An Observational Study on Intermittent Self Catheterisation Discontinuation Factors in Multiple Sclerosis Patients

Study Overview
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Brief Summary
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Urinary disorders (UD) are common in Multiple Sclerosis (MS) and can necessitate using Intermittent Self Catheterisation (ISC). It is well experienced by patients, has little impact on daily life and improves quality of life. However, studies are lacking on long-term adherence to this treatment as well as on discontinuation factors. Our main objective is to prospectively assessed factors associated with ISC discontinuation 2 years after having introduced this technique.

Detailed Description
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Urinary disorders (UD) are common in Multiple Sclerosis (MS). About 65% of patients suffering from moderate to severe troubles. In case of voiding dysfunction, the reference treatment is based on intermittent self catheterisation (ISC). UD in spinal cord injury (SCI) patients have been widely studied. They are very common, and are life-threatening in the absence of appropriate care. Management of neurological UD (as those occurring in MS) are well defined. ISC is the gold standard of bladder emptying method in this pathological context, and has been the subject of numerous studies. In SCI, the ISC discontinuation rate varies from 52 to 80% according to the published studies, the main factors of continuation being the autonomy to perform the technique, and the continence rate. However, the results are variable. In case of MS, the studies are lacking, the results concerning the discontinuation rate and factors associated with discontinuation are poor. Our main objective within the French speaking neurology study group (GENULF), is to prospectively assessed factors associated with ISC discontinuation 2 years after having introduced this technique. This predictive study will be multicenter, observational, analytical, and prospective and will not modify current clinical practice. We will record clinical and urinary data at each visit (inclusion, 6 weeks, 6 months, 12 months, and 24 months). We will note also if the patient practice ISC as prescribed in order to identify discontinuation of the ISC.

Official Title
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An Observational Study on Intermittent Self Catheterisation Discontinuation Factors in Multiple Sclerosis Patients

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: data record


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 18 to 65 years Patient with MS First ISC prescription Patient giving informed consent Patient affiliated to the social security system Exclusion Criteria: Patient who has already tried / practiced ISC Patient under safeguard of justice / guardianship / tutorship Pregnant or lactating woman

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patient with multiple sclerosis<br>At each visit, inclusion, 6 weeks, 6 months, 12 months, and 24 months, the clinical and urinary data will be recorded and the ISC frequency , ISC discontinuation and adherence scale will be evaluated | Other: data record<br>* At each protocol's visit, clinical and urinary data will be recorded and the answers of the questionnaires will be also reported<br>* Other names: questionnaires;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intermittent self catheterisation discontinuation at 2 years after the start of learning. | intermittent self catheterisation frequency and the adherence scorage will be evaluated for each patient. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intermittent self catheterisation discontinuation at 6 weeks, after the start of learning. | intermittent self catheterisation frequency will be evaluated for each patient. | 6 WEEKS | 
| intermittent self catheterisation discontinuation 6 months after the start of learning. | intermittent self catheterisation frequency will be evaluated for each patient. | 6 months | 
| intermittent self catheterisation discontinuation at 1 year after the start of learning. | intermittent self catheterisation frequency will be evaluated for each patient. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Urinary disorders, Intermittent Self Catheterisation