Clinical trial NCT04124874: Prevalence and Impact on Quality of Life of Lower Urinary Tract Symptoms (LUTS) in Night Workers
Official title: Prevalence and Impact on Quality of Life of Lower Urinary Tract Symptoms (LUTS) in Night Workers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: To Evaluate Lower Urinary Tract Symptoms (LUTS) and Their Impact on Quality of Life in Night Workers
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
Collaborators: name: Piotr Chlosta
First posted: 2019-10-14
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of LUTS
timeFrame: Through study completion, an average of 3 months
measure: Symptom bother of LUTS
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Prevalence of specific lower urinary tract symptoms
timeFrame: Through study completion, an average of 3 months
measure: Symptom bother of specific lower urinary tract symptoms
timeFrame: Through study completion, an average of 3 months
measure: Prevalence of OAB
timeFrame: Through study completion, an average of 3 months
measure: Prevalence of depressive symptoms
timeFrame: Through study completion, an average of 3 months
measure: Sleep quality
timeFrame: Through study completion, an average of 3 months
measure: Work productivity
timeFrame: Through study completion, an average of 3 months
measure: General quality of life
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Department of Urology Jagiellonian University
Study officials:
References: