Clinical trial NCT04132037: An Observational Study on Intermittent Self Catheterisation Discontinuation Factors in Multiple Sclerosis Patients
Official title: An Observational Study on Intermittent Self Catheterisation Discontinuation Factors in Multiple Sclerosis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Urinary disorders
Intermittent Self Catheterisation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: French Association for Research on Multiple Sclerosis
First posted: 2019-10-18
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple Sclerosis Patients requiring Intermittent Self Catheterisation

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: intermittent self catheterisation discontinuation at 2 years after the start of learning.
timeFrame: 2 years
Secondary outcomes:
measure: intermittent self catheterisation discontinuation at 6 weeks, after the start of learning.
timeFrame: 6 WEEKS
measure: intermittent self catheterisation discontinuation 6 months after the start of learning.
timeFrame: 6 months
measure: intermittent self catheterisation discontinuation at 1 year after the start of learning.
timeFrame: 1 year
Other outcomes:
Locations:
city: Toulouse
country: France
facility: UHToulouse
Study officials:
affiliation: University Hospital, Toulouse
name: castel lacanal EVELYNE
role: PRINCIPAL_INVESTIGATOR
References: