Erectile Dysfunction and the Mind: Evaluating the Influence of Depression and Illness Beliefs on Treatment Progression
Conditions: Erectile Dysfunction, Depression, Perception and Beliefs
Sponsor: Haseki Training and Research Hospital

Study Protocol 
Official Title: Erectile Dysfunction and the Mind: Evaluating the Influence of 
Depression and Illness Beliefs on Treatment Progression   
NCT Number: NCT06996925   
Document Date: August 6, 2025   
Institution: Haseki Training and Research Hospital   
Principal Investigator: Nazım Furkan Günay   
Email: nfurkangunay@gmail.com   
1. Background and Rationale 
Erectile dysfunction (ED) is a complex and multifactorial condition... 
2. Objectives 
Primary Objective: To assess the association between illness perception and depressive 
symptoms in ED patients. 
Secondary Objectives: To evaluate changes in erectile function and depression over 1 
month. 
3. Study Design 
Study Type: Observational 
Model: Cohort 
Time Perspective: Prospective 
Number of Cohorts: 1 
Target Follow-Up Duration: 1 month 

Enrollment: 120 participants anticipated 
Biospecimen Retention: None Retained 
4. Study Population 
Inclusion Criteria: 
- Male, aged 18 or older 
- Diagnosed with ED 
- Consent to participate 
Exclusion Criteria: 
- Severe psychiatric disorder 
- Hormonal or cancer therapy 
- Neurological diseases 
5. Procedures 
Patients will complete IIEF-5, B-IPQ, and PHQ-9 at baseline and at 1-month follow-up. 
 
6. Statistical Considerations: 
Descriptive statistics will be used to summarize baseline characteristics. Paired t-tests or 
Wilcoxon signed-rank tests will be used to compare baseline and follow-up scores. A p-
value < 0.05 will be considered statistically significant. 
7. Ethical Considerations 
This study was approved by the Ethics Committee of Haseki Training and Research 
Hospital on March 19, 2025 (Approval No: 23-2025). No amendments were made to the 
original protocol before submission. The current version has been approved by the ethics 
committee. 
8. Data Management 
CRFs and SOPs will guide data entry, quality checks, and confidentiality procedures.