Trial Outcomes & Findings for Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence (NCT NCT04071301)

Last Updated: 2021-06-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

11 weeks

Results posted on

2021-06-02

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Investigational Device TENA SmartCare Urine Sensor and Gateway Each participating subject was provided with Urine Sensor and absorbent products for the duration of the investigation. Seven types of absorbent products were used to collect real-life measurement data in order to assess the mathematical algorithms involved in the TENA SmartCare Change Indicator. Each participating subject was allocated to the type(s) that were considered most suitable. Gateways were placed in the resident's rooms as well as in common areas to enable full measurement registration.
Overall Study STARTED	15
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Investigational Device TENA SmartCare Urine Sensor and Gateway Each participating subject was provided with Urine Sensor and absorbent products for the duration of the investigation. Seven types of absorbent products were used to collect real-life measurement data in order to assess the mathematical algorithms involved in the TENA SmartCare Change Indicator. Each participating subject was allocated to the type(s) that were considered most suitable. Gateways were placed in the resident's rooms as well as in common areas to enable full measurement registration.
Overall Study Withdrawal by Subject	6
Overall Study Death	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational Device n=13 Participants TENA SmartCare Urine Sensor and Gateway
Age, Continuous	84 years STANDARD_DEVIATION 7 • n=13 Participants
Sex: Female, Male Female	7 Participants n=13 Participants
Sex: Female, Male Male	6 Participants n=13 Participants
Region of Enrollment Sweden	13 participants n=13 Participants
Bedridden	1 Participants n=13 Participants
Childbearing potential of subjects	0 Participants n=13 Participants
Number of subjects with general health status assessed as fair	13 Participants n=13 Participants
Prior use of incontinence products	1 Participants n=13 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Investigational Device n=13 Participants TENA SmartCare Urine Sensor and Gateway
Urine Volume Quantification and Impedance Measurements	46 ml Standard Deviation 213

Adverse Events

Investigational Device

Serious events: 2 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Investigational Device n=15 participants at risk TENA SmartCare Urine Sensor and Gateway .
Respiratory, thoracic and mediastinal disorders Choke	6.7% 1/15 • Number of events 1 • 11 weeks
Vascular disorders Stroke	6.7% 1/15 • Number of events 1 • 11 weeks

Other adverse events

Adverse event data not reported

Additional Information

Fredrik Agholme, Clinical Trials Manager, Clinical Affairs

Essity Hygiene and Health

Phone: +46 73 0323634

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place