Benefits Evaluation of Selfia® Adapted Underwear for MS Patients Performing Self-catheterization (KML)

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

Study Overview

• Status: Withdrawn
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: Evaluation of underwear Selfia®

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Clinique Saint-Augustin
  • Lille, France, 59037
    • Hôpital Swynghedauw - CHRU de Lille
  • Lyon, France, 69006
    • Cabinet médical de Neurologie
  • Nantes, France, 44093
    • Hôpital Saint-Jacques - CHU Nantes
  • Rennes, France, 35043
    • Pôle MPR Saint Hélier
  • Nord Pas-de-Calais
    • Lomme, Nord Pas-de-Calais, France, 59462
      • Groupement des Hôpitaux de l'Institut Catholique de Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Evaluation of underwear Selfia®; Every patient is his own control.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Principal Investigator: Hélène Cattoir-Vue, MD, Groupement des Hôpitaux de l'Institut Catholique de Lille

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: August 31, 2016
• First Submitted That Met QC Criteria: September 2, 2016
• First Posted (Estimate): September 5, 2016

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Disability; Urinary catheter; Underwear; Self-catheterisation
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: RC-P0045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No