Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06817707

Evaluation of Urinary Dysfunction in CANVAS Patients

Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-03-26

40

Participants Needed

3

Research Sites

101 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The investigator wishes to evaluate the prevalence of urinary symptoms in patients diagnosed with Cerebellar Ataxia, Neuropathy, Vestibular Areflexia Syndrome (CANVAS). As much as one third of patients living with CANVAS experience symptoms of urinary system dysfunction. The primary objective of this study is to evaluate the incidence of urinary symptoms in these patients, as well as the potential complications that might occur at the level of the upper and lower urinary system. The investigator also wishes to analyse the connection between the severity of the neurological deficits, the presence of dysautonomia and the presence of urinary dysfunction. To that end, the data collected in the study will concern : a detailed neurological examination including SARA (Scale for the assessement and rating of ataxia) scale assessement, laboratory tests of the renal function, dysautonomia tests with Sudoscan and research of orthostatic hypotension, urinary function questionnaires, dysautonomia questionnaire, urodynamic tests and urinary system ultrasound.

CONDITIONS

Official Title

Evaluation of Urinary Dysfunction in CANVAS Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old and more
  • Genetic confirmation of CANVAS (presence of pathogenic penta nucleotide expansion in both alleles of the replication factor C subunit 1(RFC1) gene or pathological penta nucleotide expansion in the heterozygous state associated with a truncating mutation on the second allele of the RFC1 gene)
  • Able to undergo renovesical ultrasound and urinary flow measurement
  • Having given informed consent in writing
  • Negative pregnancy test for people on childbearing age
  • Social security affiliated
Not Eligible

You will not qualify if you...

  • Presenting another urological pathology of base, not related to CANVAS
  • Having undergone a urological intervention within the 6 months preceding the screening visit
  • Presenting a condition that is incompatible with the proper conduct of the study as determined by the physician
  • Protected by law under guardianship or curators, or not able to participate in a clinical study pursuant to article L. 1121-16 of the French Public Health Code
  • Pregnant or breastfeeding women for women of childbearing age

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Nice University Hospital

Nice, Alpes Maritimes, France, 06000

Actively Recruiting

2

Montpellier University hospital

Montpellier, Hérault, France, 34000

Not Yet Recruiting

3

Lille University Hospital

Lille, Nord, France, 59000

Not Yet Recruiting

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Research Team

A

Andra EZARU

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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