The Prevalence of Erectile Dysfunction (ED) and Premature Ejaculation (PE) in Poland

Study Overview
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Brief Summary
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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.

Official Title
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The Prevalence of Erectile Dysfunction (ED) and Premature Ejaculation (PE) in Poland

Conditions
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Erectile Dysfunction, Premature Ejaculation

Intervention / Treatment
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* Diagnostic Test: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 A sufficient level of education to understand study procedures and be able to communicate with site personnel Exclusion Criteria: • Age <18

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Questionnaires|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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | Through study completion, an average of 3 months | 

Secondary Outcome Measures

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