MedTrace Logo

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

NCT06798350 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-01-29

No results posted yet for this study

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.

Conditions

  • Erectile Dysfunction, CTCAE

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2025-04-10
Completion
2025-05-10

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06798350 on ClinicalTrials.gov