To Evaluate Lower Urinary Tract Symptoms (LUTS) and Their Impact on Quality of Life in Night Workers Clinical Trial
Official title:
Prevalence and Impact on Quality of Life of Lower Urinary Tract Symptoms (LUTS) in Night Workers
| Verified date | March 2020 |
| Source | Jagiellonian University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The first large population-based study to evaluate lower urinary tract symptoms and their impact on quality of life in night workers.
| Status | Active, not recruiting |
| Enrollment | 10000 |
| Est. completion date | December 1, 2020 |
| Est. primary completion date | December 31, 2019 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Poland | Department of Urology Jagiellonian University | Krakow |
| Lead Sponsor | Collaborator |
|---|---|
| Jagiellonian University | Piotr Chlosta |
Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Sleep quality | The sleep quality will be assessed with the Athen Insomnia Scale questionnaire. | Through study completion, an average of 3 months | |
| Secondary | 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 | |
| Secondary | 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 |