Urinary IncontinenceNCT05484388
Evaluation of Urine Leakage of New Absorbing Incontinence Products in a Home Care Environment
A study testing SN2 and SP3 in people with Urinary Incontinence, run by Essity Hygiene and Health AB at 1 site in Germany.
Trial summary
The aim of this interventional but non-invasive, clinical investigation is to demonstrate the performance and safety of two new class I medical device Absorbing Hygiene Products developed by Essity. 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?
- SN2 and SP3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- 3 Oct 2022to 3 Feb 2023
- 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
- criteria to be eligible for this clinical investigation:
- Subject is diagnosed with moderate to severe urinary incontinence managed only with TENA Pants absorbent hygiene products of size Medium or Large with the same absorption level that is used in the study since at least 4 weeks.
- Subject is living at home and should have a care giving relative supported by a professional caregiver giver to manage daily activities and incontinence related tasks.
- Subject 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 subject.
- Care giving relative is willing and able to provide informed consent to participate in the clinical investigation.
- If incontinence is managed by pharmaceuticals, the dose regime is stable.
- Subject and care giving relative (if any) are over 18 years of age.
- Post-menopausal women or no longer of child-bearing potential
Who cannot join
- Subject is cared for in a professional establishment or is institutionalized.
- Subject has severe incontinence product related skin problems corresponding to scores equal to or higher than 4 in the skin health assessment, as judged by the investigator.
- Subject suffers from regular faecal incontinence more than once a week.
- Subject has any type of urinary catheter(s) resulting in improved/treated urinary incontinence.
- Any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
- Subject or care giving relative is incapable or unwilling to collect used products and fill out the bag label required for the clinical investigation.
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- Participation in another investigational study of a drug, biologic, or medical device within 30 days prior to entering the clinical investigation or planned during the clinical investigation as well as prior participation in this investigation
- Subject is pregnant or nursing or of childbearing potential.
- Investigator suspects that subject or care giving relative has an alcohol or drug addiction.
- Subject and/or caregiving relative is closely affiliated with or in hierarchical dependency of the Sponsor, PI, or CRO involved in this study
- Subject's incontinence is currently managed by more than 1 type of AHP's
- Surgery or hospitalization less than 4 weeks prior to study inclusion or planned surgery hospitalization during study conduct.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Crossover Study to Evaluate Urine Leakage of Pant Type Absorbing Incontinence Products of Two Absorption Levels in a Home Care Environment
The aim of this interventional but non-invasive, clinical investigation is to demonstrate the performance and safety of two new class I medical device Absorbing Hygiene Products developed by Essity.
The primary objective is to demonstrate for each of the new products that they provide protection to leakages similar to their corresponding standard of care devices already used on the market. The target population for this clinical investigation are community living individuals suffering from moderate to severe incontinence, who may receive care by a care giving relative, by one or more caregivers and are current users of TENA Pants of the respective absorption level.
Read the detailed description
The clinical investigation will be conducted to demonstrate the performance and safety of two new class I medical device Absorbing Hygiene Products developed by Essity. The performance of the new design will be compared to that of the currently marketed TENA Pants, deemed state of the art.
To ensure that the personal preference of the study subjects are met, only current users of the marketed TENA pants will be recruited. To meet the objectives, the investigation is designed to be prospective, randomized, cross-over and interventional but not invasive with two different groups each testing one investigational-reference device pair matched to the currently used product at the time of inclusion. The study subjects will act as their own control, using one device for 10 (+ max. 3) days and then switching to the other device for additional 10 (+ max. 3) days. As for most users the avoidance of urinary leakages is the primary concern, this will be the primary outcome of the clinical investigation for each of the device pairs tested.
The used products will be collected, weighed and photographed. A subject/caregiver questionnaire will collect data on subject satisfaction and preferences. A skin health assessment will also be performed to evaluate any change in subject skin health before, during and at the end of the study.
Since the devices perform well in their intended use, leakage rate of each individual device is low, so a large number of devices needs to be tested per absorption level in order to obtain a robust assessment. Since the underlying incontinence condition is not affected by participation in the investigation, a sequential measurement series should be sufficient to meet the study objectives.
- Conditions
- Urinary Incontinence
- Being tested
- SN2, SP3
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SN2Device
Investigational device absorption level Normal
SP3Device
Investigational device absorption level Plus
| Study group | Role | What they receive |
|---|---|---|
| SN2 | Experimental | new absorbing hygiene product with absorption level Normal. Receives: Device: SN2 |
| SP3 | Experimental | new absorbing hygiene product with absorption level Plus. Receives: Device: SP3 |
| TENA Proskin Pants Normal | Other | Reference product currently used by the participant (control for SN2). Receives: Device: SN2 |
| TENA Pants Original Plus | Other | Reference product currently used by the participant (control for SP3). Receives: Device: SP3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reported number of urinary leakages
The proportion of products experiencing urine leakage over the 10 day test period is compared between the investigational and reference product. Labels are used to collect this information for each used product
Measured: 20 days
Secondary outcomes (3)
Incidence of safety events
The number and severity of reported safety events are collected and compared for the intervention and reference products
Measured: 20 days
Product Satisfaction questionnaire
To evaluate caregiver perception of and experience in using the products. Overall satisfaction score with investigational product as compared to the reference product using a 5-point likert scale.
Measured: 20 days
Skin health questionnaire
To evaluate subject's skin health for the investigational product as compared to the reference product as part of the questionnaire
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 posted2 Aug 2022
- Study start3 Oct 2022
- Primary completion7 Dec 2022
- Study completion3 Feb 2023
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a prospective, randomized 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 as follows: Prospective. Randomized cross-over. Interventional but non-invasive. Decentralized in a home-care environment. A pairwise comparative study.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essity Hygiene and Health AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Smerud Medical Research Germany Ltd
- Responsible party
- Sponsor
- Investigators
- Kilian Pankert, MD, Principal investigator, Diakonissen-Stiftungs-Krankenhaus Speyer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484388
- Sponsor's protocol ID
- SPRING
- Status last verified
- Feb 2023
- First submitted
- 15 Jun 2022
- Last updated
- 21 Feb 2023
- 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 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Study to Evaluate Urine Leakage of Pant Type Absorbing Incontinence Products of Two Absorption Levels in a Home Care Environment
- ClinicalTrials.gov ID
- NCT05484388
- Acronym / sponsor ID
- SPRING
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Essity Hygiene and Health ABIndustry (pharma, biotech, devices)
- Collaborators
- Smerud Medical Research Germany Ltd
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 2 Aug 2022 (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 aim of this interventional but non-invasive, clinical investigation is to demonstrate the performance and safety of two new class I medical device Absorbing Hygiene Products developed by Essity.
The primary objective is to demonstrate for each of the new products that they provide protection to leakages similar to their corresponding standard of care devices already used on the market. The target population for this clinical investigation are community living individuals suffering from moderate to severe incontinence, who may receive care by a care giving relative, by one or more caregivers and are current users of TENA Pants of the respective absorption level.
Detailed description
The clinical investigation will be conducted to demonstrate the performance and safety of two new class I medical device Absorbing Hygiene Products developed by Essity. The performance of the new design will be compared to that of the currently marketed TENA Pants, deemed state of the art.
To ensure that the personal preference of the study subjects are met, only current users of the marketed TENA pants will be recruited. To meet the objectives, the investigation is designed to be prospective, randomized, cross-over and interventional but not invasive with two different groups each testing one investigational-reference device pair matched to the currently used product at the time of inclusion. The study subjects will act as their own control, using one device for 10 (+ max. 3) days and then switching to the other device for additional 10 (+ max. 3) days. As for most users the avoidance of urinary leakages is the primary concern, this will be the primary outcome of the clinical investigation for each of the device pairs tested.
The used products will be collected, weighed and photographed. A subject/caregiver questionnaire will collect data on subject satisfaction and preferences. A skin health assessment will also be performed to evaluate any change in subject skin health before, during and at the end of the study.
Since the devices perform well in their intended use, leakage rate of each individual device is low, so a large number of devices needs to be tested per absorption level in order to obtain a robust assessment. Since the underlying incontinence condition is not affected by participation in the investigation, a sequential measurement series should be sufficient to meet the study objectives.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- This is a prospective, randomized 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 as follows: Prospective. Randomized cross-over. Interventional but non-invasive. Decentralized in a home-care environment. A pairwise comparative study.
| Arm | Type | Receives |
|---|---|---|
| SN2 | Experimental | Device: SN2new absorbing hygiene product with absorption level Normal. |
| SP3 | Experimental | Device: SP3new absorbing hygiene product with absorption level Plus. |
| TENA Proskin Pants Normal | Other | Device: SN2Reference product currently used by the participant (control for SN2). |
| TENA Pants Original Plus | Other | Device: SP3Reference product currently used by the participant (control for SP3). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- criteria to be eligible for this clinical investigation:
Key exclusion criteria (12 listed)
- Subject is cared for in a professional establishment or is institutionalized.
- Subject has severe incontinence product related skin problems corresponding to scores equal to or higher than 4 in the skin health assessment, as judged by the investigator.
- Subject suffers from regular faecal incontinence more than once a week.
- Subject has any type of urinary catheter(s) resulting in improved/treated urinary incontinence.
- Any other condition that may make 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 |
|---|---|---|
| SN2Investigational device absorption level Normal | Device | SN2, TENA Proskin Pants Normal |
| SP3Investigational device absorption level Plus | Device | SP3, TENA Pants Original Plus |
Primary outcome
Reported number of urinary leakages
Time frame: 20 days
The proportion of products experiencing urine leakage over the 10 day test period is compared between the investigational and reference product. Labels are used to collect this information for each used product
3 secondary outcomes
Incidence of safety events
Time frame: 20 days
Product Satisfaction questionnaire
Time frame: 20 days
Skin health questionnaire
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 21 Feb 2023.
- 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.
Kilian Pankert, MD principal investigator
Diakonissen-Stiftungs-Krankenhaus Speyer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SN2 and SP3 in people with Urinary Incontinence, run by Essity Hygiene and Health AB at 1 site in Germany.
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 12 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 21 Feb 2023. 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 Germany. 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?
Reported number of urinary leakages (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 21 Feb 2023.