Clinical trial NCT05689866: Study of Bladder-sphincter Symptoms in Functional Neurological Disorders
Official title: Study of Bladder-sphincter Symptoms in Functional Neurological Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Bladder Sphincter Disorder
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to a neurology consultation or day hospital for management of a functional motor or sensory disorder.

Brief summary: 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.

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

Primary outcomes:
measure: presence of at least one bladder-sphincter disorder
timeFrame: inclusion
Secondary outcomes:
measure: evaluate the nature of bladder and bowel disorders in patients with NFT
timeFrame: inclusion
measure: Assess the persistence of bladder and sphincter complaints in patients with NFTs
timeFrame: 24months
measure: Evaluate whether patients with significant vesico-sphincter complaints differ from patients without complaints, including demographic, traumatic, and NFT semiology.
timeFrame: 24months
measure: To assess whether the clinical and paraclinical patterns of bladder and sphincter disorders differ according to the type of NFT.
timeFrame: 24months
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hospital Avicenne-Neurology
Study officials:
References: