Clinical trial NCT02889419: Benefits Evaluation of Selfia® Adapted Underwear for MS Patients Performing Self-catheterization
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Disability
Underwear
Urinary catheter
Self-catheterisation
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* No capacity to provide a self-catheterisation
* Age under 18 years
* Pregnant or breast-feeding woman
* Patient under legal protection

Primary outcomes:
measure: Average time spend for the realization of a self-catheterisation, from undressing to dressing, measured by a chronometer provided to the patient
timeFrame: 17 days
Secondary outcomes:
measure: Measure of the quality of life
timeFrame: 17 days
measure: Measure of fatigue for every SC
timeFrame: 17 days
measure: Comfort linked to SC
timeFrame: 17 days
measure: Consequences from SC complications
timeFrame: 17 days
measure: Number of documented urinary infections
timeFrame: 17 days
measure: Number of self-catheterisation or hetero-catheterisation per day
timeFrame: 17 days
measure: Opinion of the patient (favorable/non favorable) on the use of underwear Selfia ®
timeFrame: at 6 months and at 1 year
measure: Re-use (yes/no) of underwear with or without purchase (yes/no)
timeFrame: at 6 months and at 1 year
Other outcomes:
Locations:
city: Lomme
country: France
facility: Groupement des Hôpitaux de l'Institut Catholique de Lille
state: Nord Pas-de-Calais
city: Bordeaux
country: France
facility: Clinique Saint-Augustin
city: Lille
country: France
facility: Hôpital Swynghedauw - CHRU de Lille
city: Lyon
country: France
facility: Cabinet médical de Neurologie
city: Nantes
country: France
facility: Hôpital Saint-Jacques - CHU Nantes
city: Rennes
country: France
facility: Pôle MPR Saint Hélier
Study officials:
affiliation: Groupement des Hôpitaux de l'Institut Catholique de Lille
name: Hélène Cattoir-Vue, MD
role: PRINCIPAL_INVESTIGATOR
References: