NCT02889419

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

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.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Lille Catholic University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2016-09-05
• Last updated: 2018-08-22

Locations

6 sites across 1 country: France