Onset of Lower Urinary Tract Symptoms in Multiple Sclerosis Patients
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
- 否
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)
