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.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 12
- 主要终点
- Average time spend for the realization of a self-catheterisation, from undressing to dressing, measured by a chronometer provided to the patient
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Evaluation of underwear Selfia®
Every patient is his own control.
干预措施: Evaluation of underwear Selfia® (Device)
结局指标
主要结局
Average time spend for the realization of a self-catheterisation, from undressing to dressing, measured by a chronometer provided to the patient
时间窗: 17 days
次要结局
- Opinion of the patient (favorable/non favorable) on the use of underwear Selfia ®(at 6 months and at 1 year)
- Comfort linked to SC(17 days)
- Measure of the quality of life(17 days)
- Consequences from SC complications(17 days)
- Measure of fatigue for every SC(17 days)
- Number of documented urinary infections(17 days)
- Number of self-catheterisation or hetero-catheterisation per day(17 days)
- Re-use (yes/no) of underwear with or without purchase (yes/no)(at 6 months and at 1 year)