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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04132037
Acronym
SEPAS
Enrollment
225
Registered
2019-10-18
Start date
2019-06-26
Completion date
2022-12-31
Last updated
2019-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, Urinary disorders, 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.

Interventions

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

Sponsors

French Association for Research on Multiple Sclerosis
CollaboratorUNKNOWN
University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
intermittent self catheterisation discontinuation at 2 years after the start of learning.2 yearsintermittent self catheterisation frequency and the adherence scorage will be evaluated for each patient.

Secondary

MeasureTime frameDescription
intermittent self catheterisation discontinuation at 6 weeks, after the start of learning.6 WEEKSintermittent self catheterisation frequency will be evaluated for each patient.
intermittent self catheterisation discontinuation 6 months after the start of learning.6 monthsintermittent self catheterisation frequency will be evaluated for each patient.
intermittent self catheterisation discontinuation at 1 year after the start of learning.1 yearintermittent self catheterisation frequency will be evaluated for each patient.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026