Urinary Incontinence
Conditions
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.
Interventions
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.
Sponsors
Essity Hygiene and Health AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject is willing and able to provide informed consent and to participate in the clinical investigation. 2. The subject is ≥18 years of age. 3. The subject is diagnosed with urinary incontinence. 4. The subject is being cared for at Tre Stiftelser.
Exclusion criteria
1. The subject has ≥ 4 fecal incidences per week. 2. The subject has severe absorbent product related skin problems, as judged by the investigator. 3. The subject is hyper sensitive related to allergic reaction to any of the included materials, as judged by the investigator. 4. The subject has ≥ 2 intermittent urinary catheters per day. 5. The subject has a pacemaker or an implantable cardioverter-defibrillator. 6. The subject removes the incontinence product. 7. The subject demonstrates responsive behavior towards sensors. 8. The subject has any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator. 9. The subject is not cared for at Tre Stiftelser. 10. The subject is pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine Volume Quantification and Impedance Measurements | 11 weeks | 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. |
Countries
Sweden
Participant flow
Recruitment details
The first subject was enrolled to the investigation on 05 September 2019. The last subject´s last visit was on 27 November 2019.The study was carried out at a nursing home.
Participants by arm
| Arm | Count |
|---|---|
| Investigational Device TENA SmartCare Urine Sensor and Gateway | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Investigational Device | — |
|---|---|---|
| Age, Continuous | 84 years STANDARD_DEVIATION 7 | — |
| Bedridden | 1 Participants | — |
| Childbearing potential of subjects | 0 Participants | — |
| Number of subjects with general health status assessed as fair | 13 Participants | — |
| Prior use of incontinence products | 1 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Sweden | 13 participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 2 / 15 |
Outcome results
Primary
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.
Time frame: 11 weeks
Population: Full Analysis Set (FAS) include data from 13 out of 15 subjects. 684 out of 1180 collected data points were included in the primary endpoint analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational Device | Urine Volume Quantification and Impedance Measurements | 46 ml | Standard Deviation 213 |