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CompletedNCT04121936Updated Jul 6, 2022

The Prevalence of Lower Urinary Tract Symptoms (LUTS) in Poland

An observational study in To Evaluate Lower Urinary Tract Symptoms (LUTS) in Poland, sponsored by Jagiellonian University. Completed at 1 site in Poland. Open to participants aged 40 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-06.

Sponsored by Jagiellonian University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
6,000
Ages
40 Years to 100 Years
Sex
All
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Study 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.

Read the detailed description

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.

This study will be conducted as a telephone survey with assessment of LUTS using a standardized protocol, which included the International Prostate Symptom Score (IPSS) and, for overactive bladder (OAB), the OAB-V8 questionnaire. Participants will be asked to rate how often they experienced individual LUTS and the degree of associated bother.

The study will be performed in a representative group of Polish population (n = 6,000) covering all geographic regions of Poland (defined by the Central Statistical Office of Poland).

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Conditions studied

  • To Evaluate Lower Urinary Tract Symptoms (LUTS) in Poland
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In context

Lower Urinary Tract Symptoms

406 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.

This study's enrollment of 6,000 is above the median of 179 across 132 observational studies indexed under Lower Urinary Tract Symptoms.

Browse Lower Urinary Tract Symptoms studies →

Lead sponsor

Jagiellonian University is the lead sponsor of 156 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Representative group of Polish population

Inclusion criteria

Age >40

Exclusion criteria

Exclusion Criteria:

Age \<40 Pregnancy Urinary tract infection in the past 4 weeks

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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
6,000 participants (actual)
Patient registry
No

Interventions

  • OtherThere will be no intervention

    There will be no intervention

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What researchers measure

Primary outcomes

  1. Prevalence of LUTS

    The prevalence of LUTS will be assessed using definitions of the International Continence Society (descriptive statistics).

    Time frame: Through study completion, an average of 3 months

  2. 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 \[score 5\]).

    Time frame: Through study completion, an average of 3 months

Secondary outcomes

  1. Prevalence of specific symptoms

    The prevalence of specific 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) \[Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21:167-178\]. Participants will be asked to rate how often they experienced individual LUTS during the past month. A Likert scale will be used with the following options: none (score 0), \<1 in 5 times (score 1), \<half the time (score 2), about half the time (score 3), \>half the time (score 4), or almost always (score 5).

    Time frame: Through study completion, an average of 3 months

  2. Symptom bother of specific symptoms

    The degree of associated bother of specific 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 \[score 5\]).

    Time frame: Through study completion, an average of 3 months

  3. Prevalence of OAB

    The prevalence of OAB will be assessed with the Overactive Bladder-Validated 8-question Screener (OAB-V8)questionnaire.

    Time frame: Through study completion, an average of 3 months

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Study locations

1 site
  • Department of Urology Jagiellonian University
    Krakow, Poland
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References and documents

Publications

  • 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. PubMed 33477665 ↗
  • 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. PubMed 33188254 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04121936
Lead sponsor
Jagiellonian University
Collaborators
Piotr Chlosta
Responsible party
Mikolaj Przydacz (Assistant, Jagiellonian University) — Principal investigator
First posted
Oct 10, 2019
Start date
Nov 11, 2019
Primary completion
Dec 31, 2019
Completion
Jun 1, 2021
Last update
Jul 6, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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