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临床试验/NCT04124874
NCT04124874Unknown不适用

Prevalence and Impact on Quality of Life of Lower Urinary Tract Symptoms (LUTS) in Night Workers

Jagiellonian University1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2019年10月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
10,000
试验地点
1
主要终点
Symptom bother of LUTS

研究概览

简要总结

The first large population-based study to evaluate lower urinary tract symptoms and their impact on quality of life in night workers.

详细描述

The first large population-based study to evaluate lower urinary tract symptoms (LUTS) and their impact on quality of life in night workers. The study objective is to assess the prevalence and bother of LUTS in the population of night workers.

This study will be conducted as a questionnaire survey with assessment of LUTS using a standardized protocol based on definitions by the International Continence Society (ICS). The International Prostate Symptom Score (IPSS), the Overactive Bladder- Validated 8-question Screener (OAB-V8), the Patient Health Questionnaire-9 (PHQ-9), the Athen Insomnia Scale, the Work Productivity and Activity Impairment Questionnaire (WPAI), the 12-Item Short Form Health Survey (SF-12) questionnaires will be included. Participants will be also asked to rate how often they experienced individual LUTS and the degree of associated bother.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • Night workers defined as any workers, who, during night time, work at least three hours of their daily working time as a normal course or who work at night at least 1/4 of their working time during the accounting period (definition by the Polish Labour Code).

排除标准

  • Non night workers Urinary tract infection in the past 4 weeks

结局指标

主要结局

Symptom bother of LUTS

时间窗: Through study completion, an average of 3 months

The degree of associated bother will be assessed using Likert scale (Likert scale: not at all \[score 0\], a little bit \[score 1\], somewhat \[score 2\], quite a bit \[score 3\], a great deal \[score 4\], or a very great deal \[score 5\]).

Prevalence of LUTS

时间窗: Through study completion, an average of 3 months

The prevalence of LUTS will be assessed using definitions of the International Continence Society (descriptive statistics).

次要结局

  • Work productivity(Through study completion, an average of 3 months)
  • Prevalence of specific lower urinary tract symptoms(Through study completion, an average of 3 months)
  • Sleep quality(Through study completion, an average of 3 months)
  • General quality of life(Through study completion, an average of 3 months)
  • Prevalence of depressive symptoms(Through study completion, an average of 3 months)
  • Symptom bother of specific lower urinary tract symptoms(Through study completion, an average of 3 months)
  • Prevalence of OAB(Through study completion, an average of 3 months)

研究者

发起方
Jagiellonian University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mikolaj Przydacz

Assistant

Jagiellonian University

研究点 (1)

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