Study of Bladder-sphincter Symptoms in Functional Neurological Disorders

Recruiting

• Conditions: Urinary Bladder Sphincter Disorder

• Registration Number: NCT05689866
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2023-01-16
• Study First Posted: 2023-01-19
• Study Start: 2023-03-08
• Status Verified: 2023-06
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-23
• Primary Completion: 2024-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
presence of at least one bladder-sphincter disorder	inclusion	This primary endpoint will be measured by the score of the questionnairies which will define the presence of a vesicosphincter disorder (USP), anorectal disorder (Kess and Wexner) or sexual genital disorder (FSFI/IIEF5)

Secondary Outcome Measures

Name	Time	Method
evaluate the nature of bladder and bowel disorders in patients with NFT	inclusion	the score of the different questionnairies vesicosphincter disorder (USP), anorectal disorder (Kess and Wexner) or sexual genital disorder (FSFI/IIEF5) that will define the presence of a bladder symptoms
Assess the persistence of bladder and sphincter complaints in patients with NFTs	24months	the score of the questionnairies vesicosphincter disorder (USP), anorectal disorder (Kess and Wexner) or sexual genital disorder (FSFI/IIEF5) that will define the presence of a bladder symptoms
Evaluate whether patients with significant vesico-sphincter complaints differ from patients without complaints, including demographic, traumatic, and NFT semiology.	24months	comparison of the characteristics of patients on the vesico-sphincter level
To assess whether the clinical and paraclinical patterns of bladder and sphincter disorders differ according to the type of NFT.	24months	Analysis of urodynamic assessment data

Trial Locations

Locations (1)

Hospital Avicenne-Neurology; 🇫🇷 Bobigny, France