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

Multiple Sclerosis Clinical Trial

— SEPAS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04132037
• Other study ID #: RC31/18/0354
• Secondary ID: 2019-A00327-50
• Status: Active, not recruiting
• Start date: June 26, 2019
• Est. completion date: December 2022

Study information

• Verified date: October 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 225
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
France	UHToulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	French Association for Research on Multiple Sclerosis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	intermittent self catheterisation discontinuation at 6 weeks, after the start of learning.	intermittent self catheterisation frequency will be evaluated for each patient.	6 WEEKS
Secondary	intermittent self catheterisation discontinuation 6 months after the start of learning.	intermittent self catheterisation frequency will be evaluated for each patient.	6 months
Secondary	intermittent self catheterisation discontinuation at 1 year after the start of learning.	intermittent self catheterisation frequency will be evaluated for each patient.	1 year