Study of Bladder-sphincter Symptoms in Functional Neurological Disorders (URO-TNF)

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Bladder Sphincter Disorder

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Béatrice GARCIN, Dr; Phone Number: 01 48 95 54 01; Email: beatrice.garcin@aphp.fr

Study Locations

• France
  • Bobigny, France, 93000
    • Recruiting
    • Hospital Avicenne-Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
presence of at least one bladder-sphincter disorder	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)	inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate the nature of bladder and bowel disorders in patients with NFT	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	inclusion
Assess the persistence of bladder and sphincter complaints in patients with NFTs	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	24months
Evaluate whether patients with significant vesico-sphincter complaints differ from patients without complaints, including demographic, traumatic, and NFT semiology.	comparison of the characteristics of patients on the vesico-sphincter level	24months
To assess whether the clinical and paraclinical patterns of bladder and sphincter disorders differ according to the type of NFT.	Analysis of urodynamic assessment data	24months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Somatoform Disorders; Histrionic Personality Disorder; Nervous System Diseases; Conversion Disorder; Hysteria
• Other Study ID Numbers: APHP221001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No