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

NCT02889419 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-08-22

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Lille Catholic University

    lead OTHER

Principal Investigators

  • Hélène Cattoir-Vue, MD · Groupement des Hôpitaux de l'Institut Catholique de Lille

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02889419 on ClinicalTrials.gov