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

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

Study Overview

• Status: Unknown
• Conditions: To Evaluate Lower Urinary Tract Symptoms (LUTS) and Their Impact on Quality of Life in Night Workers
• Intervention / Treatment: Other: There will be no intervention

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 Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• Poland
  • Krakow, Poland
    • Department of Urology Jagiellonian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of LUTS	The prevalence of LUTS will be assessed using definitions of the International Continence Society (descriptive statistics).	Through study completion, an average of 3 months
Symptom bother of LUTS	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]).	Through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of specific lower urinary tract symptoms	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).	Through study completion, an average of 3 months
Symptom bother of specific lower urinary tract symptoms	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]).	Through study completion, an average of 3 months
Prevalence of OAB	The prevalence of OAB will be assessed with the Overactive Bladder-Validated 8-question Screener (OAB- V8) questionnaire.	Through study completion, an average of 3 months
Prevalence of depressive symptoms	The prevalence of depressive symptoms will be assessed with the PHQ-9 (Patient Health Questionnaire-9).	Through study completion, an average of 3 months
Sleep quality	The sleep quality will be assessed with the Athen Insomnia Scale questionnaire.	Through study completion, an average of 3 months
Work productivity	The work productivity will be assessed with the Work Productivity and Activity Impairment Questionnaire (WPAI).	Through study completion, an average of 3 months
General quality of life	The general quality of life will be assessed with the 12-Item Short Form Health Survey (SF-12).	Through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Jagiellonian University
• Collaborators: Piotr Chlosta

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 27, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms
• Other Study ID Numbers: 1072.6120.200.2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No