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

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.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: data record

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.

• Study Type: Observational
• Enrollment (Anticipated): 225

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • UHToulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Multiple Sclerosis Patients requiring Intermittent Self Catheterisation

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; At each protocol's visit, clinical and urinary data will be recorded and the answers of the questionnaires will be also reported; Other Names: questionnaires

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: French Association for Research on Multiple Sclerosis
• Investigators: Principal Investigator: castel lacanal EVELYNE, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2019
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): October 18, 2019
• Last Update Submitted That Met QC Criteria: October 17, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Urinary disorders; Intermittent Self Catheterisation
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: RC31/18/0354; 2019-A00327-50 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No