Benefits Evaluation of Selfia® Adapted Underwear for MS Patients Perfo
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.
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
- Evaluation of underwear Selfia®
What it measured
Main measures
Average time spend for the realization of a self-catheterisation, from undressing to dressing, measured by a chronometer provided to the patient
17 days
Other measures (8)
Measure of the quality of life
17 days
Bladder, bowel and sexual functionQuality of life (reported by participants)Measure of fatigue for every SC
17 days
FatigueComfort linked to SC
17 days
PainConsequences from SC complications
17 days
Bladder, bowel and sexual functionPainNumber of documented urinary infections
17 days
Bladder, bowel and sexual functionNumber 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
Who could take part
MS (type not specified) · 18 and over · EDSS 6.0 to 7.5
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
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History
Started
Jan 2017
Main results due
Jun 2020
Finished
Jun 2020