NCT06798350

Clinical Study on the Role of Inflammatory Markers in Patients With Erectile Dysfunction

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

* Project Title\*\*: Clinical Study on the Role of Inflammatory Markers in Patients with Erectile Dysfunction * Research Objective\*\*: To explore the changes in the levels of inflammatory markers in patients with erectile dysfunction (ED), providing scientific evidence for the diagnosis and treatment of ED. \*\*Study Design\*\*: Retrospective controlled study * Total Sample Size\*\*: 150 cases * Case Selection\*\*: * Inclusion Criteria for Case Group\*\*: 1. Males with regular sexual activity; 2. Age between 18 and 55 years; 3. Complete medical records; 4. Completion of the International Index of Erectile Function-5 (IIEF-5), with IIEF-5 score \< 22. Cases with an IIEF-5 score \< 22 are diagnosed with ED, while the rest are diagnosed as non-ED. * Inclusion Criteria for Control Group\*\*: 1. Males with regular sexual activity; 2. Age between 18 and 55 years; matched with the case group by age difference \< 3 years. If multiple volunteers meet the criteria, the one closest in age to the case group is selected; 3. Complete medical records; 4. Completion of the International Index of Erectile Function-5 (IIEF-5), with IIEF-5 score ≥ 22. * Exclusion Criteria\*\*: 1. Patients with spinal cord injury, neurological diseases, severe heart disease, or a history of penile fibrosis; 2. Patients undergoing treatment with phosphodiesterase type 5 inhibitors (PDE-5i); 3. Patients diagnosed with hormonal abnormalities, hyperthyroidism, hypothyroidism, Peyronie's disease, prostatitis, urethritis, or urinary tract infections; 4. Patients with poor rapid eye movement (REM) sleep quality. * Efficacy Assessment\*\*: * Observational Indicators\*\*: Peripheral blood count, including monocyte count, neutrophil count, lymphocyte count, and biochemical markers such as C-reactive protein. \*\*Safety Evaluation Indicators\*\*: Reproductive system damage. \*\*Statistical Methods\*\*: Data analysis will be performed using R software (version 4.1.6). All statistical tests will be two-sided, with P values \< 0.05 considered significant. Normality of data will be assessed using the Shapiro-Wilk test. Data with normal distribution will be presented as mean ± standard deviation, and data with non-normal distribution will be presented as median \[interquartile range\]. Baseline characteristics will be compared using independent sample t-tests, Mann-Whitney U tests, or chi-square/Fisher's exact tests. Multivariate analysis will be conducted using logistic regression to estimate odds ratios (OR) and 95% confidence intervals (CI). Missing data will be handled using appropriate methods based on the data missing mechanism. To control Type I errors, Bonferroni correction will be applied during multiple comparisons. All analysis procedures and code will be documented in detail to ensure the reproducibility of the analysis.

Conditions

• Erectile Dysfunction, CTCAE

Timeline

• Start date: 2025-03-10
• Primary completion: 2025-04-10
• Completion: 2025-05-10
• First posted: 2025-01-29
• Last updated: 2025-01-29