- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04132037
An Observational Study on Intermittent Self Catheterisation Discontinuation Factors in Multiple Sclerosis Patients (SEPAS)
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Toulouse, Frankrike, 31059
- UHToulouse
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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
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At each protocol's visit, clinical and urinary data will be recorded and the answers of the questionnaires will be also reported
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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intermittent self catheterisation discontinuation at 2 years after the start of learning.
Tidsramme: 2 years
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intermittent self catheterisation frequency and the adherence scorage will be evaluated for each patient.
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2 years
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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intermittent self catheterisation discontinuation at 6 weeks, after the start of learning.
Tidsramme: 6 WEEKS
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intermittent self catheterisation frequency will be evaluated for each patient.
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6 WEEKS
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intermittent self catheterisation discontinuation 6 months after the start of learning.
Tidsramme: 6 months
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intermittent self catheterisation frequency will be evaluated for each patient.
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6 months
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intermittent self catheterisation discontinuation at 1 year after the start of learning.
Tidsramme: 1 year
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intermittent self catheterisation frequency will be evaluated for each patient.
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1 year
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: castel lacanal EVELYNE, University Hospital, Toulouse
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RC31/18/0354
- 2019-A00327-50 (Annen identifikator: ID-RCB)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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