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

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ClinicalTrials.gov Identifier: NCT04124874
Recruitment Status : Recruiting
First Posted : October 14, 2019
Last Update Posted : November 1, 2019
Sponsor:
Collaborator:
Piotr Chlosta
Information provided by (Responsible Party):
Mikolaj Przydacz, 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.

Condition or disease Intervention/treatment
To Evaluate Lower Urinary Tract Symptoms (LUTS) and Their Impact on Quality of Life in Night Workers 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.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Prevalence and Impact on Quality of Life of Lower Urinary Tract Symptoms (LUTS) in Night Workers
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: There will be no intervention
    There will be no intervention


Primary Outcome Measures :
  1. Prevalence of LUTS [ Time Frame: Through study completion, an average of 3 months ]
    The prevalence of LUTS will be assessed using definitions of the International Continence Society (descriptive statistics).

  2. Symptom bother of LUTS [ Time Frame: 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]).


Secondary Outcome Measures :
  1. Prevalence of specific lower urinary tract symptoms [ Time Frame: 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).

  2. Symptom bother of specific lower urinary tract symptoms [ Time Frame: 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]).

  3. Prevalence of OAB [ Time Frame: 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.

  4. Prevalence of depressive symptoms [ Time Frame: Through study completion, an average of 3 months ]
    The prevalence of depressive symptoms will be assessed with the PHQ-9 (Patient Health Questionnaire-9).

  5. Sleep quality [ Time Frame: Through study completion, an average of 3 months ]
    The sleep quality will be assessed with the Athen Insomnia Scale questionnaire.

  6. Work productivity [ Time Frame: Through study completion, an average of 3 months ]
    The work productivity will be assessed with the Work Productivity and Activity Impairment Questionnaire (WPAI).

  7. General quality of life [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes 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).
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124874


Contacts
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Contact: Mikolaj Przydacz, MD PhD PGDip 12 424-79-50 mikolaj.przydacz@mail.mcgill.ca

Locations
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Poland
Department of Urology Jagiellonian University Recruiting
Krakow, Poland
Contact: Mikolaj Przydacz, MD PhD PGDip    12 424-79-50    mikolaj.przydacz@mail.mcgill.ca   
Sponsors and Collaborators
Jagiellonian University
Piotr Chlosta

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Responsible Party: Mikolaj Przydacz, Assistant, Jagiellonian University
ClinicalTrials.gov Identifier: NCT04124874    
Other Study ID Numbers: 1072.6120.200.2019
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms