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Study of Bladder-sphincter Symptoms in Functional Neurological Disorders

Study of Bladder-sphincter Symptoms in Functional Neurological Disorders

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05689866
Acronym
URO-TNF
Enrollment
150
Registered
2023-01-19
Start date
2023-03-08
Completion date
2026-12-31
Last updated
2023-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Bladder Sphincter 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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
presence of at least one bladder-sphincter disorderinclusionThis 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

MeasureTime frameDescription
evaluate the nature of bladder and bowel disorders in patients with NFTinclusionthe 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 NFTs24monthsthe 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.24monthscomparison 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.24monthsAnalysis of urodynamic assessment data

Countries

France

Contacts

Primary ContactBéatrice GARCIN, Dr
beatrice.garcin@aphp.fr01 48 95 54 01

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026