Urinary IncontinenceNCT04071301

Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence

A study testing TENA SmartCare Change Indicator in people with Urinary Incontinence, run by Essity Hygiene and Health AB at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Urinary Incontinence
What is being tested?: TENA SmartCare Change Indicator
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteSweden
Study dates: 5 Sep 2019to 27 Nov 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The subject is willing and able to provide informed consent and to participate in the clinical investigation.
The subject is ≥18 years of age.
The subject is diagnosed with urinary incontinence.
The subject is being cared for at Tre Stiftelser.

Who cannot join

The subject has ≥ 4 fecal "incidences" per week.
The subject has severe absorbent product related skin problems, as judged by the investigator.
The subject is hyper sensitive related to allergic reaction to any of the included materials, as judged by the investigator.
The subject has ≥ 2 intermittent urinary catheters per day.
The subject has a pacemaker or an implantable cardioverter-defibrillator.
The subject removes the incontinence product.

Show all 10Show fewer

The subject demonstrates responsive behavior towards sensors.
The subject has any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
The subject is not cared for at Tre Stiftelser.
The subject is pregnant or lactating.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Tre Stiftelser
Gothenburg

Other trials in Sweden

About this study

Official title: 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.

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.

Read the 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.

Conditions: Urinary Incontinence
Being tested: TENA SmartCare Change Indicator
Medical subject headings: Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TENA SmartCare Change IndicatorDevice
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.

Study groups in NCT04071301
Study group	Role	What they receive
Investigational Device	Experimental	TENA SmartCare Change Indicator Receives: Device: TENA SmartCare Change Indicator

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 11 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Sep 201927 Nov 2019

First posted28 Aug 2019
Study start5 Sep 2019
Primary completion27 Nov 2019
Study completion27 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04071301
Sponsor's protocol ID: FUEL_CIP_Ver.B_19-Jul-2019
Status last verified: May 2021
First submitted: 26 Aug 2019
Last updated: 2 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Urinary Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT04071301
Acronym / sponsor ID: FUEL_CIP_Ver.B_19-Jul-2019
Conditions: Urinary Incontinence
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Essity Hygiene and Health ABIndustry (pharma, biotech, devices)
Study start: 5 Sep 2019 (actual)
Primary completion: 27 Nov 2019 (actual)
Study completion: 27 Nov 2019 (actual)
First posted: 28 Aug 2019 (actual)
Results: Posted 2 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Investigational Device	Experimental	Device: TENA SmartCare Change IndicatorTENA SmartCare Change Indicator

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

The subject is willing and able to provide informed consent and to participate in the clinical investigation.
The subject is ≥18 years of age.
The subject is diagnosed with urinary incontinence.
The subject is being cared for at Tre Stiftelser.

Key exclusion criteria (10 listed)

The subject has ≥ 4 fecal "incidences" per week.
The subject has severe absorbent product related skin problems, as judged by the investigator.
The subject is hyper sensitive related to allergic reaction to any of the included materials, as judged by the investigator.
The subject has ≥ 2 intermittent urinary catheters per day.
The subject has a pacemaker or an implantable cardioverter-defibrillator.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TENA SmartCare Change IndicatorEach 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.	Device	Investigational Device

Primary outcome

Urine Volume Quantification and Impedance Measurements
Time frame: 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.

Results and safety

Results posted to the registry on 2 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Investigational Device	15	8

Primary outcome: Urine Volume Quantification and Impedance Measurements

Time frame: 11 weeks. Mean (Standard Deviation). Unit: ml

Measure	Investigational Device n = 13
Value	46 (213)

Population analysed: 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.

Adverse events

Time frame: 11 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigational Device	2 of 15 (13.3%)	0 of 15 (0%)	1 of 15

Limitations and caveats (from the sponsor): Only the Change indicator and Gateway were used, i.e. the smart phone app was not part of the investigation why the clinical benefit relating to app notifications was not investigated. There was a drop off in eligible data points compared to the total number of data points. The reason to this was device deficiencies on some sensors leading to erroneous raw data. The deficiencies were anticipated as the sensors being pre-production devices. 2/3 of the data points were used for evaluation.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Urinary Incontinence

Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ulla Molander, MD, PhD principal investigator

Avd. för Invärtes medicin och klinisk nutrition, Högsbo sjukhus, Göteborg

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TENA SmartCare Change Indicator in people with Urinary Incontinence, run by Essity Hygiene and Health AB at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urine Volume Quantification and Impedance Measurements (time frame: 11 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04071301.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.