Depression, Illness Perception, and Erectile Dysfunction Outcomes

NCT06996925 | Enrolling By Invitation

• 1 other identifier: 19.03.2025/23-2025
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the impact of illness perception and depressive symptoms on treatment outcomes in adult male patients diagnosed with erectile dysfunction (ED). The main questions it aims to answer are: Is there a relationship between negative illness perception and increased severity of depressive symptoms in ED patients? Does the change in illness perception over time correlate with changes in erectile function and depression levels? Participants will: Complete the IIEF-5 (International Index of Erectile Function - 5) to assess erectile dysfunction severity, Complete the B-IPQ (Brief Illness Perception Questionnaire) to evaluate their cognitive and emotional representations of ED, Complete the PHQ-9 (Patient Health Questionnaire - 9) to measure depressive symptoms, Repeat these assessments at baseline and at a 1-month follow-up. This study does not involve any intervention or comparison group. It is designed to track psychological and clinical changes over time and explore modifiable psychological predictors in the management of ED.

Conditions

Erectile Dysfunction; Depression; Perception and Beliefs

Keywords

erectile dysfunction; Depression; self perception

Outcome Measures

Primary Outcomes (1)

• Association between illness perception and depressive symptoms

  Change in depressive symptom scores (Patient Health Questionnaire-9, PHQ-9; range 0-27; higher scores indicate worse depressive symptoms) in relation to illness perception scores (Brief Illness Perception Questionnaire, B-IPQ; range 0-80; higher scores indicate more negative illness perceptions) at baseline and 1-month follow-up.

  Baseline and 1-month follow-up

Study Arms (1)

Erectile Dysfunction

This study includes adult male participants aged 18 and older who have been clinically diagnosed with erectile dysfunction (ED). All participants will have the condition of interest (ED), and there is no control group without the condition. The study group is homogeneous in that it consists solely of patients with ED, allowing for the evaluation of intra-individual changes over time in illness perception, depressive symptoms, and erectile functio

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the outpatient urology clinics of Haseki Training and Research Hospital and collaborating centers. All participants will be adult male patients who present with complaints consistent with erectile dysfunction and meet the diagnostic criteria during clinical evaluation.

You may qualify if:

• Male patients aged 18 years or older
• Diagnosed with erectile dysfunction by a physician
• Able and willing to provide written informed consent

You may not qualify if:

• History of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder)
• Ongoing or prior hormonal therapy or active cancer treatment
• Neurological conditions that could impact erectile function

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Education and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Erectile Dysfunction; Depression

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Furkan Gunay, Medical doctor

  Haseki Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology specialist

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: March 31, 2025
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available starting 6 months after publication of the study results and will remain available for up to 2 years.
• Access Criteria: Qualified researchers affiliated with academic institutions, research organizations, or healthcare institutions may request access to the data. What information they can access: * Individual participant data (IPD) * Study protocol * Statistical analysis plan * Informed consent form (upon request) How they can access it: Researchers must submit a formal request to the principal investigator including a brief research proposal and institutional ethical approval. If the request is approved, a data use agreement (DUA) must be signed to ensure appropriate data handling and confidentiality. Access will then be granted through a secure, password-protected electronic transfer system managed by the study team.

Locations

TU (1)