Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence

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.

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Device: 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 TENA SmartCare Change Indicator. The collected data will be used to assess the device related algorithms. These algorithms have been established and verified in a laboratory environment. However, due to possible differences in parameters, real-life measurement data are to be collected to aid in further product development.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Tre Stiftelser

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The subject is willing and able to provide informed consent and to participate in the clinical investigation.
2. The subject is ≥18 years of age.
3. The subject is diagnosed with urinary incontinence.
4. The subject is being cared for at Tre Stiftelser.

Exclusion Criteria:

1. The subject has ≥ 4 fecal "incidences" per week.
2. The subject has severe absorbent product related skin problems, as judged by the investigator.
3. The subject is hyper sensitive related to allergic reaction to any of the included materials, as judged by the investigator.
4. The subject has ≥ 2 intermittent urinary catheters per day.
5. The subject has a pacemaker or an implantable cardioverter-defibrillator.
6. The subject removes the incontinence product.
7. The subject demonstrates responsive behavior towards sensors.
8. The subject has any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
9. The subject is not cared for at Tre Stiftelser.
10. The subject is pregnant or lactating.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Investigational Device; TENA SmartCare Change Indicator

Device: TENA SmartCare Change Indicator; Each participating subject will be provided with a Change Indicator and absorbent products for the duration of the investigation. Nine types of absorbent products will be used to collect real-life measurement data in order to assess the mathematical algorithms involved in the TENA SmartCare Change Indicator. Each participating subject will be allocated to the type(s) that are considered most suitable. Gateways will be placed in the resident's rooms as well as in common areas, this to enable full measurement registration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine Volume Quantification and Impedance Measurements	Descriptive statistics were used to summarize any individual differences between the predicted urine volume from the Change Indicator and the true urine volume (by measuring absorbent product weight). A measure of mean difference for the predicted volume minus true volume is assessed. A combination of these values were used to assess the mathematical algorithms for the TENA SmartCare Change Indicator.	11 weeks

Collaborators and Investigators

• Sponsor: Essity Hygiene and Health AB
• Investigators: Principal Investigator: Ulla Molander, MD, PhD, Avd. för Invärtes medicin och klinisk nutrition, Högsbo sjukhus, Göteborg

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 5, 2019
• Primary Completion (ACTUAL): November 27, 2019
• Study Completion (ACTUAL): November 27, 2019

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (ACTUAL): August 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: FUEL_CIP_Ver.B_19-Jul-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No