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

NCT06092099 | Completed

• 1 other identifier: GASOLINA
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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

  15 days

Secondary Outcomes (4)

• Number of safety related events

  15 days

• Caregiver assessment on urine saturation

  15 days

• Caregiver usability for sensor

  15 days

• Resident satisfaction with sensor

  15 days

Study Arms (1)

Intervention

EXPERIMENTAL

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

Device: TENA SmartCare Change Indicator

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Essity Hygiene and Health AB: lead

Study Sites (1)

Tre Stiftelser Änggårdsbacken

Gothenburg, SE-41346, Sweden

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

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

Study Officials

• Roland Frösing, MD

  VIP Hälsan Väst

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects in the study will use the device

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 23, 2023
• Study Start: November 2, 2023
• Primary Completion: December 21, 2023
• Study Completion: February 28, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)