Collecting Real-life Data for the Updated TENA SmartCare Change Indicator.

NCT ID: NCT06092099

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-02
• Study Completion Date: 2024-02-28

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention

Subjects wear the sensor part of the Change indicator system during a 15-day period.

Group Type: EXPERIMENTAL

TENA SmartCare Change Indicator

Intervention Type: DEVICE

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.

Interventions

TENA SmartCare Change Indicator

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Essity Hygiene and Health AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roland Frösing, MD

Role: PRINCIPAL_INVESTIGATOR

VIP Hälsan Väst

Locations

Tre Stiftelser Änggårdsbacken

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

GASOLINA

Identifier Type: -

Identifier Source: org_study_id