Study of Bladder-sphincter Symptoms in Functional Neurological Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- presence of at least one bladder-sphincter disorder
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
presence of at least one bladder-sphincter disorder
时间窗: 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)
次要结局
- evaluate the nature of bladder and bowel disorders in patients with NFT(inclusion)
- Assess the persistence of bladder and sphincter complaints in patients with NFTs(24months)
- Evaluate whether patients with significant vesico-sphincter complaints differ from patients without complaints, including demographic, traumatic, and NFT semiology.(24months)
- To assess whether the clinical and paraclinical patterns of bladder and sphincter disorders differ according to the type of NFT.(24months)