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

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction; Premature Ejaculation
• Intervention / Treatment: Diagnostic test: Questionnaires

• Study Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• Poland
  • Malopolskie
    • Krakow, Malopolskie, Poland
      • Department of Urology, Jagiellonian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

A representative group of male Polish population (n=3000).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pregnancy Complications; Obstetric Labor Complications; Sexual Dysfunctions, Psychological; Obstetric Labor, Premature; Sexual Dysfunction, Physiological; Premature Birth; Erectile Dysfunction; Premature Ejaculation
• Other Study ID Numbers: 1072.6120.331.2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No