Actively Recruiting
Evaluation of Urinary Dysfunction in Patients with CANVAS
Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-03-26
40
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying urinary symptoms in patients diagnosed with Cerebellar Ataxia, Neuropathy, Vestibular Areflexia Syndrome (CANVAS). This condition affects the nervous system and is known to cause urinary system problems in about one third of patients. The main goal is to find out how common these urinary symptoms are and to explore possible complications in both the upper and lower urinary systems. They also want to see how urinary problems relate to the severity of neurological symptoms and signs of autonomic nervous system dysfunction. The study involves a detailed neurological exam using the SARA scale, laboratory tests for kidney function, autonomic nervous system tests including Sudoscan and orthostatic hypotension checks, urinary function questionnaires, urodynamic tests, and ultrasound of the urinary system. These assessments will help characterize the types and severity of urinary dysfunctions and their impact on quality of life. The study collects data at the start and follows participants for up to six months to evaluate biological and structural complications. Participants will undergo various exams and complete questionnaires to monitor urinary and neurological health. Researchers will evaluate urinary flow and autonomic nervous system symptoms, analyzing their relationships with neurological severity. The main outcome is to assess the prevalence of urinary dysfunctions confirmed genetically as CANVAS at the time of inclusion. Safety and study progress are monitored throughout, with the study expected to end in March 2027.
CONDITIONS
Brief Title
Evaluation of Urinary Dysfunction in CANVAS Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old and above
- Genetic confirmation of CANVAS with specific RFC1 gene mutations
- Ability to undergo renovesical ultrasound and urinary flow measurement
- Provided written informed consent
- Negative pregnancy test for people of childbearing age
- Affiliated with social security
You will not qualify if you...
- Having another urological condition not related to CANVAS
- Urological intervention within 6 months before screening
- Any condition deemed incompatible with study participation by a physician
- Under legal guardianship or unable to participate under French Public Health Code
- Pregnant or breastfeeding women of childbearing age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At inclusion
Participants undergo evaluations to assess urinary dysfunction using neurologic exams, questionnaires, urinary diary reports, biologic analysis, Sudoscan, and urological exams.
1 visit (in-person)
Duration - Within 6 months after inclusion
Participants are monitored for structural complications in the upper urinary tract and urinary flow malfunction over 6 months following inclusion.
Follow-up assessments during this period
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
Research Team
A
Andra EZARU
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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