Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
Study NCT ID:
NCT06798350
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-29
First Post:
2025-01-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study on the Role of Inflammatory Markers in Patients With Erectile Dysfunction
Sponsor:
Xijing Hospital
Organization:
Study Overview
Official Title:
Clinical Study on the Role of Inflammatory Markers in Patients With Erectile Dysfunction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: