Erectile DysfunctionED POLANDNCT05462171
The Prevalence of Erectile Dysfunction (ED) and Premature Ejaculation (PE) in Poland
An observational study of Erectile Dysfunction and Premature Ejaculation, run by Jagiellonian University at 1 site in Poland.
Trial summary
The first large population-based study to evaluate erectile dysfunction (ED) and premature ejaculation (PE) in Poland. The study objective is to assess the prevalence and bother of ED and PE in the representative group of male population of Poland. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction, Premature Ejaculation
- What is being tested?
- Questionnaires
- How many people
- 3,000 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2022to 1 Dec 2022
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A representative group of male Polish population (n=3000).
Who may be able to join
- Age ≥18
- A sufficient level of education to understand study procedures and be able to communicate with site personnel
Who cannot join
- Age <18
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Urology, Jagiellonian University
Krakow, Lesser Poland Voivodeship
About this study
The first large population-based study to evaluate erectile dysfunction (ED) and premature ejaculation (PE) in Poland. The study objective is to assess the prevalence and bother of ED and PE in the representative group of male population of Poland.
- Conditions
- Erectile Dysfunction, Premature Ejaculation
- Being tested
- Questionnaires
- Medical subject headings
- Erectile Dysfunction, Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesDiagnostic test
Participants will be asked to complete validated questionnaires (the five-item International Index of Erectile Function - IIEF-5, Premature Ejaculation Diagnostic Tool - PEDT, International Prostate Symptom Score - IPSS, Overactive Bladder - Validated 8-question Screener - OAB-V8, Hospital Anxiety and Depression Scale - HADS, Athens Insomnia Scale - AIS).
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of ED in Poland
The prevalence of ED will be assessed using the five-item International Index of Erectile Function (IIEF-5; the lowest score 5; the highest score 25; the lower the score, the greater the severity of the symptoms)
Measured: Through study completion, an average of 3 months
Prevalence of PE in Poland
The prevalence of PE will be assessed using the Premature Ejaculation Diagnostic Tool (PEDT; the lowest score 0; the highest score 20; the lower the score, the lower the severity of the symptoms)
Measured: Through study completion, an average of 3 months
Secondary outcomes (5)
Bother of ED and PE in Poland
The degree of associated bother will be assessed using Likert scale (Likert scale: delighted [score 0], pleased [score 1], mostly satisfied [score 2], mixed [score 3], mostly dissatisfied [score 4], unhappy [score 5], or terrible [score 6]).
Measured: Through study completion, an average of 3 months
Prevalence of lower urinary tract symptoms in patients with PE and ED in Poland
The prevalence of lower urinary tract symptoms will be assessed with the International Prostate Symptom Score (IPSS; the lowest score 0, the highest score 35, the lower the score, the lower the severity of the symptoms)
Measured: Through study completion, an average of 3 months
Prevalence of overactive bladder in patients with PE and ED in Poland
The prevalence of overactive bladder will be assessed with the Overactive Bladder - Validated 8-question Screener (OAB-V8; the lowest score 0; the highest score 40; the lower the score, the lower the severity of the symptoms)
Measured: Through study completion, an average of 3 months
Prevalence of depressive symptoms in patients with PE and ED in Poland
The prevalence of depressive symptoms will be assessed with the Hospital Anxiety and Depression Scale (HADS; the lowest score 0; the highest score 48; the lower the score, the lower the severity of the symptoms)
Measured: Through study completion, an average of 3 months
Prevalence of insomnia in patients with PE and ED in Poland
The prevalence of insomnia will be assessed with the Athens Insomnia Scale (AIS; the lowest score 0; the highest score 24; the lower the score, the lower the severity of the symptoms)
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 posted18 Jul 2022
- Study start1 Jul 2022
- Primary completion1 Nov 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikolaj Przydacz, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462171
- Sponsor's protocol ID
- 1072.6120.331.2021
- Acronym
- ED POLAND
- Status last verified
- Apr 2023
- First submitted
- 4 Jul 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Przydacz M, Rajwa P, De Cillis S, Guillot-Tantay C, Herve F, Tienza Fernandez A, Tutolo M, Culha MG, Geretto P, Shenhar C, Miszczyk M, Chlosta P, Phe V, Osman N; European Association of Urology Young Academic Urologists (EAU YAU) Functional Urology Working Group. Lower Urinary Tract Symptoms Correlate with Erectile Dysfunction and Premature Ejaculation but Not with Men's Sexual Activity: Results from a Large Population-Representative Study. Healthcare (Basel). 2024 Jul 15;12(14):1408. doi: 10.3390/healthcare12141408.
PubMed 39057551
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Erectile Dysfunction (ED) and Premature Ejaculation (PE) in Poland
- ClinicalTrials.gov ID
- NCT05462171
- Acronym / sponsor ID
- ED POLAND / 1072.6120.331.2021
- Conditions
- Erectile Dysfunction, Premature Ejaculation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 18 Jul 2022 (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 erectile dysfunction (ED) and premature ejaculation (PE) in Poland. The study objective is to assess the prevalence and bother of ED and PE in the representative group of male population of Poland.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A representative group of male Polish population (n=3000).
Key inclusion criteria (2 listed)
- Age ≥18
- A sufficient level of education to understand study procedures and be able to communicate with site personnel
Key exclusion criteria (1 listed)
- Age <18
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 |
|---|---|---|
| QuestionnairesParticipants will be asked to complete validated questionnaires (the five-item International Index of Erectile Function - IIEF-5, Premature Ejaculation Diagnostic Tool - PEDT, International Prostate Symptom Score - IPSS, Overactive Bladder - Validated 8-question Screener - OAB-V8, Hospital Anxiety and Depression Scale - HADS, Athens Insomnia Scale - AIS). | Diagnostic test | – |
Primary outcome
Prevalence of ED in Poland
Time frame: Through study completion, an average of 3 months
The prevalence of ED will be assessed using the five-item International Index of Erectile Function (IIEF-5; the lowest score 5; the highest score 25; the lower the score, the greater the severity of the symptoms)
Prevalence of PE in Poland
Time frame: Through study completion, an average of 3 months
The prevalence of PE will be assessed using the Premature Ejaculation Diagnostic Tool (PEDT; the lowest score 0; the highest score 20; the lower the score, the lower the severity of the symptoms)
5 secondary outcomes
Bother of ED and PE in Poland
Time frame: Through study completion, an average of 3 months
Prevalence of lower urinary tract symptoms in patients with PE and ED in Poland
Time frame: Through study completion, an average of 3 months
Prevalence of overactive bladder in patients with PE and ED in Poland
Time frame: Through study completion, an average of 3 months
Prevalence of depressive symptoms in patients with PE and ED in Poland
Time frame: Through study completion, an average of 3 months
Prevalence of insomnia in patients with PE and ED in Poland
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 18 Apr 2023.
- Derived from this study: PubMed 39057551Przydacz M, Rajwa P, De Cillis S, Guillot-Tantay C, Herve F, Tienza Fernandez A, Tutolo M, Culha MG, Geretto P, Shenhar C, Miszczyk M, Chlosta P, Phe V, Osman N; European Association of Urology Young Academic Urologists (EAU YAU) Functional Urology Working Group. Lower Urinary Tract Symptoms Correlate with Erectile Dysfunction and Premature Ejaculation but Not with Men's Sexual Activity: Results from a Large Population-Representative Study. Healthcare (Basel). 2024 Jul 15;12(14):1408. doi: 10.3390/healthcare12141408.
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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 Erectile Dysfunction and Premature Ejaculation, 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 2 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 18 Apr 2023. 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 ED in Poland (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 NCT05462171, which also lists 1 linked publication.
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 18 Apr 2023; AzTrials last refreshed its copy on 26 Oct 2026.