Evaluating urinary dysfunction in patients with CANVAS
Evaluation of Urinary Dysfunction in CANVAS Patients
This study is trying to see how common urinary problems are in people with CANVAS and if these issues are linked to their neurological symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 3 sites (Nice, Alpes Maritimes and 2 other locations) |
| Trial ID | NCT06817707 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the prevalence of urinary symptoms in patients diagnosed with Cerebellar Ataxia, Neuropathy, and Vestibular Areflexia Syndrome (CANVAS). It will evaluate the incidence of urinary dysfunction and potential complications in the urinary system among these patients. The study will involve detailed neurological examinations, laboratory tests for renal function, dysautonomia assessments, and the use of urinary function questionnaires to analyze the relationship between neurological deficits and urinary symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with genetically confirmed CANVAS.
Not a fit: Patients with unrelated urological conditions or those who have undergone recent urological interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of urinary dysfunction in CANVAS patients, improving their quality of life.
How similar studies have performed: While the specific evaluation of urinary dysfunction in CANVAS is novel, similar studies have shown that understanding comorbidities in neurological conditions can lead to improved patient care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Nice, Alpes Maritimes and 2 other locations
- Nice University Hospital — Nice, Alpes Maritimes, France (Recruiting)
- Montpellier University hospital — Montpellier, Hérault, France (Not_yet_recruiting)
- Lille University Hospital — Lille, Nord, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Andra EZARU
- Email: ezaru.a@chu-nice.fr
- Phone: 04 92 03 96 55
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.