NCT04121936

Brief Summary

The first large population-based study to evaluate lower urinary tract symptoms (LUTS) in Poland. The study objective is to assess the prevalence and bother of LUTS in the population aged ≥40 years in Poland.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

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 7, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 11, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

July 6, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

October 7, 2019

Last Update Submit

July 4, 2022

Conditions

To Evaluate Lower Urinary Tract Symptoms (LUTS) in Poland

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 (3)

  • Prevalence of specific symptoms

    Through study completion, an average of 3 months

  • Symptom bother of specific symptoms

    Through study completion, an average of 3 months

  • Prevalence of OAB

    Through study completion, an average of 3 months

Interventions

There will be no interventionOTHER

There will be no intervention

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Representative group of Polish population

You may qualify if:

  • Age \>40

You may not qualify if:

  • Age \<40 Pregnancy 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

Related Publications (2)

  • Przydacz M, Dudek P, Golabek T, Chlosta P. Relationship between Lower Urinary Tract Symptoms and Treatment-Related Behavior in an Eastern European Country: Findings from the LUTS POLAND Study. Int J Environ Res Public Health. 2021 Jan 18;18(2):785. doi: 10.3390/ijerph18020785.

    PMID: 33477665DERIVED

  • Przydacz M, Golabek T, Dudek P, Lipinski M, Chlosta P. Prevalence and bother of lower urinary tract symptoms and overactive bladder in Poland, an Eastern European Study. Sci Rep. 2020 Nov 13;10(1):19819. doi: 10.1038/s41598-020-76846-0.

    PMID: 33188254DERIVED

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 7, 2019

First Posted

October 10, 2019

Study Start

November 11, 2019

Primary Completion

December 31, 2019

Study Completion

June 1, 2021

Last Updated

July 6, 2022

Record last verified: 2022-07

Locations

PL(1)