NCT04124874

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

October 10, 2019

Last Update Submit

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

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

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

Study Sites (1)

Department of Urology Jagiellonian University

Krakow, Poland

Location

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

Locations