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

Erectile Dysfunction Clinical Trial

— ED POLAND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05462171
• Other study ID #: 1072.6120.331.2021
• Status: Completed
• Start date: July 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2023
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: December 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Premature Birth
• Premature Ejaculation

Intervention

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).

Locations

Country	Name	City	State
Poland	Department of Urology, Jagiellonian University	Krakow	Malopolskie

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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