Prevalence and Impact on Quality of Life of Lower Urinary Tract Symptoms (LUTS) in Night Workers
1 other identifier
observational
10,000
1 country
1
Brief Summary
The first large population-based study to evaluate lower urinary tract symptoms and their impact on quality of life in night workers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2019
CompletedFirst Posted
Study publicly available on registry
October 14, 2019
CompletedStudy Start
First participant enrolled
October 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMarch 30, 2020
March 1, 2020
3 months
October 10, 2019
March 27, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
Prevalence of specific lower urinary tract 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
Prevalence of depressive symptoms
Through study completion, an average of 3 months
Sleep quality
Through study completion, an average of 3 months
- +2 more secondary outcomes
Interventions
There will be no intervention
Eligibility 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).
You may qualify if:
- 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).
You may not qualify if:
- Non night workers Urinary tract infection in the past 4 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jagiellonian Universitylead
- Piotr Chlostacollaborator
Study Sites (1)
Department of Urology Jagiellonian University
Krakow, Poland
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant
Study Record Dates
First Submitted
October 10, 2019
First Posted
October 14, 2019
Study Start
October 15, 2019
Primary Completion
December 31, 2019
Study Completion
December 1, 2020
Last Updated
March 30, 2020
Record last verified: 2020-03