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临床试验/NCT03803878
NCT03803878Unknown不适用

Medical, Epidemiologic, and Social Aspects of Aging (MESA) Urinary Incontinence Questionnaire: Translation and Validation of the Chinese Language Version in Women With Urgency-predominant Mixed Urinary Incontinence

Guang'anmen Hospital of China Academy of Chinese Medical Sciences1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
The criteria validity of MESA questionnaire compared with extended clinical evaluation in deciding predominant components of MUI.

研究概览

简要总结

The study is to translate the Medical, Epidemiologic, and Social aspects of Aging (MESA) urinary incontinence questionnaire into a Chinese language version and test the reliability and validity among women with urgency-predominant mixed urinary incontinence.

The hypothesis is that the Chinese language version of the MESA questionnaire will have adequate measurement properties (e.g. reliability and validity).

详细描述

Mixed urinary incontinence(MUI) is regarded as urgency-predominant when urgency incontinence episodes dominate over stress incontinence episodes, and vice versa. The treatment of MUI often begins with the most bothersome symptoms.

MESA questionnaire is a reliable and validated tool to evaluate the severity and predominance of stress or urgency urinary incontinence. At present, it hasn't been translated into a Chinese language version and validated.

The validation study of MESA questionnaire is embedded in a randomized controlled trial conducted among female patients, of which the data will be collected and analysed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The criteria validity of MESA questionnaire compared with extended clinical evaluation in deciding predominant components of MUI.

时间窗: screening and baseline periods

The extended clinical evaluation mainly includes physical examination, 3-day voiding diary, cough stress teat, urinalysis and residual urine volume by ultrasonography.

次要结局

  • The criteria validity of MESA questionnaire compared with International Consultation on Incontinence Questionnaire Short Form (ICIQ SF) in severity assessing among women with urgency-predominant mixed urinary incontinence.(baseline)
  • The criteria validity of MESA questionnaire compared with 3-day voiding diary in severity assessing among women with urgency-predominant mixed urinary incontinence.(baseline)
  • The test-retest reliability of MESA questionnaire(screening and baseline periods)
  • The responsiveness of MESA questionnaire(baseline, week 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Liu Zhishun

Principle investigator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

研究点 (1)

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