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

To Evaluate Lower Urinary Tract Symptoms (LUTS) in Poland Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04121936
• Other study ID #: 1072.6120.160.2019
• Status: Completed
• Start date: November 11, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: July 2022
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6000
• Est. completion date: June 1, 2021
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

Inclusion Criteria:

Age >40 Exclusion Criteria: Age <40 Pregnancy Urinary tract infection in the past 4 weeks

Related Conditions & MeSH terms

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

Intervention

Other:
• There will be no intervention
There will be no intervention

Locations

Country	Name	City	State
Poland	Department of Urology Jagiellonian University	Krakow

Sponsors (2)

Lead Sponsor	Collaborator
Jagiellonian University	Piotr Chlosta

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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),	Through study completion, an average of 3 months
Secondary	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
Secondary	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