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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 :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluation of underwear Selfia® | Experimental | Every patient is his own control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Average time spend for the realization of a self-catheterisation, from undressing to dressing, measured by a chronometer provided to the patient | 17 days |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of the quality of life | Specific scale adapted for the studied population: Qualiveen (self-questionnaire for MS patients with urinary disorders) | 17 days |
| Measure of fatigue for every SC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hélène Cattoir-Vue, MD | Groupement des Hôpitaux de l'Institut Catholique de Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupement des Hôpitaux de l'Institut Catholique de Lille | Lomme | Hauts-de-France | 59462 | France | ||
| Clinique Saint-Augustin |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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|
EVA scale
| 17 days |
| Comfort linked to SC | EVA scale for pain linked to undressing / dressing | 17 days |
| Consequences from SC complications | Number of bleeding, EVA scale for the pain linked to the introduction / withdraw of the urinary catheter, | 17 days |
| Number of documented urinary infections | 17 days |
| Number of self-catheterisation or hetero-catheterisation per day | 17 days |
| Opinion of the patient (favorable/non favorable) on the use of underwear Selfia ® | at 6 months and at 1 year |
| Re-use (yes/no) of underwear with or without purchase (yes/no) | at 6 months and at 1 year |
| Bordeaux |
| 33076 |
| France |
| Hôpital Swynghedauw - CHRU de Lille | Lille | 59037 | France |
| Cabinet médical de Neurologie | Lyon | 69006 | France |
| Hôpital Saint-Jacques - CHU Nantes | Nantes | 44093 | France |
| Pôle MPR Saint Hélier | Rennes | 35043 | France |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |