Study of Bladder-sphincter Symptoms in Functional Neurological Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Urinary Bladder Sphincter Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
A significant proportion of patients with functional neurological disorders (FND) report urinary, anorectal or genitosexual disorders. However, until now, no study has focused on bladder-sphincter disorders in patients with FND. The symptoms of this pathology are, therefore, not precisely characterized. Thus, the objective of this research is to specify if urinary, anorectal or sexual disorders can be observed in patients suffering from functional neurological disorders and to better describe them in order to propose better therapeutic options.
Detailed description
In this clinical study the investigators want to prospectively include all patients presenting to a neurology consultation or day hospital for management of a motor or sensory FND.The patients will first be evaluated for their sphincter functions by self questionnaires. For those where a vesico-sphincter complaint is demonstrated, a neuro-urological consultation will be proposed. A follow-up will then be done, if necessary, in neurology and neuro-urology.
Primary outcome measures
- presence of at least one bladder-sphincter disorder [Time frame: inclusion]
Secondary outcome measures (4)
- evaluate the nature of bladder and bowel disorders in patients with NFT [Time frame: inclusion]
- Assess the persistence of bladder and sphincter complaints in patients with NFTs [Time frame: 24months]
- Evaluate whether patients with significant vesico-sphincter complaints differ from patients without complaints, including demographic, traumatic, and NFT semiology. [Time frame: 24months]
- To assess whether the clinical and paraclinical patterns of bladder and sphincter disorders differ according to the type of NFT. [Time frame: 24months]
Eligibility criteria
Inclusion criteria
- Patient over 18 years of age
- Diagnosis of Functional Neurological Disorders according to DSM 5 criteria
- No neurological comorbidity that could account for the sphincter disorders
- Normal cerebral and spinal cord magnetic resonance imaging.
- Patient affiliated to a French social security system
- Patient informed and not objecting to participate in the study
Non inclusion Criteria :
- Presence of neurological comorbidity that can account for sphincter disorders (e.g. multiple sclerosis, chronic neuropathy, etc.)
- Pregnancy in progress
- Candidate for surgery or locoregional treatment
- Patient subject to legal protection measures.
- Patient under state medical assistance
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hospital Avicenne-Neurology — Bobigny
Identifiers
NCT: NCT05689866 · APHP221001