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NCT Number: NCT05689866

Study of Bladder-sphincter Symptoms in Functional Neurological Disorders

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Avicenne-Neurology

Bobigny, 93000, France

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. presence of at least one bladder-sphincter disorder

    Time frame: 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 outcomes

  1. evaluate the nature of bladder and bowel disorders in patients with NFT

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 24months

    Analysis of urodynamic assessment data

Study contacts

Contact information is provided by the study sponsor or research team.

Béatrice GARCIN, Dr

CONTACT

[email protected]

01 48 95 54 01

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: URO-TNF

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jan 19, 2023
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.