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

NCT ID: NCT04132037

Last Updated: 2019-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 225 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-26
• Study Completion Date: 2022-12-31

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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

patient with multiple sclerosis

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

data record

Intervention Type: OTHER

At each protocol's visit, clinical and urinary data will be recorded and the answers of the questionnaires will be also reported

Interventions

data record

At each protocol's visit, clinical and urinary data will be recorded and the answers of the questionnaires will be also reported

Intervention Type: OTHER

Other Intervention Names

questionnaires

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

French Association for Research on Multiple Sclerosis

UNKNOWN

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

castel lacanal EVELYNE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

UHToulouse

Toulouse, , France

Countries

France

Other Identifiers

2019-A00327-50

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/18/0354

Identifier Type: -

Identifier Source: org_study_id