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Completed

NCT Number: NCT04121936

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

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.

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Key information

Conditions

To Evaluate Lower Urinary Tract Symptoms (LUTS) in Poland

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Urology Jagiellonian University

Krakow, Poland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age >40

Exclusion criteria

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

Treatment and study plan

There will be no intervention

Other

There will be no intervention

Primary outcomes

  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 outcomes

  1. Prevalence of specific symptoms

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

    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).

  2. Symptom bother of specific symptoms

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

    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]).

  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.

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Collaborators

  • Piotr Chlosta

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2021
First posted
Oct 10, 2019
Registry last updated
Jul 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.