Urinary IncontinenceNCT04846270
Investigation of the Ability of the TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products
A study testing TENA SmartCare Change Indicator in people with Urinary Incontinence, run by Essity Hygiene and Health AB at 1 site in Poland.
Trial summary
The purpose of this post market clinical investigation is to demonstrate the performance and safety of the 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
- 35 participants
- Where
- 1 sitePoland
- Study dates
- 14 Apr 2021to 28 Oct 2021
- 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
- DEU is diagnosed with urinary incontinence managed with a tape-style incontinence product.
- DEU is unable to sufficiently communicate the need for an incontinence product to be changed.
- DEU is being cared for in a home environment and most of the care is provided by a main CGR.
- 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.
- CGR is willing and able to provide informed consent to participate in the clinical investigation.
- The CGR frequently checks the saturation level of the incontinence product, manually and/or by a touch-feel process.
- If incontinence is managed by pharmaceuticals, the dose regime is stable.
- DEU and CGR ≥ 18 years of age.
Who cannot join
- DEU is cared for in a professional establishment or is institutionalized.
- DEU has ≥ 4 fecal "incidences" per week.
- DEU has severe incontinence product related skin problems, as judged by the investigator.
- DEU has any type of urinary catheter(s) resulting in improved/treated urinary incontinence.
- The incontinence product is changed on a routine based on time (schedule) or device alert, without manual checks.
- Any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
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- CGR is incapable or unwilling to use the required smart phone application and/or the diary registration webpage required for the clinical investigation.
- 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.
- DEU is pregnant or nursing.
- CGR or DEU with an alcohol or drug addiction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Single-arm, Post-market Clinical Investigation to Verify the Ability of TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products in a Home Environment.
The purpose of this post market clinical investigation is to demonstrate the performance and safety of the TENA SmartCare Change Indicator.
Read the 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.
- 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 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.
| 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.
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).
Measured: 3 weeks
Secondary outcomes (5)
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.
Measured: 3 weeks
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).
Measured: 3 weeks
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.
Measured: 3 weeks
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).
Measured: At the end of investigational week (week 3).
Number of Fecal Incidences.
Presented in listing. No formal endpoint. Will only be used for assessing reliable primary endpoint measurements.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start14 Apr 2021
- Primary completion28 Oct 2021
- Study completion28 Oct 2021
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essity Hygiene and Health AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Piotr Radziszewski, MD, PhD, Principal investigator, Medical Concierge Centrum Medyczne, Polnej Rózy 6/U2, 02-798 Warszawa,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846270
- Sponsor's protocol ID
- POWER
- Status last verified
- Oct 2023
- First submitted
- 12 Apr 2021
- Last updated
- 8 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-arm, Post-market Clinical Investigation to Verify the Ability of TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products in a Home Environment.
- ClinicalTrials.gov ID
- NCT04846270
- Acronym / sponsor ID
- POWER
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Essity Hygiene and Health ABIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Posted 8 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- 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 (8 listed)
- DEU is diagnosed with urinary incontinence managed with a tape-style incontinence product.
- DEU is unable to sufficiently communicate the need for an incontinence product to be changed.
- DEU is being cared for in a home environment and most of the care is provided by a main CGR.
- 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.
- CGR is willing and able to provide informed consent to participate in the clinical investigation.
Key exclusion criteria (10 listed)
- DEU is cared for in a professional establishment or is institutionalized.
- DEU has ≥ 4 fecal "incidences" per week.
- DEU has severe incontinence product related skin problems, as judged by the investigator.
- DEU has any type of urinary catheter(s) resulting in improved/treated urinary incontinence.
- The incontinence product is changed on a routine based on time (schedule) or device alert, without manual checks.
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 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. | Device | Investigational Device |
Primary outcome
Number of Manual Checks Per Day at Baseline Week and 3 Weeks
Time frame: 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).
5 secondary outcomes
Number of Safety Related Events
Time frame: 3 weeks
Number of Leakages Per Day Into the Clothes and/or Bed Linen at Baseline and 3 Weeks
Time frame: 3 weeks
Number of Participants With Skin Redness and Irritation
Time frame: 3 weeks
Usability Assessed Via Caregiver-reported Questions With a Qualitative Scale at the End of the Study.
Time frame: At the end of investigational week (week 3).
Number of Fecal Incidences.
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Prof. Piotr Radziszewski, MD, PhD principal investigator
Medical Concierge Centrum Medyczne, Polnej Rózy 6/U2, 02-798 Warszawa,
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 Poland.
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 8 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 8 Apr 2024. 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 Poland. 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 8 Apr 2024). 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?
Number of Manual Checks Per Day at Baseline Week and 3 Weeks (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2024.