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

• Conditions: To Evaluate Lower Urinary Tract Symptoms (LUTS) and Their Impact on Quality of Life in Night Workers

• Registration Number: NCT04124874
• Lead Sponsor: Jagiellonian University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-10
• Study First Posted: 2019-10-14
• Study Start: 2019-10-15
• Primary Completion: 2019-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-27
• Last Update Posted: 2020-03-30
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

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).

Exclusion Criteria

Non night workers Urinary tract infection in the past 4 weeks

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom bother of LUTS	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	Through study completion, an average of 3 months	The prevalence of LUTS will be assessed using definitions of the International Continence Society (descriptive statistics).

Secondary Outcome Measures

Name	Time	Method
Work productivity	Through study completion, an average of 3 months	The work productivity will be assessed with the Work Productivity and Activity Impairment Questionnaire (WPAI).
Prevalence of specific lower urinary tract symptoms	Through study completion, an average of 3 months	The prevalence of specific lower urinary tract symptoms will be assessed using a standardised protocol based on the definitions provided by the International Continence Society (i.e. storage symptoms, voiding symptoms and post-micturition symptoms).
Sleep quality	Through study completion, an average of 3 months	The sleep quality will be assessed with the Athen Insomnia Scale questionnaire.
General quality of life	Through study completion, an average of 3 months	The general quality of life will be assessed with the 12-Item Short Form Health Survey (SF-12).
Prevalence of depressive symptoms	Through study completion, an average of 3 months	The prevalence of depressive symptoms will be assessed with the PHQ-9 (Patient Health Questionnaire-9).
Symptom bother of specific lower urinary tract symptoms	Through study completion, an average of 3 months	The degree of associated bother of specific lower urinary tract symptoms 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 OAB	Through study completion, an average of 3 months	The prevalence of OAB will be assessed with the Overactive Bladder-Validated 8-question Screener (OAB- V8) questionnaire.

Trial Locations

Locations (1)

Department of Urology Jagiellonian University; 🇵🇱 Krakow, Poland