clinical study on the role of inflammatory markers in patients with erectile dysfunction

Conditions: Erectile Dysfunction, CTCAE

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.


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.