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The purpose of this post market clinical investigation is to demonstrate the performance and safety of the TENA SmartCare Change Indicator.
The TENA SmartCare Change Indicator is intended for use on individuals, dependent end user (DEU), suffering from Urinary Incontinence (UI) who are cared for in a home environment, by one or more caregivers (CGR). The TENA SmartCare Change Indicator is an accessory to TENA absorbing incontinence products. This clinical investigation is intended to demonstrate that use of TENA SmartCare Change Indicator has the ability to reduce the number of manual checks between daily changes of absorbing incontinence products. Secondarily, the investigation will evaluate number of leakages, skin redness, usability and fecal incidence. Furthermore, the safety will continuously be monitored through analyzing device-related adverse events reported during the investigation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Device | Experimental | TENA SmartCare Change Indicator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENA SmartCare Change Indicator | Device | Each participating subject will be provided with TENA SmartCare Change Indicator and incontinence products for the duration of the investigation. Each participating subject will be allocated to the incontinence type(s) that are considered most suitable. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Manual Checks Per Day at Baseline Week and 3 Weeks | A comparison between the average number of manual checks, in-between the regular changes of the absorbing incontinence product, in the third week of the study (investigational week) and the first week of the study (baseline week). | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Safety Related Events | Reported number of adverse events (AE), adverse device effects (ADE), serious adverse events (SAE), serious adverse device effects (SADE), and device deficiency (DD) as reported in the investigation. | 3 weeks |
| Number of Leakages Per Day Into the Clothes and/or Bed Linen at Baseline and 3 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Piotr Radziszewski, MD, PhD | Medical Concierge Centrum Medyczne, Polnej Rózy 6/U2, 02-798 Warszawa, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Concierge Centrum Medyczne | Warsaw | 02-798 | Poland |
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Device | TENA SmartCare Change Indicator TENA SmartCare Change Indicator: Each participating subject will be provided with TENA SmartCare Change Indicator and incontinence products for the duration of the investigation. Each participating subject will be allocated to the incontinence type(s) that are considered most suitable. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 7, 2020 | Sep 23, 2022 |
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A comparison between the average number of urine leakages (out of the absorbing incontinence product), onto the clothes and/or bed linen, in the third week of the study (investigational week) and the first week of the study (baseline week). |
| 3 weeks |
| Number of Participants With Skin Redness and Irritation | A comparison between investigational (week 3) week and baseline week (week 1). The Ghent Global IAD Categorisation Tool (GlOBIAD) was used. It has a 4 point scale from minimum 1A to maximum 2B (with 1A being better outcome). In the measure. IAD is incontinence associated dermatitis. | 3 weeks |
| Usability Assessed Via Caregiver-reported Questions With a Qualitative Scale at the End of the Study. | Average score is presented. The scale is 5-point, from minimum 1 to maximum 5 (with 5 being the better outcome). | At the end of investigational week (week 3). |
| Number of Fecal Incidences. | Presented in listing. No formal endpoint. Will only be used for assessing reliable primary endpoint measurements. | 3 weeks |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Investigational Device | TENA SmartCare Change Indicator TENA SmartCare Change Indicator: Each participating subject will be provided with TENA SmartCare Change Indicator and incontinence products for the duration of the investigation. Each participating subject will be allocated to the incontinence type(s) that are considered most suitable. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| General Cognitive Function | The principal investigator general assessment of the cognitive function of the participant i.e if there are any confusion or dementia present. | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Manual Checks Per Day at Baseline Week and 3 Weeks | A comparison between the average number of manual checks, in-between the regular changes of the absorbing incontinence product, in the third week of the study (investigational week) and the first week of the study (baseline week). | The population consist of all consented subjects that do not have a major protocol deviation and have at least one set of efficacy measurements after using the investigational device | Posted | Mean | Standard Deviation | Checks per day | 3 weeks |
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| Secondary | Number of Safety Related Events | Reported number of adverse events (AE), adverse device effects (ADE), serious adverse events (SAE), serious adverse device effects (SADE), and device deficiency (DD) as reported in the investigation. | The population consist of all consented subjects. | Posted | Number | Occurences | 3 weeks |
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| Secondary | Number of Leakages Per Day Into the Clothes and/or Bed Linen at Baseline and 3 Weeks | A comparison between the average number of urine leakages (out of the absorbing incontinence product), onto the clothes and/or bed linen, in the third week of the study (investigational week) and the first week of the study (baseline week). | The population consist of all consented subjects that do not have a major protocol deviation and have at least one set of efficacy measurements after using the investigational device | Posted | Mean | Standard Deviation | Leakages per day | 3 weeks |
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| Secondary | Number of Participants With Skin Redness and Irritation | A comparison between investigational (week 3) week and baseline week (week 1). The Ghent Global IAD Categorisation Tool (GlOBIAD) was used. It has a 4 point scale from minimum 1A to maximum 2B (with 1A being better outcome). In the measure. IAD is incontinence associated dermatitis. | The population consist of all consented subjects that do not have a major protocol deviation and have at least one set of efficacy measurements after using the investigational device | Posted | Count of Participants | Participants | 3 weeks |
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| Secondary | Usability Assessed Via Caregiver-reported Questions With a Qualitative Scale at the End of the Study. | Average score is presented. The scale is 5-point, from minimum 1 to maximum 5 (with 5 being the better outcome). | The population consist of all consented subjects that do not have a major protocol deviation and have at least one set of efficacy measurements after using the investigational device. For the questionnaire these questions were answered by the care giving relative. | Posted | Mean | Standard Deviation | score on a scale | At the end of investigational week (week 3). |
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| Secondary | Number of Fecal Incidences. | Presented in listing. No formal endpoint. Will only be used for assessing reliable primary endpoint measurements. | The population consist of all consented subjects that do not have a major protocol deviation and have at least one set of efficacy measurements after using the investigational device | Posted | Mean | Standard Deviation | Fecal episodes per day | 3 weeks |
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3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Investigational Device | TENA SmartCare Change Indicator TENA SmartCare Change Indicator: Each participating subject will be provided with TENA SmartCare Change Indicator and incontinence products for the duration of the investigation. Each participating subject will be allocated to the incontinence type(s) that are considered most suitable. | 0 | 35 | 0 | 35 | 4 | 35 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Infections and infestations | Non-systematic Assessment |
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| Urinary bleeding | General disorders | Non-systematic Assessment | Blood in urine with visible blood clots |
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| Pneumonia | Infections and infestations | Non-systematic Assessment |
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| Slightly raised temperature | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fredrik Agholme | Essity Hygiene and Health AB | +4670323634 | fredrik.agholme@essity.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 25, 2021 | Sep 23, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| 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 |
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| Mild cognitive impairment |
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| Severe cognitive impairment |
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