NCT05679999

Brief Summary

The aim of the present study was to examine the relationship between degrees of erectile dysfunction and carotid artery intima media thickness (CIMT) and its effect on the medical treatment of this disease. Considering that there are vascular pathologies in the etiology, it is important to reveal vascular disorders with CIMT, which is a non-invasive, easily applicable method, and to use it in the grading and treatment of erectile dysfunction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
181

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

December 26, 2022

Last Update Submit

January 11, 2023

Conditions

Erectile Dysfunction Due to Arterial Disease

Outcome Measures

Primary Outcomes (1)

  • Coexistence of erectile dysfunction and increased CIMT

    Association erectile dysfunction with CIMT measurement

    2 years

Study Arms (2)

Control group

31 male volunteers who did not have erectile dysfunction

Diagnostic Test: CIMT (Carotid artery intima media thickness measurement)

Patient group

150 patients with erectile dysfunction

Diagnostic Test: CIMT (Carotid artery intima media thickness measurement)

Interventions

CIMT (Carotid artery intima media thickness measurement)DIAGNOSTIC_TEST

Carotid artery intima media thickness measurement with ultrasound

Control groupPatient group

Eligibility Criteria

Age40 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsErectile dysfunction is a condition that only affects men.
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over 40 years of age and under 70 years old with erectile dysfunction

You may qualify if:

  • \. Patients over 40 years of age and under 70 years

You may not qualify if:

  • Patients under 40 years of age and over 70 years old
  • Patients whose consent can not be obtained
  • Those with endocrine disease except type II diabetes mellitus
  • Concomitant malignancy
  • \. Psychiatric problems 7. Previous penile or pelvic surgery/trauma 8. Penile curvature / Peyronie's disease 9. Patients receiving treatment for erectile dysfunction 10. Chronic liver failure 11. Chronic kidney failure 12. Neurological disease 13. Patients with low testosteron level (≤300 ng/dL)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Urology Department

Study Record Dates

First Submitted

December 26, 2022

First Posted

January 11, 2023

Study Start

January 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations

TU(1)