Back to resultsCollecting Real-life Data for the Updated TENA SmartCare Change Indicator.
Primary Purpose
Urinary Incontinence
Status
Not yet recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
TENA SmartCare Change Indicator
Sponsored by
About this trial
This is an interventional other trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria: Be willing and able to provide informed consent to participate or, if unable to provide such consent, have a legal representative who is willing and able to provide informed consent on behalf of the resident. Be 18 years of age of older. Be cared for at the investigation site. Suffer from urinary incontinence. Be current user of TENA Slip, Flex, Pants or Comfort incontinence products or during the course of the study be willing to become user of TENA Slip Flex, Pants or Comfort incontinence products. If applicable, be on a stable regimen of medications for urinary incontinence. Exclusion Criteria: Have frequent (daily) faecal incontinence in the pad or having severe problems with faecal incontinence as determined by the investigator. Have severe incontinence product related skin problems, as defined by the GLOBIAD categorization 2B (skin loss & infection). Have any type of indwelling or external urinary catheter(s). Be anuric. Be of childbearing potential as determined by the investigator. Be managed using another automated or digital health technology incontinence management device. Have responsive behaviors of sufficient severity, in the opinion of the care staff, to make participation impractical. Have any other condition that makes participation in the clinical investigation Have a life expectancy of less than 90 days or be in receipt of palliative/terminal care. Have participated in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the clinical investigation. Be dependent on either alcohol or recreational drugs.
Sites / Locations
- Tre Stiftelser Änggårdsbacken
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Subjects wear the sensor part of the Change indicator system during a 15-day period.
Outcomes
Primary Outcome Measures
Urine weight
Absorbing hygiene products used by the subjects are collected in the investigation and the urine weight is determined. The urine weight is then matched with the data measured by the sensor to obtain connect sensor raw data with a specific urine content of an absorbing hygiene products
Secondary Outcome Measures
Number of safety related events
Reported adverse events and device deficiencies are collected during the study.
Caregiver assessment on urine saturation
At the collection of the used absorbing hygiene products the caregiver assess the content of the product and if the change of the product was early, in time or late.
Caregiver usability for sensor
Using a questionnaire at the end of the study data on the caregivers user experience with the sensor is collected using a 5-grade Likert scale were 1 is minimum and 5 maximum and 5 represents the better outcome.
Resident satisfaction with sensor
Using a questionnaire at the end of the study data on the residents satisfaction with the sensor is collected using a 5-grade Likert scale were 1 is minimum and 5 maximum and 5 represents the better outcome.
Full Information
NCT ID
NCT06092099
First Posted
October 13, 2023
Last Updated
October 19, 2023
Sponsor
Essity Hygiene and Health AB
1. Study Identification
Unique Protocol Identification Number
NCT06092099
Brief Title
Collecting Real-life Data for the Updated TENA SmartCare Change Indicator.
Official Title
A Clinical Investigation to Collect Real-life Measurement Data to Allow Development of Mathematical Algorithms for the Updated TENA SmartCare Change Indicator.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 20, 2023 (Anticipated)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
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
This study is an explorative, open, single-arm clinical investigation to collect real-life measurement data in order to assess the mathematical algorithms involved in TENA SmartCare Change Indicator.
Detailed Description
The purpose of this exploratory clinical investigation is to evaluate safety and to collect real-life measurement data using the updated TENA SmartCare Change Indicator. The collected data will be used to assess and develop the device related algorithms. These algorithms have been tested in a laboratory setting but real-life measurement data are to be collected to the aid in further product development.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All subjects in the study will use the device
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Subjects wear the sensor part of the Change indicator system during a 15-day period.
Intervention Type
Device
Intervention Name(s)
TENA SmartCare Change Indicator
Intervention Description
The TENA SmartCare Change Indicator is an accessory to absorbent incontinence products, intended for use on individual(s) with urinary incontinence who are dependent on one or more caregivers to change the absorbent incontinence product. The TENA SmartCare Change Indicator estimates the degree of urine saturation in the absorbent incontinence product and notifies the caregivers. This facilitates the caregiver's decision regarding when to change the absorbent incontinence product. As the current study is needed to validate the updated device, the full system will not be used, only the sensor part.
Primary Outcome Measure Information:
Title
Urine weight
Description
Absorbing hygiene products used by the subjects are collected in the investigation and the urine weight is determined. The urine weight is then matched with the data measured by the sensor to obtain connect sensor raw data with a specific urine content of an absorbing hygiene products
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Number of safety related events
Description
Reported adverse events and device deficiencies are collected during the study.
Time Frame
15 days
Title
Caregiver assessment on urine saturation
Description
At the collection of the used absorbing hygiene products the caregiver assess the content of the product and if the change of the product was early, in time or late.
Time Frame
15 days
Title
Caregiver usability for sensor
Description
Using a questionnaire at the end of the study data on the caregivers user experience with the sensor is collected using a 5-grade Likert scale were 1 is minimum and 5 maximum and 5 represents the better outcome.
Time Frame
15 days
Title
Resident satisfaction with sensor
Description
Using a questionnaire at the end of the study data on the residents satisfaction with the sensor is collected using a 5-grade Likert scale were 1 is minimum and 5 maximum and 5 represents the better outcome.
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be willing and able to provide informed consent to participate or, if unable to provide such consent, have a legal representative who is willing and able to provide informed consent on behalf of the resident.
Be 18 years of age of older.
Be cared for at the investigation site.
Suffer from urinary incontinence.
Be current user of TENA Slip, Flex, Pants or Comfort incontinence products or during the course of the study be willing to become user of TENA Slip Flex, Pants or Comfort incontinence products.
If applicable, be on a stable regimen of medications for urinary incontinence.
Exclusion Criteria:
Have frequent (daily) faecal incontinence in the pad or having severe problems with faecal incontinence as determined by the investigator.
Have severe incontinence product related skin problems, as defined by the GLOBIAD categorization 2B (skin loss & infection).
Have any type of indwelling or external urinary catheter(s).
Be anuric.
Be of childbearing potential as determined by the investigator.
Be managed using another automated or digital health technology incontinence management device.
Have responsive behaviors of sufficient severity, in the opinion of the care staff, to make participation impractical.
Have any other condition that makes participation in the clinical investigation
Have a life expectancy of less than 90 days or be in receipt of palliative/terminal care.
Have participated in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the clinical investigation.
Be dependent on either alcohol or recreational drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fredrik Agholme, PhD
Phone
0730323634
Email
fredrik.agholme@essity.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fana Hunegnaw
Email
Fana.Hunegnaw@essity.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Frösing, MD
Organizational Affiliation
VIP Hälsan Väst
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tre Stiftelser Änggårdsbacken
City
Gothenburg
ZIP/Postal Code
SE-41346
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rasha Riad Sandén
First Name & Middle Initial & Last Name & Degree
Roland Frösing, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Collecting Real-life Data for the Updated TENA SmartCare Change Indicator.
We'll reach out to this number within 24 hrs