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

Completed

• Conditions: To Evaluate Lower Urinary Tract Symptoms (LUTS) in Poland

• Registration Number: NCT04121936
• Lead Sponsor: Jagiellonian University

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.

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 Timeline

• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-08
• Study First Posted: 2019-10-10
• Study Start: 2019-11-11
• Primary Completion: 2019-12-31
• Study Completion: 2021-06-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-04
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

Age >40

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of LUTS	Through study completion, an average of 3 months	The prevalence of LUTS will be assessed using definitions of the International Continence Society (descriptive statistics).
Symptom bother of LUTS	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 Outcome Measures

Name	Time	Method
Symptom bother of specific symptoms	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 \[score 5\]).
Prevalence of specific symptoms	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).
Prevalence of OAB	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.

Trial Locations

Locations (1)

Department of Urology Jagiellonian University; 🇵🇱 Krakow, Poland