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Completed

NCT Number: NCT06092099

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

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tre Stiftelser Änggårdsbacken

Gothenburg, SE-41346, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TENA SmartCare Change Indicator

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.

Primary outcomes

  1. Urine weight

    Time frame: 15 days

    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 outcomes

  1. Number of safety related events

    Time frame: 15 days

    Reported adverse events and device deficiencies are collected during the study.

  2. Caregiver assessment on urine saturation

    Time frame: 15 days

    At the collection of the used absorbing hygiene products the caregiver assess the urine content of the product. This is done by indicating on a 3-point scale if the product change was 1. early, 2. in time or 3. late.

  3. Caregiver usability for sensor

    Time frame: 15 days

    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.

  4. Resident satisfaction with sensor

    Time frame: 15 days

    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.

Sponsors and collaborators

Lead sponsor

Essity Hygiene and Health AB

Industry

Registry information

Official study title

A Clinical Investigation to Collect Real-life Measurement Data to Allow Development of Mathematical Algorithms for the Updated TENA SmartCare Change Indicator.

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Oct 23, 2023
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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