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

NCT ID: NCT06798350

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2025-05-10

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Males with regular sexual activity; 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; Complete medical records; Completion of the International Index of Erectile Function-5 (IIEF-5), with IIEF-5 score ≥ 22.

Exclusion Criteria

• Patients with spinal cord injury, neurological diseases, severe heart disease, or a history of penile fibrosis; Patients undergoing treatment with phosphodiesterase type 5 inhibitors (PDE-5i); Patients diagnosed with hormonal abnormalities, hyperthyroidism, hypothyroidism, Peyronie's disease, prostatitis, urethritis, or urinary tract infections; Patients with poor rapid eye movement (REM) sleep quality.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Weijun Qin

Role: CONTACT

qinwj@fmmu.edu.cn

（+86）15521178680

Other Identifiers

XJLL-KY-20252014

Identifier Type: -

Identifier Source: org_study_id