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

Primary Purpose

Multiple Sclerosis

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evaluation of underwear Selfia®
Sponsored by
Lille Catholic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Disability, Underwear, Urinary catheter, Self-catheterisation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Groupement des Hôpitaux de l'Institut Catholique de Lille
  • Clinique Saint-Augustin
  • Hôpital Swynghedauw - CHRU de Lille
  • Cabinet médical de Neurologie
  • Hôpital Saint-Jacques - CHU Nantes
  • Pôle MPR Saint Hélier

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Evaluation of underwear Selfia®

Arm Description

Every patient is his own control.

Outcomes

Primary Outcome Measures

Average time spend for the realization of a self-catheterisation, from undressing to dressing, measured by a chronometer provided to the patient

Secondary Outcome Measures

Measure of the quality of life
Specific scale adapted for the studied population: Qualiveen (self-questionnaire for MS patients with urinary disorders)
Measure of fatigue for every SC
EVA scale
Comfort linked to SC
EVA scale for pain linked to undressing / dressing
Consequences from SC complications
Number of bleeding, EVA scale for the pain linked to the introduction / withdraw of the urinary catheter,
Number of documented urinary infections
Number of self-catheterisation or hetero-catheterisation per day
Opinion of the patient (favorable/non favorable) on the use of underwear Selfia ®
Re-use (yes/no) of underwear with or without purchase (yes/no)

Full Information

First Posted
August 31, 2016
Last Updated
August 20, 2018
Sponsor
Lille Catholic University
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1. Study Identification

Unique Protocol Identification Number
NCT02889419
Brief Title
Benefits Evaluation of Selfia® Adapted Underwear for MS Patients Performing Self-catheterization
Acronym
KML
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Withdrawn
Study Start Date
January 2017 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Disability, Underwear, Urinary catheter, Self-catheterisation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evaluation of underwear Selfia®
Arm Type
Experimental
Arm Description
Every patient is his own control.
Intervention Type
Device
Intervention Name(s)
Evaluation of underwear Selfia®
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Measure of the quality of life
Description
Specific scale adapted for the studied population: Qualiveen (self-questionnaire for MS patients with urinary disorders)
Time Frame
17 days
Title
Measure of fatigue for every SC
Description
EVA scale
Time Frame
17 days
Title
Comfort linked to SC
Description
EVA scale for pain linked to undressing / dressing
Time Frame
17 days
Title
Consequences from SC complications
Description
Number of bleeding, EVA scale for the pain linked to the introduction / withdraw of the urinary catheter,
Time Frame
17 days
Title
Number of documented urinary infections
Time Frame
17 days
Title
Number of self-catheterisation or hetero-catheterisation per day
Time Frame
17 days
Title
Opinion of the patient (favorable/non favorable) on the use of underwear Selfia ®
Time Frame
at 6 months and at 1 year
Title
Re-use (yes/no) of underwear with or without purchase (yes/no)
Time Frame
at 6 months and at 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène Cattoir-Vue, MD
Organizational Affiliation
Groupement des Hôpitaux de l'Institut Catholique de Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupement des Hôpitaux de l'Institut Catholique de Lille
City
Lomme
State/Province
Nord Pas-de-Calais
ZIP/Postal Code
59462
Country
France
Facility Name
Clinique Saint-Augustin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital Swynghedauw - CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Cabinet médical de Neurologie
City
Lyon
ZIP/Postal Code
69006
Country
France
Facility Name
Hôpital Saint-Jacques - CHU Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Pôle MPR Saint Hélier
City
Rennes
ZIP/Postal Code
35043
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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