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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.
The purpose of this exploratory clinical investigation is to evaluate safety and to collect real-life measurement data using the updated TENA SmartCare Change Indicator. The collected data will be used to assess and develop the device related algorithms. These algorithms have been tested in a laboratory setting but real-life measurement data are to be collected to the aid in further product development.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Subjects wear the sensor part of the Change indicator system during a 15-day period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of safety related events | Reported adverse events and device deficiencies are collected during the study. | 15 days |
| Caregiver assessment on urine saturation | At the collection of the used absorbing hygiene products the caregiver assess the urine content of the product. This is done by indicating on a 3-point scale if the product change was 1. early, 2. in time or 3. late. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roland Frösing, MD | VIP Hälsan Väst | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tre Stiftelser Änggårdsbacken | Gothenburg | SE-41346 | Sweden |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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All subjects in the study will use the device
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| 15 days |
| Caregiver usability for sensor | Using a questionnaire at the end of the study data on the caregivers user experience with the sensor is collected using a 5-grade Likert scale were 1 is minimum and 5 maximum and 5 represents the better outcome. | 15 days |
| Resident satisfaction with sensor | Using a questionnaire at the end of the study data on the residents satisfaction with the sensor is collected using a 5-grade Likert scale were 1 is minimum and 5 maximum and 5 represents the better outcome. | 15 days |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |