Back to resultsCollection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
TENA SmartCare Change Indicator
Sponsored by
About this trial
This is an interventional device feasibility trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- The subject is willing and able to provide informed consent and to participate in the clinical investigation.
- The subject is ≥18 years of age.
- The subject is diagnosed with urinary incontinence.
- The subject is being cared for at Tre Stiftelser.
Exclusion Criteria:
- The subject has ≥ 4 fecal "incidences" per week.
- The subject has severe absorbent product related skin problems, as judged by the investigator.
- The subject is hyper sensitive related to allergic reaction to any of the included materials, as judged by the investigator.
- The subject has ≥ 2 intermittent urinary catheters per day.
- The subject has a pacemaker or an implantable cardioverter-defibrillator.
- The subject removes the incontinence product.
- The subject demonstrates responsive behavior towards sensors.
- The subject has any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
- The subject is not cared for at Tre Stiftelser.
- The subject is pregnant or lactating.
Sites / Locations
- Tre Stiftelser
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Investigational Device
Arm Description
TENA SmartCare Change Indicator
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04071301
First Posted
August 26, 2019
Last Updated
May 31, 2021
Sponsor
Essity Hygiene and Health AB
1. Study Identification
Unique Protocol Identification Number
NCT04071301
Brief Title
Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 5, 2019 (Actual)
Primary Completion Date
November 27, 2019 (Actual)
Study Completion Date
November 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Essity Hygiene and Health AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational Device
Arm Type
Experimental
Arm Description
TENA SmartCare Change Indicator
Intervention Type
Device
Intervention Name(s)
TENA SmartCare Change Indicator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Urine Volume Quantification and Impedance Measurements
Description
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.
Time Frame
11 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject is willing and able to provide informed consent and to participate in the clinical investigation.
The subject is ≥18 years of age.
The subject is diagnosed with urinary incontinence.
The subject is being cared for at Tre Stiftelser.
Exclusion Criteria:
The subject has ≥ 4 fecal "incidences" per week.
The subject has severe absorbent product related skin problems, as judged by the investigator.
The subject is hyper sensitive related to allergic reaction to any of the included materials, as judged by the investigator.
The subject has ≥ 2 intermittent urinary catheters per day.
The subject has a pacemaker or an implantable cardioverter-defibrillator.
The subject removes the incontinence product.
The subject demonstrates responsive behavior towards sensors.
The subject has any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
The subject is not cared for at Tre Stiftelser.
The subject is pregnant or lactating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulla Molander, MD, PhD
Organizational Affiliation
Avd. för Invärtes medicin och klinisk nutrition, Högsbo sjukhus, Göteborg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tre Stiftelser
City
Gothenburg
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence
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