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

Air Force Military Medical University of People's Liberation Army

Status: Not yet enrolling

Conditions: Erectile Dysfunction, CTCAE

Study type: Observational

Funder types: Other

Identifiers

NCT06798350

XJLL-KY-20252014

Details and patient eligibility

About

• 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.

Enrollment: 150 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.