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

NCT04132037 | Unknown

• 2 other identifiers: RC31/18/03542019-A00327-50
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Urinary disorders; Intermittent Self Catheterisation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• intermittent self catheterisation discontinuation at 6 weeks, after the start of learning.

  6 WEEKS

• intermittent self catheterisation discontinuation 6 months after the start of learning.

  6 months

• intermittent self catheterisation discontinuation at 1 year after the start of learning.

  1 year

Study Arms (1)

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

Other: data record

Interventions

data record OTHER

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

Also known as: questionnaires

patient with multiple sclerosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multiple Sclerosis Patients requiring Intermittent Self Catheterisation

You may qualify if:

• Patient aged 18 to 65 years
• Patient with MS
• First ISC prescription
• Patient giving informed consent
• Patient affiliated to the social security system

You may not qualify if:

• Patient who has already tried / practiced ISC
• Patient under safeguard of justice / guardianship / tutorship
• Pregnant or lactating woman

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• French Association for Research on Multiple Sclerosis: collaborator

Study Sites (1)

UHToulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Electronic Health Records; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Medical Records Systems, Computerized; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• castel lacanal EVELYNE

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 18, 2019
• Study Start: June 26, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: October 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)