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临床试验/NCT06226831
NCT06226831招募中不适用

Onset of Lower Urinary Tract Symptoms in Multiple Sclerosis Patients

University Hospital Ostrava1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,500
试验地点
1
主要终点
LUTS onset

研究概览

简要总结

Retrospective, non-interventional case-control study, the patients were asked about their first lower-urinary tract symptoms and the date of their onset, using a structured interview. The information was matched with the medical records.

详细描述

This retrospective non-interventional case-control study will be conducted at a single tertiary referral Multidisciplinary Centre for Diagnostics and Treatment of MS at the University Hospital, Ostrava, Czech Republic. The study will be performed per the Declaration of Helsinki, World Health Organization. The study protocol has been approved by the Ethics Committee of University Hospital Ostrava, Nr.289/19.

The database of the Center includes medical records of all consecutive patients, who have visited the center at least once, starting from 1996 until the present day. Based on the inclusion criteria of proven multiple sclerosis (MS) diagnosis and the current age over 18 years, the initial database search identified eligible 2348 individuals. During the routine follow-up visit of the patients at the Center, a structured in-person interview led by a physician will be performed.

The data from this interview will be cross-checked with the medical records. In addition to standard demographic variables, the following data will be obtained:

Age 1 - Age at the onset of the first symptoms of MS Age 2 - Age at the time of diagnosis of MS Age 3 - Age at the time of data collection MS course - patients with a primary progressive, secondary progressive, or progressive relapsing disease at the time of data collection will be included in the group "Progressive MS course". The "Relapsing-remitting MS course" group will include patients who had a relapsing-remitting disease and those with isolated clinical symptoms at the time of data collection.

CPS - The "CPS yes" group will include patients who experienced cerebellar and/or pyramidal symptoms (CPS) as the first manifestation of MS. Patients with other first manifestations, such as optic neuritis, sensory disturbances, etc., will be included in the "CPS no" group.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of multiple sclerosis
  • adult patients
  • signed informed consent

排除标准

  • 未提供

结局指标

主要结局

LUTS onset

时间窗: 1 hour of structured interview

The time of LUTS onset in relation to the diagnosis of MS diagnosis (before or after) will be observed in months, during the structured interviews with the study subjects.

次要结局

  • Course of disease (clinical examination)(5 years)
  • Course of disease (EDSS scale)(5 years)

研究者

发起方
University Hospital Ostrava
申办方类型
Other
责任方
Sponsor

研究点 (1)

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