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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05689866
Collaborator
(none)
150
46

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study of Bladder-sphincter Symptoms in Functional Neurological Disorders
    Anticipated Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. 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

    4. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT05689866
    Other Study ID Numbers:
    • APHP221001
    First Posted:
    Jan 19, 2023
    Last Update Posted:
    Jan 19, 2023
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 19, 2023