Status:
COMPLETED
Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence
Lead Sponsor:
Essity Hygiene and Health AB
Conditions:
Urinary Incontinence
Eligibility:
All Genders
18+ years
Phase:
NA
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 ass...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04071301
Start Date
September 5 2019
End Date
November 27 2019
Last Update
June 2 2021
Active Locations (1)
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1
Tre Stiftelser
Gothenburg, Sweden