Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
NCT ID:
NCT06798350
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.
Study:
NCT06798350
Study Brief:
Protocol Section:
NCT06798350