NCT02889419

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

6 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

3.4 years

First QC Date

August 31, 2016

Last Update Submit

August 20, 2018

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisDisabilityUnderwearUrinary catheterSelf-catheterisation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Measure of the quality of life

    17 days

  • Measure of fatigue for every SC

    17 days

  • Comfort linked to SC

    17 days

  • Consequences from SC complications

    17 days

  • Number of documented urinary infections

    17 days

  • +3 more secondary outcomes

Study Arms (1)

Evaluation of underwear Selfia®

EXPERIMENTAL

Every patient is his own control.

Device: Evaluation of underwear Selfia®

Interventions

Evaluation of underwear Selfia®DEVICE

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.

Evaluation of underwear Selfia®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Groupement des Hôpitaux de l'Institut Catholique de Lille

Lomme, Hauts-de-France, 59462, France

Location

Clinique Saint-Augustin

Bordeaux, 33076, France

Location

Hôpital Swynghedauw - CHRU de Lille

Lille, 59037, France

Location

Cabinet médical de Neurologie

Lyon, 69006, France

Location

Hôpital Saint-Jacques - CHU Nantes

Nantes, 44093, France

Location

Pôle MPR Saint Hélier

Rennes, 35043, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Hélène Cattoir-Vue, MD

    Groupement des Hôpitaux de l'Institut Catholique de Lille

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 5, 2016

Study Start

January 1, 2017

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

August 22, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)