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

Urinary Incontinence Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04071301
• Other study ID #: FUEL_CIP_Ver.B_19-Jul-2019
• Status: Completed
• Phase: N/A
• Start date: September 5, 2019
• Est. completion date: November 27, 2019

Study information

• Verified date: May 2021
• Source: Essity Hygiene and Health AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 27, 2019
• Est. primary completion date: November 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

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.

Locations

Country	Name	City	State
Sweden	Tre Stiftelser	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Essity Hygiene and Health AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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