or device alert, without manual checks.
- Any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
- CGR is incapable or unwilling to use the required smartphone application and/or the diary registration webpage required for the clinical investigation.
- 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.
- DEU is pregnant or nursing.
- CGR or DEU with an alcohol or drug addiction
Sites / Locations
- Medical Concierge Centrum Medyczne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Investigational Device
Arm Description
TENA SmartCare Change Indicator
Outcomes
Primary Outcome Measures
Change in the number of manual checks
A comparison between investigational week (week 3) and baseline week (week 1) in the average number of manual checks in-between the daily changes of the absorbing incontinence product.
Secondary Outcome Measures
Incidence of adverse events (AE), adverse device effects (ADE), serious adverse events (SAE), serious adverse device effects (SADE), and device deficiency (DD) during learning week (week 2) and investigational week (week 3).
Number of incidents during the investigation
Change in the number of leakages into the clothes and/or bed linen
A comparison between investigational week (week 3) and baseline week (week 1) in the number of leakages into the clothes and/or bed linen.
Assessment of skin redness and irritation (GLOBIAD scoring)
A comparison between investigational (week 3) week and baseline week (week 1). GlOBIAD is a 4 point scale from minimum 1A to maximum 2B (with 1A being better outcome).
Usability questionnaire: Overall usability assessed via caregiver-reported questions with a qualitative scale and Y/N questions at the end of learning week (week 2) and investigational week (week 3).
Percentage of caregivers selecting a given answer is presented. The scare is 5-point, from minimum 1 to maximum 5 (with 5 being the better outcome).
Number of fecal incidences.
Presented in listing. No formal endpoint. Will only be used for assessing reliable primary endpoint measurements.
Full Information
NCT ID
NCT04846270
First Posted
April 12, 2021
Last Updated
December 16, 2021
Sponsor
Essity Hygiene and Health AB
1. Study Identification
Unique Protocol Identification Number
NCT04846270
Brief Title
Investigation of the Ability of the TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
October 28, 2021 (Actual)
Study Completion Date
October 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Essity Hygiene and Health AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational Device
Arm Type
Experimental
Arm Description
TENA SmartCare Change Indicator
Intervention Type
Device
Intervention Name(s)
TENA SmartCare Change Indicator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the number of manual checks
Description
A comparison between investigational week (week 3) and baseline week (week 1) in the average number of manual checks in-between the daily changes of the absorbing incontinence product.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Incidence of adverse events (AE), adverse device effects (ADE), serious adverse events (SAE), serious adverse device effects (SADE), and device deficiency (DD) during learning week (week 2) and investigational week (week 3).
Description
Number of incidents during the investigation
Time Frame
2 weeks
Title
Change in the number of leakages into the clothes and/or bed linen
Description
A comparison between investigational week (week 3) and baseline week (week 1) in the number of leakages into the clothes and/or bed linen.
Time Frame
3 weeks
Title
Assessment of skin redness and irritation (GLOBIAD scoring)
Description
A comparison between investigational (week 3) week and baseline week (week 1). GlOBIAD is a 4 point scale from minimum 1A to maximum 2B (with 1A being better outcome).
Time Frame
3 weeks
Title
Usability questionnaire: Overall usability assessed via caregiver-reported questions with a qualitative scale and Y/N questions at the end of learning week (week 2) and investigational week (week 3).
Description
Percentage of caregivers selecting a given answer is presented. The scare is 5-point, from minimum 1 to maximum 5 (with 5 being the better outcome).
Time Frame
At the end of learning week (week 2) and investigational week (week 3).
Title
Number of fecal incidences.
Description
Presented in listing. No formal endpoint. Will only be used for assessing reliable primary endpoint measurements.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DEU is diagnosed with urinary incontinence managed with a tape-style incontinence product.
DEU is unable to sufficiently communicate the need for an incontinence product to be changed.
DEU is being cared for in a home environment and most of the care is provided by a main CGR.
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.
CGR is willing and able to provide informed consent to participate in the clinical investigation.
The CGR frequently checks the saturation level of the incontinence product, manually and/or by a touch-feel process.
If incontinence is managed by pharmaceuticals, the dose regime is stable.
DEU and CGR ≥ 18 years of age.
Exclusion Criteria:
DEU is cared for in a professional establishment or is institutionalized.
DEU has ≥ 4 fecal "incidences" per week.
DEU has severe incontinence product related skin problems, as judged by the investigator.
DEU has any type of urinary catheter(s) resulting in improved/treated urinary incontinence.
The incontinence product is changed on a routine based on time (schedule) or device alert, without manual checks.
Any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
CGR is incapable or unwilling to use the required smartphone application and/or the diary registration webpage required for the clinical investigation.
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.
DEU is pregnant or nursing.
CGR or DEU with an alcohol or drug addiction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Piotr Radziszewski, MD, PhD
Organizational Affiliation
Medical Concierge Centrum Medyczne, Polnej Rózy 6/U2, 02-798 Warszawa,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Concierge Centrum Medyczne
City
Warszawa
ZIP/Postal Code
02-798
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigation of the Ability of the TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products
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