Trial Outcomes & Findings for Investigation of the Ability of the TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products (NCT NCT04846270)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

3 weeks

Results posted on

2024-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational Device n=35 Participants 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.
Age, Continuous	74 years STANDARD_DEVIATION 23 • n=35 Participants
Sex: Female, Male Female	28 Participants n=35 Participants
Sex: Female, Male Male	7 Participants n=35 Participants
Region of Enrollment Poland	35 participants n=35 Participants
General Cognitive Function No cognitive impairment	5 participants n=35 Participants
General Cognitive Function Mild cognitive impairment	26 participants n=35 Participants
General Cognitive Function Severe cognitive impairment	4 participants n=35 Participants

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	Investigational Device n=35 Participants 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.
Number of Manual Checks Per Day at Baseline Week and 3 Weeks Investigational week	3.5 Checks per day Standard Deviation 2.0
Number of Manual Checks Per Day at Baseline Week and 3 Weeks Baseline week	4.3 Checks per day Standard Deviation 1.8

SECONDARY outcome

Timeframe: 3 weeks

Population: The population consist of all consented subjects.

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.

Outcome measures

Outcome measures
Measure	Investigational Device n=35 Participants 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.
Number of Safety Related Events Adverse events	5 Occurences
Number of Safety Related Events Adverse device effects	0 Occurences
Number of Safety Related Events Serious adverse events	0 Occurences
Number of Safety Related Events Serious adverse device effects	0 Occurences
Number of Safety Related Events Device deficiency	39 Occurences

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	Investigational Device n=35 Participants 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.
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
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

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Investigational Device n=35 Participants 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.
Number of Participants With Skin Redness and Irritation Baseline week. GLOBIAD score 2B.	0 Participants
Number of Participants With Skin Redness and Irritation Investigational week No visible skin redness or irritation.	35 Participants
Number of Participants With Skin Redness and Irritation Investigational week GLOBIAD score 1A	0 Participants
Number of Participants With Skin Redness and Irritation Investigational week GLOBIAD score 1B	0 Participants
Number of Participants With Skin Redness and Irritation Investigational week GLOBIAD score 2A	0 Participants
Number of Participants With Skin Redness and Irritation Investigational week GLOBIAD score 2B	0 Participants
Number of Participants With Skin Redness and Irritation Baseline week. GLOBIAD score 1A.	2 Participants
Number of Participants With Skin Redness and Irritation Baseline week. No visible skin redness or irritation.	33 Participants
Number of Participants With Skin Redness and Irritation Baseline week. GLOBIAD score 1B.	0 Participants
Number of Participants With Skin Redness and Irritation Baseline week. GLOBIAD score 2A.	0 Participants

SECONDARY outcome

Timeframe: 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.

Average score is presented. The scale is 5-point, from minimum 1 to maximum 5 (with 5 being the better outcome).

Outcome measures

Outcome measures
Measure	Investigational Device n=35 Participants 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.
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
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
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
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

SECONDARY outcome

Timeframe: 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

Presented in listing. No formal endpoint. Will only be used for assessing reliable primary endpoint measurements.

Outcome measures

Outcome measures
Measure	Investigational Device n=35 Participants 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.
Number of Fecal Incidences. Investigational week	0.059 Fecal episodes per day Standard Deviation 0.178
Number of Fecal Incidences. Baseline week	0.066 Fecal episodes per day Standard Deviation 0.215

Adverse Events

Investigational Device

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Investigational Device n=35 participants at risk 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.
Infections and infestations Diarrhea	2.9% 1/35 • Number of events 2 • 3 weeks
General disorders Urinary bleeding	2.9% 1/35 • Number of events 1 • 3 weeks
Infections and infestations Pneumonia	2.9% 1/35 • Number of events 1 • 3 weeks
General disorders Slightly raised temperature	2.9% 1/35 • Number of events 1 • 3 weeks

Additional Information

Fredrik Agholme

Essity Hygiene and Health AB

Phone: +4670323634

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place