Urinary IncontinenceNCT05031442
Study of Pant Type Absorbing Urinary Incontinence Products
A study testing RH1 (low waist), Reference variant 1 (low waist) and RC2 (high waist) in people with Urinary Incontinence, run by Essity Hygiene and Health AB at 3 sites in France.
Trial summary
Pre-market feasibility clinical investigation designed to evaluate the clinical performance and safety of the investigational product in its intended target population Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- RH1 (low waist), Reference variant 1 (low waist) and RC2 (high waist)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- 23 Aug 2021to 12 Nov 2021
- 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 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult women between age 45 and 75.
- Be willing and able to provide informed consent.
- Capability and willingness to follow the protocol.
- Experience incontinence daily or at least two times a week.
- Uses some sort of protection for the incontinence daily or at least two times a week.
- Uses five or more pieces of protection per week.
Show all 10Show fewer
- Is currently using protective underwear; a pull-up (pant) product made for incontinence.
- Is able to wear a pant product of size M.
- Is currently using TENA Silhouette or Always Discreet Boutique product.
- Should be affiliate to the social security system.
Who cannot join
- Is pregnant or nursing.
- Known allergies or intolerances to one or several components of the investigational products.
- Be dependent on either alcohol or recreational drugs.
- 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.
- Being under safeguard and protection of justice
- Having cognitive impairments.
- Any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Eurofins Optimed
Gières, 38610
Intertek
Paris, 75013
LyREC
Pierre-Bénite, 69310
About this study
Official title: A Randomized Study of Pant Type Absorbing Urinary Incontinence Products With Cross-over Design
Pre-market feasibility clinical investigation designed to evaluate the clinical performance and safety of the investigational product in its intended target population
Read the detailed description
The clinical clinical investigation is prospective, cross-over, interventional, multicentre and pre-market. The investigation aims to demonstrate the performance and safety of a new absorbing hygiene product (medical device) when used as intended in subjects affected with light to medium urinary incontinence compared to a reference (control) product representing standard of care.
The study participants will be randomly assigned to one of 4 groups. Each group will receive a predefined pair of investigational and reference products (variants: either high waist or low waist) to be used in a predefined order (crossover design: investigational or reference product to be used first). Hence, each study subject will use two products (one investigational product and a corresponding reference product of the same variant) and act as its own control. The study subjects will use one product for 5 days and then switch to use the other product for 5 days.
The primary endpoint for the investigation is the comparison in leakage performance of the investigation product with the reference product. There are also secondary endpoints regarding safety and product satisfaction and product preference.
- Conditions
- Urinary Incontinence
- Being tested
- RH1 (low waist), Reference variant 1 (low waist), RC2 (high waist), Reference variant 2 (high waist)
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RH1 (low waist)Device
Investigational product variant 1 low waist
Reference variant 1 (low waist)Device
Also called TENA Silhouette Normal Low waist
Reference product variant 1
RC2 (high waist)Device
Investigational product variant 2 high waist
Reference variant 2 (high waist)Device
Also called TENA Silhouette Normal High waist
Reference product variant 2
| Study group | Role | What they receive |
|---|---|---|
| low waist arm (investigational product RH1 first) | Other | Investigational product RH1 (low waist) will be used for 5 consecutive days at the start before switching to the control product (low waist) for 5 days after cross-over. Receives: Device: RH1 (low waist); Device: Reference variant 1 (low waist) |
| high waist arm (Investigational product RC2 first) | Other | Investigational product RC2 (high waist) to be used for 5 consecutive days at the start before switching to the control product (high waist) for 5 days after cross-over. Receives: Device: RC2 (high waist); Device: Reference variant 2 (high waist) |
| low waist arm (Control product first) | Other | Control product (low waist) to be used for 5 consecutive days at the start before switching to the investigational product RH1 for 5 days after cross-over. Receives: Device: RH1 (low waist); Device: Reference variant 1 (low waist) |
| high waist (Control product first) | Other | Control product (high waist) to be used for 5 consecutive days at the start before switching to the investigational product RC2 for 5 days after cross-over. Receives: Device: RC2 (high waist); Device: Reference variant 2 (high waist) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diary reported number of urinary leakages
The proportion of products experiencing urine leakage over the 5 day test period is compared between the investigational and reference product. A diary is used to collect this information for each used product.
Measured: Through study completion until Day 12 +/-2
Secondary outcomes (4)
Incidence of safety events
The number and severity of reported safety events are collected and compared for the intervention and reference products.
Measured: Through study completion until Day 12 +/-2
Product satisfaction questionnaire
Overall satisfaction score with investigational product as compared to the reference product using a 5-point likert scale.
Measured: Day 6 +/-1
Product satisfaction questionnaire
Overall satisfaction score with investigational product as compared to the reference product using a 5-point likert scale.
Measured: Day 12 +/-2
Product preference questionnaire
Subject preference score for the investigational product as compared to the reference product using a 5-point likert scale.
Measured: Measured on day 12 +/-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start23 Aug 2021
- Primary completion19 Oct 2021
- Study completion12 Nov 2021
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects use one product for 5 days and then switch to another product for 5 days. One of the products is the investigational product and one is the reference product.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essity Hygiene and Health AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nathalie Paquet Labertrande, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031442
- Sponsor's protocol ID
- R-ONE
- Status last verified
- Nov 2021
- First submitted
- 11 Aug 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Pant Type Absorbing Urinary Incontinence Products With Cross-over Design
- ClinicalTrials.gov ID
- NCT05031442
- Acronym / sponsor ID
- R-ONE
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Essity Hygiene and Health ABIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 1 Sep 2021 (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.
Pre-market feasibility clinical investigation designed to evaluate the clinical performance and safety of the investigational product in its intended target population
Detailed description
The clinical clinical investigation is prospective, cross-over, interventional, multicentre and pre-market. The investigation aims to demonstrate the performance and safety of a new absorbing hygiene product (medical device) when used as intended in subjects affected with light to medium urinary incontinence compared to a reference (control) product representing standard of care.
The study participants will be randomly assigned to one of 4 groups. Each group will receive a predefined pair of investigational and reference products (variants: either high waist or low waist) to be used in a predefined order (crossover design: investigational or reference product to be used first). Hence, each study subject will use two products (one investigational product and a corresponding reference product of the same variant) and act as its own control. The study subjects will use one product for 5 days and then switch to use the other product for 5 days.
The primary endpoint for the investigation is the comparison in leakage performance of the investigation product with the reference product. There are also secondary endpoints regarding safety and product satisfaction and product preference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Subjects use one product for 5 days and then switch to another product for 5 days. One of the products is the investigational product and one is the reference product.
| Arm | Type | Receives |
|---|---|---|
| low waist arm (investigational product RH1 first) | Other | Device: RH1 (low waist), Device: Reference variant 1 (low waist)Investigational product RH1 (low waist) will be used for 5 consecutive days at the start before switching to the control product (low waist) for 5 days after cross-over. |
| high waist arm (Investigational product RC2 first) | Other | Device: RC2 (high waist), Device: Reference variant 2 (high waist)Investigational product RC2 (high waist) to be used for 5 consecutive days at the start before switching to the control product (high waist) for 5 days after cross-over. |
| low waist arm (Control product first) | Other | Device: RH1 (low waist), Device: Reference variant 1 (low waist)Control product (low waist) to be used for 5 consecutive days at the start before switching to the investigational product RH1 for 5 days after cross-over. |
| high waist (Control product first) | Other | Device: RC2 (high waist), Device: Reference variant 2 (high waist)Control product (high waist) to be used for 5 consecutive days at the start before switching to the investigational product RC2 for 5 days after cross-over. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult women between age 45 and 75.
- Be willing and able to provide informed consent.
- Capability and willingness to follow the protocol.
- Experience incontinence daily or at least two times a week.
- Uses some sort of protection for the incontinence daily or at least two times a week.
Key exclusion criteria (7 listed)
- Is pregnant or nursing.
- Known allergies or intolerances to one or several components of the investigational products.
- Be dependent on either alcohol or recreational drugs.
- 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.
- Being under safeguard and protection of justice
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 |
|---|---|---|
| RH1 (low waist)Investigational product variant 1 low waist | Device | low waist arm (Control product first), low waist arm (investigational product RH1 first) |
| Reference variant 1 (low waist)Also: TENA Silhouette Normal Low waistReference product variant 1 | Device | low waist arm (Control product first), low waist arm (investigational product RH1 first) |
| RC2 (high waist)Investigational product variant 2 high waist | Device | high waist (Control product first), high waist arm (Investigational product RC2 first) |
| Reference variant 2 (high waist)Also: TENA Silhouette Normal High waistReference product variant 2 | Device | high waist (Control product first), high waist arm (Investigational product RC2 first) |
Primary outcome
Diary reported number of urinary leakages
Time frame: Through study completion until Day 12 +/-2
The proportion of products experiencing urine leakage over the 5 day test period is compared between the investigational and reference product. A diary is used to collect this information for each used product.
4 secondary outcomes
Incidence of safety events
Time frame: Through study completion until Day 12 +/-2
Product satisfaction questionnaire
Time frame: Day 6 +/-1
Product satisfaction questionnaire
Time frame: Day 12 +/-2
Product preference questionnaire
Time frame: Measured on day 12 +/-2
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 24 Nov 2021.
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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.
Nathalie Paquet Labertrande, MD principal investigator
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RH1 (low waist), Reference variant 1 (low waist) and RC2 (high waist) in people with Urinary Incontinence, run by Essity Hygiene and Health AB at 3 sites in France.
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 10 inclusion and 7 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 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Diary reported number of urinary leakages (time frame: Through study completion until Day 12 +/-2). 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 24 Nov 2021.