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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05462171
Other study ID # 1072.6120.331.2021
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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