To Evaluate Lower Urinary Tract Symptoms (LUTS) and Their Impact on Quality of Life in Night WorkersNCT04124874
Prevalence and Impact on Quality of Life of Lower Urinary Tract Symptoms (LUTS) in Night Workers
An observational study of To Evaluate Lower Urinary Tract Symptoms (LUTS) and Their Impact on Quality of Life in Night Workers, run by Jagiellonian University at 1 site in Poland.
Trial summary
The first large population-based study to evaluate lower urinary tract symptoms and their impact on quality of life in night workers. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- To Evaluate Lower Urinary Tract Symptoms (LUTS) and Their Impact on Quality of Life in Night Workers
- How many people
- 10,000 participants
- Where
- 1 sitePoland
- Study dates
- 15 Oct 2019to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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).
Who may be able to join
- 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).
Who cannot join
- Non night workers Urinary tract infection in the past 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
The first large population-based study to evaluate lower urinary tract symptoms and their impact on quality of life in night workers.
Read the 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.
- Conditions
- To Evaluate Lower Urinary Tract Symptoms (LUTS) and Their Impact on Quality of Life in Night Workers
- Being tested
- There will be no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There will be no interventionOther
There will be no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of LUTS
The prevalence of LUTS will be assessed using definitions of the International Continence Society (descriptive statistics).
Measured: 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]).
Measured: Through study completion, an average of 3 months
Secondary outcomes (7)
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).
Measured: 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]).
Measured: 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.
Measured: 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).
Measured: Through study completion, an average of 3 months
Sleep quality
The sleep quality will be assessed with the Athen Insomnia Scale questionnaire.
Measured: 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).
Measured: 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).
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start15 Oct 2019
- Primary completion31 Dec 2019
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate Lower Urinary Tract Symptoms (LUTS) and Their Impact on Quality of Life in Night WorkersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Collaborators
- Piotr Chlosta
- Responsible party
- Principal investigator, Mikolaj Przydacz, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124874
- Sponsor's protocol ID
- 1072.6120.200.2019
- Status last verified
- Mar 2020
- First submitted
- 10 Oct 2019
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Impact on Quality of Life of Lower Urinary Tract Symptoms (LUTS) in Night Workers
- ClinicalTrials.gov ID
- NCT04124874
- Acronym / sponsor ID
- 1072.6120.200.2019
- Conditions
- To Evaluate Lower Urinary Tract Symptoms (LUTS) and Their Impact on Quality of Life in Night Workers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Collaborators
- Piotr Chlosta
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Non night workers Urinary tract infection in the past 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There will be no interventionThere will be no intervention | Other | – |
Primary outcome
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).
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]).
7 secondary outcomes
Prevalence of specific lower urinary tract symptoms
Time frame: Through study completion, an average of 3 months
Symptom bother of specific lower urinary tract symptoms
Time frame: Through study completion, an average of 3 months
Prevalence of OAB
Time frame: Through study completion, an average of 3 months
Prevalence of depressive symptoms
Time frame: Through study completion, an average of 3 months
Sleep quality
Time frame: Through study completion, an average of 3 months
Work productivity
Time frame: Through study completion, an average of 3 months
General quality of life
Time frame: Through study completion, an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Evaluate Lower Urinary Tract Symptoms (LUTS) and Their Impact on Quality of Life in Night Workers, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of LUTS (time frame: Through study completion, an average of 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.