Multiple SclerosisKMLNCT02889419
Benefits Evaluation of Selfia® Adapted Underwear for MS Patients Performing Self-catheterization
A study testing Evaluation of underwear Selfia® in people with Multiple Sclerosis, run by Lille Catholic University at 6 sites in France.
Trial summary
KML is a multicenter, prospective, uncontrolled and before/after study. The study aims to estimate if the use of Selfia ® adapted underwear reduces the necessary duration for the realization of self-catheterisation (SC) for patients affected by multiple sclerosis with severe to moderate disability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Evaluation of underwear Selfia®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesFrance
- Study dates
- Jan 2017to Jun 2020
- 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
- Patients with multiple sclerosis (MS) according to McDonald criteria
- At least 18 years old
- Self-catheterization for at least 3 months
- Expended Disability Status Scale (EDSS) between 6.0 and 7.5
- Informed consent
- Coverage of the social insurance
Who cannot join
- MS relapse in the previous month
- Patient hospitalized in short stay or aftercare departments, no matter the reason
- Morbid obesity (BMI superior to 35)
- Understanding disorders preventing an informed consent
- EDSS inferior to 6.0 or superior to 7.5
- Patient with home bladder catheter
Show all 10Show fewer
- No capacity to provide a self-catheterisation
- Age under 18 years
- Pregnant or breast-feeding woman
- Patient under legal protection
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Clinique Saint-Augustin
Bordeaux, 33076
Hôpital Swynghedauw - CHRU de Lille
Lille, 59037
Groupement des Hôpitaux de l'Institut Catholique de Lille
Lomme, Hauts-de-France, 59462
Cabinet médical de Neurologie
Lyon, 69006
Hôpital Saint-Jacques - CHU Nantes
Nantes, 44093
Pôle MPR Saint Hélier
Rennes, 35043
About this study
Official title: Benefits Evaluation of Selfia® Adapted Underwear for Multiple Sclerosis Patients With Severe to Moderate Handicap Performing Self-catheterization : a Multicenter, Prospective, Uncontrolled and Before/After Study.
KML is a multicenter, prospective, uncontrolled and before/after study. The study aims to estimate if the use of Selfia ® adapted underwear reduces the necessary duration for the realization of self-catheterisation (SC) for patients affected by multiple sclerosis with severe to moderate disability.
Secondly, the study aims to :
- Estimate the effect of underwear on quality of life, tiredness linked to the act, comfort in the realization of SC, complications with SC, third party intervention ;
- Collect patients' opinion on the use of the underwear SELFIA ® at the end of the 2nd week of evaluation ;
- Measure if the patient reused underwear and if he bought it at 6 months and at 1 year
Read the detailed description
Bladder-sphincter disorders affect 80 % of the patients suffering from multiple sclerosis (MS) after 10 years of evolution and urinary self-catheterization (SC) are part of the therapeutic arsenal.
SC involves different steps: the preparation of the material, the undressing, the transfer on toilets, the technical gesture and the dressing. Recommendations of good practice of SC of the French Society of Physical Medicine and Rehabilitation evoke the necessity to adapt the wardrobe but without precision on the definition of this adaptation.
Adapted underwear exists for patients with a disability and is accessible for the general public. However, no clinical trial has ever evaluated their real practical interest for disabled patients realizing SC.
These undergarments, according to our experience, are very ingenious and would bring a real comfort in everyday life from patients with a disability.
In case of SC, this underwear would facilitate and shorten the time dedicated to this technique, especially as SC are realized on average 6 times a day for patients already affected in their movements because of their initial handicap.
The adapted underwear could bring an ease and a speed of dressing / undressing, allow an easier and faster access to the urinary meatus and a limitation of manipulations and mobilizations of the patient allowing an energy saving.
Moreover, disabled patients request concrete advice from health professionals on everyday life problems such as dressing / undressing. Therefore it seemed interesting to estimate the benefits of using adapted underwear for the realization of SC for patients affected by MS with severe to moderate disability (EDSS 6 - 7.5) affecting everyday life activities.
- Conditions
- Multiple Sclerosis
- Being tested
- Evaluation of underwear Selfia®
- Keywords
- Multiple Sclerosis, Disability, Underwear, Urinary catheter, Self-catheterisation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of underwear Selfia®Device
Patients are evaluated for a week using their usual underwear for the realization of SC. At the end of the week, they receive Selfia ® adaptated underwear and they use it for one week for a new evaluation. Finally, underwear will be given to patients and during follow-up consultations in routine at 6 months and 1 year, he will be asked if they reused or bought underwear.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of underwear Selfia® | Experimental | Every patient is his own control. Receives: Device: Evaluation of underwear Selfia® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average time spend for the realization of a self-catheterisation, from undressing to dressing, measured by a chronometer provided to the patient
Measured: 17 days
Secondary outcomes (8)
Measure of the quality of life
Specific scale adapted for the studied population: Qualiveen (self-questionnaire for MS patients with urinary disorders)
Measured: 17 days
Measure of fatigue for every SC
EVA scale
Measured: 17 days
Comfort linked to SC
EVA scale for pain linked to undressing / dressing
Measured: 17 days
Consequences from SC complications
Number of bleeding, EVA scale for the pain linked to the introduction / withdraw of the urinary catheter,
Measured: 17 days
Number of documented urinary infections
Measured: 17 days
Number of self-catheterisation or hetero-catheterisation per day
Measured: 17 days
Opinion of the patient (favorable/non favorable) on the use of underwear Selfia ®
Measured: at 6 months and at 1 year
Re-use (yes/no) of underwear with or without purchase (yes/no)
Measured: at 6 months and at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène Cattoir-Vue, MD, Principal investigator, Groupement des Hôpitaux de l'Institut Catholique de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889419
- Sponsor's protocol ID
- RC-P0045
- Acronym
- KML
- Status last verified
- Aug 2018
- First submitted
- 31 Aug 2016
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits Evaluation of Selfia® Adapted Underwear for Multiple Sclerosis Patients With Severe to Moderate Handicap Performing Self-catheterization : a Multicenter, Prospective, Uncontrolled and Before/After Study.
- ClinicalTrials.gov ID
- NCT02889419
- Acronym / sponsor ID
- KML / RC-P0045
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Disability, Underwear, Urinary catheter, Self-catheterisation
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 5 Sep 2016 (estimated)
- 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.
KML is a multicenter, prospective, uncontrolled and before/after study. The study aims to estimate if the use of Selfia ® adapted underwear reduces the necessary duration for the realization of self-catheterisation (SC) for patients affected by multiple sclerosis with severe to moderate disability.
Secondly, the study aims to :
- Estimate the effect of underwear on quality of life, tiredness linked to the act, comfort in the realization of SC, complications with SC, third party intervention ;
- Collect patients' opinion on the use of the underwear SELFIA ® at the end of the 2nd week of evaluation ;
- Measure if the patient reused underwear and if he bought it at 6 months and at 1 year
Detailed description
Bladder-sphincter disorders affect 80 % of the patients suffering from multiple sclerosis (MS) after 10 years of evolution and urinary self-catheterization (SC) are part of the therapeutic arsenal.
SC involves different steps: the preparation of the material, the undressing, the transfer on toilets, the technical gesture and the dressing. Recommendations of good practice of SC of the French Society of Physical Medicine and Rehabilitation evoke the necessity to adapt the wardrobe but without precision on the definition of this adaptation.
Adapted underwear exists for patients with a disability and is accessible for the general public. However, no clinical trial has ever evaluated their real practical interest for disabled patients realizing SC.
These undergarments, according to our experience, are very ingenious and would bring a real comfort in everyday life from patients with a disability.
In case of SC, this underwear would facilitate and shorten the time dedicated to this technique, especially as SC are realized on average 6 times a day for patients already affected in their movements because of their initial handicap.
The adapted underwear could bring an ease and a speed of dressing / undressing, allow an easier and faster access to the urinary meatus and a limitation of manipulations and mobilizations of the patient allowing an energy saving.
Moreover, disabled patients request concrete advice from health professionals on everyday life problems such as dressing / undressing. Therefore it seemed interesting to estimate the benefits of using adapted underwear for the realization of SC for patients affected by MS with severe to moderate disability (EDSS 6 - 7.5) affecting everyday life activities.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of underwear Selfia® | Experimental | Device: Evaluation of underwear Selfia®Every patient is his own control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with multiple sclerosis (MS) according to McDonald criteria
- At least 18 years old
- Self-catheterization for at least 3 months
- Expended Disability Status Scale (EDSS) between 6.0 and 7.5
- Informed consent
Key exclusion criteria (10 listed)
- MS relapse in the previous month
- Patient hospitalized in short stay or aftercare departments, no matter the reason
- Morbid obesity (BMI superior to 35)
- Understanding disorders preventing an informed consent
- EDSS inferior to 6.0 or superior to 7.5
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 |
|---|---|---|
| Evaluation of underwear Selfia®Patients are evaluated for a week using their usual underwear for the realization of SC. At the end of the week, they receive Selfia ® adaptated underwear and they use it for one week for a new evaluation. Finally, underwear will be given to patients and during follow-up consultations in routine at 6 months and 1 year, he will be asked if they reused or bought underwear. | Device | Evaluation of underwear Selfia® |
Primary outcome
Average time spend for the realization of a self-catheterisation, from undressing to dressing, measured by a chronometer provided to the patient
Time frame: 17 days
8 secondary outcomes
Measure of the quality of life
Time frame: 17 days
Measure of fatigue for every SC
Time frame: 17 days
Comfort linked to SC
Time frame: 17 days
Consequences from SC complications
Time frame: 17 days
Number of documented urinary infections
Time frame: 17 days
Number of self-catheterisation or hetero-catheterisation per day
Time frame: 17 days
Opinion of the patient (favorable/non favorable) on the use of underwear Selfia ®
Time frame: at 6 months and at 1 year
Re-use (yes/no) of underwear with or without purchase (yes/no)
Time frame: at 6 months and at 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- 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.
Hélène Cattoir-Vue, MD principal investigator
Groupement des Hôpitaux de l'Institut Catholique de Lille
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of underwear Selfia® in people with Multiple Sclerosis, run by Lille Catholic University at 6 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 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: withdrawn, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 was withdrawn before enrolling participants, so there are no results.
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?
Average time spend for the realization of a self-catheterisation, from undressing to dressing, measured by a chronometer provided to the patient (time frame: 17 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 22 Aug 2018.