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

Multiple Sclerosis Clinical Trial

— 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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02889419
• Other study ID #: RC-P0045
• Status: Withdrawn
• Phase: N/A
• Start date: January 2017
• Est. completion date: June 2020

Study information

• Verified date: August 2018
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
France	Clinique Saint-Augustin	Bordeaux
France	Hôpital Swynghedauw - CHRU de Lille	Lille
France	Groupement des Hôpitaux de l'Institut Catholique de Lille	Lomme	Nord Pas-de-Calais
France	Cabinet médical de Neurologie	Lyon
France	Hôpital Saint-Jacques - CHU Nantes	Nantes
France	Pôle MPR Saint Hélier	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

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