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CompletedNCT05462171ED POLANDUpdated Apr 18, 2023

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

An observational study in Erectile Dysfunction and Premature Ejaculation, sponsored by Jagiellonian University. Completed at 1 site in Poland. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-18.

Sponsored by Jagiellonian University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
3,000
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Erectile Dysfunction
  • Premature Ejaculation
03

In context

Erectile Dysfunction

701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.

This study's enrollment of 3,000 is above the median of 130 across 125 observational studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Jagiellonian University is the lead sponsor of 161 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Age \<18
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
3,000 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testQuestionnaires

    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).

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What researchers measure

Primary outcomes

  1. 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)

    Time frame: Through study completion, an average of 3 months

  2. 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)

    Time frame: Through study completion, an average of 3 months

Secondary outcomes

  1. 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 \[score 6\]).

    Time frame: Through study completion, an average of 3 months

  2. 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)

    Time frame: Through study completion, an average of 3 months

  3. 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)

    Time frame: Through study completion, an average of 3 months

  4. 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)

    Time frame: Through study completion, an average of 3 months

  5. 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)

    Time frame: Through study completion, an average of 3 months

07

Study locations

1 site
  • Department of Urology, Jagiellonian University
    Krakow, Malopolskie, Poland
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2022 to primary completion in Nov 2022, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 4, 2022
First posted
Jul 18, 2022
StartActual
Jul 1, 2022
Primary completionActual
Nov 1, 2022
CompletionActual
Dec 1, 2022
Last update
Apr 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05462171
Responsible party
Mikolaj Przydacz (Associate Professor, MD PhD DSc PGDip FEBU, Jagiellonian University) — Principal investigator
First posted
Jul 18, 2022
Start date
Jul 1, 2022
Primary completion
Nov 1, 2022
Completion
Dec 1, 2022
Last update
Apr 18, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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