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Completed

NCT Number: NCT05462171

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

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.

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Key information

Conditions

Erectile Dysfunction Ejaculatory Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Premature Ejaculation Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Department of Urology, Jagiellonian University

Krakow, Lesser Poland Voivodeship, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaires

Diagnostic 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).

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Bother of ED and PE in Poland

    Time frame: Through study completion, an average of 3 months

    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]).

  2. Prevalence of lower urinary tract symptoms in patients with PE and ED in Poland

    Time frame: Through study completion, an average of 3 months

    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)

  3. Prevalence of overactive bladder in patients with PE and ED in Poland

    Time frame: Through study completion, an average of 3 months

    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)

  4. Prevalence of depressive symptoms in patients with PE and ED in Poland

    Time frame: Through study completion, an average of 3 months

    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)

  5. Prevalence of insomnia in patients with PE and ED in Poland

    Time frame: Through study completion, an average of 3 months

    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)

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Acronym: ED POLAND

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 18, 2022
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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