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

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

Study Overview

• Status: Completed
• Conditions: To Evaluate Lower Urinary Tract Symptoms (LUTS) in Poland
• Intervention / Treatment: Other: There will be no intervention

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).

• Study Type: Observational
• Enrollment (Actual): 6000

Contacts and Locations

Study Locations

• Poland
  • Krakow, Poland
    • Department of Urology Jagiellonian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Representative group of Polish population

Description

Inclusion Criteria:

Age >40

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Through study completion, an average of 3 months
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]).	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.	Through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Jagiellonian University
• Collaborators: Piotr Chlosta

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms
• Other Study ID Numbers: 1072.6120.160.2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No