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

Completed

• Conditions: Erectile Dysfunction; Premature Ejaculation

• Registration Number: NCT05462171
• Lead Sponsor: Jagiellonian University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-14
• Study First Posted: 2022-07-18
• Primary Completion: 2022-11-01
• Study Completion: 2022-12-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of PE in Poland	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)
Prevalence of ED in Poland	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)

Secondary Outcome Measures

Name	Time	Method
Bother of ED and PE in Poland	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 \[score 6\]).
Prevalence of lower urinary tract symptoms in patients with PE and ED in Poland	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)
Prevalence of insomnia in patients with PE and ED in Poland	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)
Prevalence of depressive symptoms in patients with PE and ED in Poland	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)
Prevalence of overactive bladder in patients with PE and ED in Poland	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)

Trial Locations

Locations (1)

Department of Urology, Jagiellonian University; 🇵🇱 Krakow, Malopolskie, Poland