To Evaluate Lower Urinary Tract Symptoms (LUTS) in PolandNCT04121936
The Prevalence of Lower Urinary Tract Symptoms (LUTS) in Poland
An observational study of To Evaluate Lower Urinary Tract Symptoms (LUTS) in Poland, run by Jagiellonian University at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 40 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- To Evaluate Lower Urinary Tract Symptoms (LUTS) in Poland
- How many people
- 6,000 participants
- Where
- 1 sitePoland
- Study dates
- 11 Nov 2019to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Representative group of Polish population
Who may be able to join
- Age >40
Who cannot join
- Age <40 Pregnancy Urinary tract infection in the past 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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).
- Being tested
- There will be no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There will be no interventionOther
There will be no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of LUTS
The prevalence of LUTS will be assessed using definitions of the International Continence Society (descriptive statistics).
Measured: 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]).
Measured: Through study completion, an average of 3 months
Secondary outcomes (3)
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).
Measured: 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]).
Measured: 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.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start11 Nov 2019
- Primary completion31 Dec 2019
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for To Evaluate Lower Urinary Tract Symptoms (LUTS) in PolandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 6,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Collaborators
- Piotr Chlosta
- Responsible party
- Principal investigator, Mikolaj Przydacz, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121936
- Sponsor's protocol ID
- 1072.6120.160.2019
- Status last verified
- Jul 2022
- First submitted
- 7 Oct 2019
- Last updated
- 6 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 33477665Przydacz 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Lower Urinary Tract Symptoms (LUTS) in Poland: Epidemiology of LUTS (Poland LUTS) Study
- ClinicalTrials.gov ID
- NCT04121936
- Acronym / sponsor ID
- 1072.6120.160.2019
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Collaborators
- Piotr Chlosta
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Representative group of Polish population
Key inclusion criteria (1 listed)
- Age >40
Key exclusion criteria (1 listed)
- Age <40 Pregnancy Urinary tract infection in the past 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There will be no interventionThere will be no intervention | Other | – |
Primary outcome
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).
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]).
3 secondary outcomes
Prevalence of specific symptoms
Time frame: Through study completion, an average of 3 months
Symptom bother of specific symptoms
Time frame: Through study completion, an average of 3 months
Prevalence of OAB
Time frame: Through study completion, an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Derived from this study: PubMed 33477665Przydacz 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.
- Derived from this study: PubMed 33188254Przydacz 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Evaluate Lower Urinary Tract Symptoms (LUTS) in Poland, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of LUTS (time frame: Through study completion, an average of 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04121936, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.