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

• ClinicalTrials.gov Identifier: NCT02889419
• Recruitment Status: Withdrawn
• First Posted: September 5, 2016
• Last Update Posted: August 22, 2018
• Sponsor: Lille Catholic University
• Information provided by (Responsible Party): Lille Catholic University

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

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis	Device: Evaluation of underwear Selfia®	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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 Start Date: January 2017
• Estimated Primary Completion Date: June 2020
• Estimated Study Completion Date: June 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. Measure of the quality of life [ Time Frame: 17 days ]
   Specific scale adapted for the studied population: Qualiveen (self-questionnaire for MS patients with urinary disorders)
2. Measure of fatigue for every SC [ Time Frame: 17 days ]
   EVA scale
3. Comfort linked to SC [ Time Frame: 17 days ]
   EVA scale for pain linked to undressing / dressing
4. Consequences from SC complications [ Time Frame: 17 days ]
   Number of bleeding, EVA scale for the pain linked to the introduction / withdraw of the urinary catheter,
5. Number of documented urinary infections [ Time Frame: 17 days ]
6. Number of self-catheterisation or hetero-catheterisation per day [ Time Frame: 17 days ]
7. Opinion of the patient (favorable/non favorable) on the use of underwear Selfia ® [ Time Frame: at 6 months and at 1 year ]
8. Re-use (yes/no) of underwear with or without purchase (yes/no) [ Time Frame: at 6 months and at 1 year ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

France

Groupement des Hôpitaux de l'Institut Catholique de Lille

Lomme, Nord Pas-de-Calais, France, 59462

Clinique Saint-Augustin

Bordeaux, France, 33076

Hôpital Swynghedauw - CHRU de Lille

Lille, France, 59037

Cabinet médical de Neurologie

Lyon, France, 69006

Hôpital Saint-Jacques - CHU Nantes

Nantes, France, 44093

Pôle MPR Saint Hélier

Rennes, France, 35043

Sponsors and Collaborators

Lille Catholic University

Investigators

• Principal Investigator: Hélène Cattoir-Vue, MD; Groupement des Hôpitaux de l'Institut Catholique de Lille

More Information

• Responsible Party: Lille Catholic University
• ClinicalTrials.gov Identifier: NCT02889419
• Other Study ID Numbers: RC-P0045
• First Posted: September 5, 2016
• Last Update Posted: August 22, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Lille Catholic University:

Multiple Sclerosis; Disability; Underwear; Urinary catheter; Self-catheterisation

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases