Urinary Incontinence
Conditions
Brief summary
The purpose of this post market clinical investigation is to demonstrate the performance and safety of the TENA SmartCare Change Indicator.
Detailed description
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.
Interventions
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.
Sponsors
Essity Hygiene and Health AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. DEU is diagnosed with urinary incontinence managed with a tape-style incontinence product. 2. DEU is unable to sufficiently communicate the need for an incontinence product to be changed. 3. DEU is being cared for in a home environment and most of the care is provided by a main CGR. 4. DEU is willing and able to provide informed consent and to participate in the clinical investigation or has a legally designated representative willing to provide informed consent on behalf of the DEU. Note, the legally designated representative and main CGR cannot be the same person. 5. CGR is willing and able to provide informed consent to participate in the clinical investigation. 6. The CGR frequently checks the saturation level of the incontinence product, manually and/or by a touch-feel process. 7. If incontinence is managed by pharmaceuticals, the dose regime is stable. 8. DEU and CGR ≥ 18 years of age.
Exclusion criteria
1. DEU is cared for in a professional establishment or is institutionalized. 2. DEU has ≥ 4 fecal incidences per week. 3. DEU has severe incontinence product related skin problems, as judged by the investigator. 4. DEU has any type of urinary catheter(s) resulting in improved/treated urinary incontinence. 5. The incontinence product is changed on a routine based on time (schedule) or device alert, without manual checks. 6. Any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator. 7. CGR is incapable or unwilling to use the required smart phone application and/or the diary registration webpage required for the clinical investigation. 8. Participation in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the course of the clinical investigation. 9. DEU is pregnant or nursing. 10. CGR or DEU with an alcohol or drug addiction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Manual Checks Per Day at Baseline Week and 3 Weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Safety Related Events | 3 weeks | 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. |
| Number of Leakages Per Day Into the Clothes and/or Bed Linen at Baseline and 3 Weeks | 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). |
| Number of Participants With Skin Redness and Irritation | 3 weeks | 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. |
| Usability Assessed Via Caregiver-reported Questions With a Qualitative Scale at the End of the Study. | At the end of investigational week (week 3). | Average score is presented. The scale is 5-point, from minimum 1 to maximum 5 (with 5 being the better outcome). |
| Number of Fecal Incidences. | 3 weeks | Presented in listing. No formal endpoint. Will only be used for assessing reliable primary endpoint measurements. |
Countries
Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Investigational Device | — |
|---|---|---|
| Age, Continuous | 74 years STANDARD_DEVIATION 23 | — |
| General Cognitive Function Mild cognitive impairment | 26 participants | — |
| General Cognitive Function No cognitive impairment | 5 participants | — |
| General Cognitive Function Severe cognitive impairment | 4 participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Poland | 35 participants | — |
| Sex: Female, Male Female | 28 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 4 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
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).
Time frame: 3 weeks
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Device | Number of Manual Checks Per Day at Baseline Week and 3 Weeks | Investigational week | 3.5 Checks per day | Standard Deviation 2 |
| Investigational Device | Number of Manual Checks Per Day at Baseline Week and 3 Weeks | Baseline week | 4.3 Checks per day | Standard Deviation 1.8 |
Comparison: POWER is a single arm investigation with cross-over design. Each participating subject will use the study device and act as its own control.~The null hypothesis (H0) is that there is no difference in the mean number of checks performed during the investigation week compared to the baseline week.~The alternate hypothesis (H1) is that there is a reduction in the mean number of checks performed during the investigation week compared to the baseline week.p-value: 0.0006Wilcoxon (Mann-Whitney)
Secondary
Number of Fecal Incidences.
Presented in listing. No formal endpoint. Will only be used for assessing reliable primary endpoint measurements.
Time frame: 3 weeks
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Device | Number of Fecal Incidences. | Investigational week | 0.059 Fecal episodes per day | Standard Deviation 0.178 |
| Investigational Device | Number of Fecal Incidences. | Baseline week | 0.066 Fecal episodes per day | Standard Deviation 0.215 |
p-value: 0.76Wilcoxon (Mann-Whitney)
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).
Time frame: 3 weeks
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Device | Number of Leakages Per Day Into the Clothes and/or Bed Linen at Baseline and 3 Weeks | Investigational week | 0.2 Leakages per day | Standard Deviation 0.37 |
| Investigational Device | Number of Leakages Per Day Into the Clothes and/or Bed Linen at Baseline and 3 Weeks | Baseline week | 0.33 Leakages per day | Standard Deviation 0.44 |
p-value: 0.0051Wilcoxon (Mann-Whitney)
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.
Time frame: 3 weeks
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Investigational Device | Number of Participants With Skin Redness and Irritation | Investigational week No visible skin redness or irritation. | 35 Participants |
| Investigational Device | Number of Participants With Skin Redness and Irritation | Investigational week GLOBIAD score 1A | 0 Participants |
| Investigational Device | Number of Participants With Skin Redness and Irritation | Investigational week GLOBIAD score 1B | 0 Participants |
| Investigational Device | Number of Participants With Skin Redness and Irritation | Investigational week GLOBIAD score 2A | 0 Participants |
| Investigational Device | Number of Participants With Skin Redness and Irritation | Investigational week GLOBIAD score 2B | 0 Participants |
| Investigational Device | Number of Participants With Skin Redness and Irritation | Baseline week. GLOBIAD score 1A. | 2 Participants |
| Investigational Device | Number of Participants With Skin Redness and Irritation | Baseline week. No visible skin redness or irritation. | 33 Participants |
| Investigational Device | Number of Participants With Skin Redness and Irritation | Baseline week. GLOBIAD score 1B. | 0 Participants |
| Investigational Device | Number of Participants With Skin Redness and Irritation | Baseline week. GLOBIAD score 2A. | 0 Participants |
| Investigational Device | Number of Participants With Skin Redness and Irritation | Baseline week. GLOBIAD score 2B. | 0 Participants |
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.
Time frame: 3 weeks
Population: The population consist of all consented subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Investigational Device | Number of Safety Related Events | Adverse events | 5 Occurences |
| Investigational Device | Number of Safety Related Events | Adverse device effects | 0 Occurences |
| Investigational Device | Number of Safety Related Events | Serious adverse events | 0 Occurences |
| Investigational Device | Number of Safety Related Events | Serious adverse device effects | 0 Occurences |
| Investigational Device | Number of Safety Related Events | Device deficiency | 39 Occurences |
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).
Time frame: At the end of investigational week (week 3).
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Device | Usability Assessed Via Caregiver-reported Questions With a Qualitative Scale at the End of the Study. | How would you evaluate the written instructions for use of the system? | 4.7 score on a scale | Standard Deviation 0.5 |
| Investigational Device | Usability Assessed Via Caregiver-reported Questions With a Qualitative Scale at the End of the Study. | How easy was the Change Indicator to use? | 4.8 score on a scale | Standard Deviation 0.5 |
| Investigational Device | Usability Assessed Via Caregiver-reported Questions With a Qualitative Scale at the End of the Study. | How easy was the app to use? | 4.9 score on a scale | Standard Deviation 0.3 |
| Investigational Device | Usability Assessed Via Caregiver-reported Questions With a Qualitative Scale at the End of the Study. | How would you grade the overall usefulness of the system? | 4.4 score on a scale | Standard Deviation 0.9 |