Clinical Study on the Role of Inflammatory Markers in Patients With Erectile Dysfunction
- 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**:
- Males with regular sexual activity;
- Age between 18 and 55 years;
- Complete medical records;
- 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**:
- 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.
- 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 Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Weijun Qin
- Phone Number: （+86）15521178680
- Email: qinwj@fmmu.edu.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Inclusion Criteria for Case Group:
Males with regular sexual activity; Age between 18 and 55 years; Complete medical records; 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:
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.
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The diagnosis of ED
Time Frame: A retrospective study observing patients approximately 1 month before and after diagnosis.
|
The diagnosis of ED is based on the IIEF-5 questionnaire score, with patients scoring <22 being diagnosed with ED, and the remaining patients being diagnosed as non-ED.
|
A retrospective study observing patients approximately 1 month before and after diagnosis.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XJLL-KY-20252014
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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