Urinary IncontinenceNCT06091111
A Clinical Trial to Evaluate Leakage Performance in a Hybrid Absorbing Incontinence Product
A study testing THD, THN in people with Urinary Incontinence, run by Essity Hygiene and Health AB at 1 site in United Kingdom.
Trial summary
The study is prospective, sequential, single group, and interventional but not invasive. The primary objective is to evaluate the leakage performance of the investigational medical devices (absorbing hygiene products, AHPs) compared to reference AHPs currently being used by the subjects. 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?
- THD, THN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Nov 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Have urinary incontinence managed with size M or L (96 -116 cm hip range) TENA Slip and/or TENA Comfort with absorption level plus, super or maxi.
- Be willing and able to provide informed consent and to participate in the clinical investigation.
- Be a permanent (intended length of stay longer than 3 months) resident of the care home.
- Have a stable dose regime if the incontinence is managed by pharmaceuticals.
- Be over 18 years of age.
- Not be of child-bearing potential.
Who cannot join
- Being cared for at home or outside of professional care environment.
- Goes to the toilet to urinate regularly.
- Have severe incontinence product related skin problems, as judged by the investigator.
- Have any type of urinary catheter(s) resulting in improved/treated urinary incontinence.
- Suffering from fecal incontinence with a severity that makes participation in the clinical investigation inappropriate, as judged by investigator.
- Suffer from severe dementia that makes participation in the clinical investigation inappropriate, as judged by investigator.
Show all 10Show fewer
- Having any other condition or recent surgery that may make participation in the clinical investigation inappropriate, as judged by investigator.
- Frequently removes the incontinence product by themselves.
- Have participated in an investigational study of a drug, biologic, or medical device within 30 days prior to entering the clinical investigation or planned during the clinical investigation.
- Having an alcohol or drug addiction.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Lincolnshire Community Health Services NHS Trust
Lincoln, LN5 7JH
About this study
The study is prospective, sequential, single group, and interventional but not invasive. The primary objective is to evaluate the leakage performance of the investigational medical devices (absorbing hygiene products, AHPs) compared to reference AHPs currently being used by the subjects. The study is cross-over and subjects will act as their own control, using their regular device during a 10-day period and comparing this to use of investigational device for 10 days with an initial 3-5 day transition period. In total the subjects participate in the study for about 30 days. The sequence of device use is randomized. The target population are subjects who are suffering from urinary incontinence and are current users of AHPs to manage the incontinence. Subjects are care dependent and being cared for in a care home. The study is conducted at multiple care homes in the United Kingdom. The investigational device is a new type of AHP developed to be more sustainable with a disposable insert placed into a reusable pant. The leakage performance will be tracked by collecting used AHPs and assess the occurrence of leakages and urine content. The number of leakages during the intervention period will be compared to that of the reference period. As secondary outcomes safety, changes in skin condition and caregiver and subject product satisfaction is assessed. In total 42 subjects are planned for the study.
Read the detailed description
This is a pre-market feasibility clinical investigation designed to evaluate the clinical performance and safety of the investigational product in its intended target population.
The clinical investigation is designed according to the ISO 14155:2020 to be prospective, interventional but non-invasive, at multiple care homes and randomised.
There is one group using two different reference products (TENA Comfort or TENA Slip) Cross-over with randomised sequential product use. Use of reference product (TENA comfort or TENA Slip) and investigational product (THD and THN) use.
Residents uses regular (reference) product for 10 days and then switch to the investigational product and use it for 10 days. There will be a 3-5-day transition period when the investigational product is introduced and then follows the 10-day evaluation period.
The investigational and the reference products for this study are absorbing hygiene products (class I medical devices) used as urine incontinence aids. Investigational devices (products) are new specifications THD and THN. THD and THN are hybrid products, consisting of a single use insert and a reusable pant, developed to be more sustainable than the current products in the market. Reference products are current all-in-one and/or two-piece product on the market TENA Slip/Comfort with super, plus and maxi absorption level and sizes M and L.
Primary objective: To evaluate the leakage performance of the investigational products compared to reference products.
Secondary objective(s):
To evaluate safety through analysing product-related adverse events reported during the investigation.
To evaluate any changes in skin condition of the resident during the course of the investigation.
To evaluate caregiver and subject, satisfaction, perception of and experience in using the products related to comfort, softness, dryness, skin health and ease of product washing.
In the study, the products are used by individuals, residents, suffering from incontinence who are cared for in a care home, by one or more professional caregivers.
Multiple care homes within Lincolnshire in the United Kingdom. Lincolnshire Community Health Services National Health Services Trust acts as site and coordinates the care homes. Care homes will be randomised to either start with reference product or investigational product.
A total of 42 subjects is to be included.
For the residents there will be 5 visits:
Visit 1 Screening and recruitment. Visit 2 Period 1 start (Day 0). Visit 3 Transition period start (Day 10+3). Visit 4 Start of period 2 (3-5 days after visit 3). Visit 5 Study completion (Day 10+3 after visit 4).
Between visit 2 and 5 there will be a daily collection by the study team of labelled bags containing used products. These products will then be weighed, labels retrieved, and photos taken.
A descriptive analysis will be carried out for all variables and endpoints. For the analysis each tested product is classified according to presence of leakage (Yes/No). The proportion of products that do not leak is designated the success rate (SR). A non-inferiority one-sided paired t-test will be performed to analyse the primary endpoint.
For the safety endpoint, data on incidence and severity of adverse events related to products will be summarized.
The error rate is set to 2.5% for the primary endpoint and 5% for secondary endpoints.
- Conditions
- Urinary Incontinence
- Being tested
- THD, THN
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THD, THNDevice
New hybrid absorbing incontinence product for day (THD) and night (THN) use. These are variants of the same product. The intervention product is a novel design that contains reusable elements allowing for a more sustainable product.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Subjects is randomized to start with either a period of reference product use followed by a cross over to using the study device or the opposite sequence, starting with the study device and then cross over to using the reference device. Receives: Device: THD, THN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in absorbing product leakage rate
For each resident a success rate (SR, number of products that do not have a urine leakage outside of the product) is calculated and compared between the baseline (standard of care) and the intervention (study device).
Measured: 20 days
Secondary outcomes (3)
Safety data
Incidence of adverse events (AE), adverse product effects (ADE), serious adverse events (SAE), serious adverse device effects (SADE), and device deficiency (DD).
Measured: 20 days
Skin health assessment scoring.
The skin health is followed via a scoring for incontinence associated dermatitis (IAD). The scoring between baseline and intervention are compared. The scoring is on 1-5 scale for grading the skin injury were 1 is no skin irritation and 5 severe skin irritation with infection. Also there is an overall skin problem scoring on a 1-5 scale were 1 is none and 5 is very severe.
Measured: 20 days
Caregiver and resident scoring perception of the investigational product compared to the reference product.
Questionnaire with question regarding the perception and satisfaction of the investigational device regarding some specific aspects like comfort, ease of use and feeling on the skin. The scoring is made for each aspect based on a 1-5 Likert scale were 5 represents the highest value.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start6 Nov 2023
- Primary completion30 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group cross over. Study subjects are randomized to sequence of device use. To either start with reference of study device.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essity Hygiene and Health AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lincolnshire Community Health Services NHS Trust
- Responsible party
- Sponsor
- Investigators
- Janice Weisman, Principal investigator, Lincolnshire Community Health Services NHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091111
- Sponsor's protocol ID
- HEAT
- Status last verified
- Sep 2024
- First submitted
- 12 Oct 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate Leakage Performance in a Hybrid Absorbing Incontinence Product
- ClinicalTrials.gov ID
- NCT06091111
- Acronym / sponsor ID
- HEAT
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Essity Hygiene and Health ABIndustry (pharma, biotech, devices)
- Collaborators
- Lincolnshire Community Health Services NHS Trust
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is prospective, sequential, single group, and interventional but not invasive. The primary objective is to evaluate the leakage performance of the investigational medical devices (absorbing hygiene products, AHPs) compared to reference AHPs currently being used by the subjects. The study is cross-over and subjects will act as their own control, using their regular device during a 10-day period and comparing this to use of investigational device for 10 days with an initial 3-5 day transition period. In total the subjects participate in the study for about 30 days. The sequence of device use is randomized. The target population are subjects who are suffering from urinary incontinence and are current users of AHPs to manage the incontinence. Subjects are care dependent and being cared for in a care home. The study is conducted at multiple care homes in the United Kingdom. The investigational device is a new type of AHP developed to be more sustainable with a disposable insert placed into a reusable pant. The leakage performance will be tracked by collecting used AHPs and assess the occurrence of leakages and urine content. The number of leakages during the intervention period will be compared to that of the reference period. As secondary outcomes safety, changes in skin condition and caregiver and subject product satisfaction is assessed. In total 42 subjects are planned for the study.
Detailed description
This is a pre-market feasibility clinical investigation designed to evaluate the clinical performance and safety of the investigational product in its intended target population.
The clinical investigation is designed according to the ISO 14155:2020 to be prospective, interventional but non-invasive, at multiple care homes and randomised.
There is one group using two different reference products (TENA Comfort or TENA Slip) Cross-over with randomised sequential product use. Use of reference product (TENA comfort or TENA Slip) and investigational product (THD and THN) use.
Residents uses regular (reference) product for 10 days and then switch to the investigational product and use it for 10 days. There will be a 3-5-day transition period when the investigational product is introduced and then follows the 10-day evaluation period.
The investigational and the reference products for this study are absorbing hygiene products (class I medical devices) used as urine incontinence aids. Investigational devices (products) are new specifications THD and THN. THD and THN are hybrid products, consisting of a single use insert and a reusable pant, developed to be more sustainable than the current products in the market. Reference products are current all-in-one and/or two-piece product on the market TENA Slip/Comfort with super, plus and maxi absorption level and sizes M and L.
Primary objective: To evaluate the leakage performance of the investigational products compared to reference products.
Secondary objective(s):
To evaluate safety through analysing product-related adverse events reported during the investigation.
To evaluate any changes in skin condition of the resident during the course of the investigation.
To evaluate caregiver and subject, satisfaction, perception of and experience in using the products related to comfort, softness, dryness, skin health and ease of product washing.
In the study, the products are used by individuals, residents, suffering from incontinence who are cared for in a care home, by one or more professional caregivers.
Multiple care homes within Lincolnshire in the United Kingdom. Lincolnshire Community Health Services National Health Services Trust acts as site and coordinates the care homes. Care homes will be randomised to either start with reference product or investigational product.
A total of 42 subjects is to be included.
For the residents there will be 5 visits:
Visit 1 Screening and recruitment. Visit 2 Period 1 start (Day 0). Visit 3 Transition period start (Day 10+3). Visit 4 Start of period 2 (3-5 days after visit 3). Visit 5 Study completion (Day 10+3 after visit 4).
Between visit 2 and 5 there will be a daily collection by the study team of labelled bags containing used products. These products will then be weighed, labels retrieved, and photos taken.
A descriptive analysis will be carried out for all variables and endpoints. For the analysis each tested product is classified according to presence of leakage (Yes/No). The proportion of products that do not leak is designated the success rate (SR). A non-inferiority one-sided paired t-test will be performed to analyse the primary endpoint.
For the safety endpoint, data on incidence and severity of adverse events related to products will be summarized.
The error rate is set to 2.5% for the primary endpoint and 5% for secondary endpoints.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group cross over. Study subjects are randomized to sequence of device use. To either start with reference of study device.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: THD, THNSubjects is randomized to start with either a period of reference product use followed by a cross over to using the study device or the opposite sequence, starting with the study device and then cross over to using the reference device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have urinary incontinence managed with size M or L (96 -116 cm hip range) TENA Slip and/or TENA Comfort with absorption level plus, super or maxi.
- Be willing and able to provide informed consent and to participate in the clinical investigation.
- Be a permanent (intended length of stay longer than 3 months) resident of the care home.
- Have a stable dose regime if the incontinence is managed by pharmaceuticals.
- Be over 18 years of age.
Key exclusion criteria (10 listed)
- Being cared for at home or outside of professional care environment.
- Goes to the toilet to urinate regularly.
- Have severe incontinence product related skin problems, as judged by the investigator.
- Have any type of urinary catheter(s) resulting in improved/treated urinary incontinence.
- Suffering from fecal incontinence with a severity that makes participation in the clinical investigation inappropriate, as judged by investigator.
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 |
|---|---|---|
| THD, THNNew hybrid absorbing incontinence product for day (THD) and night (THN) use. These are variants of the same product. The intervention product is a novel design that contains reusable elements allowing for a more sustainable product. | Device | Intervention arm |
Primary outcome
Change in absorbing product leakage rate
Time frame: 20 days
For each resident a success rate (SR, number of products that do not have a urine leakage outside of the product) is calculated and compared between the baseline (standard of care) and the intervention (study device).
3 secondary outcomes
Safety data
Time frame: 20 days
Skin health assessment scoring.
Time frame: 20 days
Caregiver and resident scoring perception of the investigational product compared to the reference product.
Time frame: 20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
Janice Weisman principal investigator
Lincolnshire Community Health Services NHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THD, THN in people with Urinary Incontinence, run by Essity Hygiene and Health AB at 1 site in United Kingdom.
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 6 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 19 Sep 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in absorbing product leakage rate (time frame: 20 days). 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 19 Sep 2024.