NCT05462171

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

July 4, 2022

Last Update Submit

April 14, 2023

Conditions

Erectile DysfunctionPremature Ejaculation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Bother of ED and PE in Poland

    Through study completion, an average of 3 months

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

    Through study completion, an average of 3 months

  • Prevalence of overactive bladder in patients with PE and ED in Poland

    Through study completion, an average of 3 months

  • Prevalence of depressive symptoms in patients with PE and ED in Poland

    Through study completion, an average of 3 months

  • Prevalence of insomnia in patients with PE and ED in Poland

    Through study completion, an average of 3 months

Interventions

QuestionnairesDIAGNOSTIC_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).

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Age ≥18
  • A sufficient level of education to understand study procedures and be able to communicate with site personnel

You may not qualify if:

  • Age \<18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Jagiellonian University

Krakow, Lesser Poland Voivodeship, Poland

Location

Related Publications (1)

  • Przydacz M, Rajwa P, De Cillis S, Guillot-Tantay C, Herve F, Tienza Fernandez A, Tutolo M, Culha MG, Geretto P, Shenhar C, Miszczyk M, Chlosta P, Phe V, Osman N; European Association of Urology Young Academic Urologists (EAU YAU) Functional Urology Working Group. Lower Urinary Tract Symptoms Correlate with Erectile Dysfunction and Premature Ejaculation but Not with Men's Sexual Activity: Results from a Large Population-Representative Study. Healthcare (Basel). 2024 Jul 15;12(14):1408. doi: 10.3390/healthcare12141408.

    PMID: 39057551DERIVED

MeSH Terms

Conditions

Erectile DysfunctionPremature Ejaculation

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersEjaculatory Dysfunction

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD PhD DSc PGDip FEBU

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 18, 2022

Study Start

July 1, 2022

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations

PL(1)