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

NCT06798350 | Not Yet Recruiting

• 1 other identifier: XJLL-KY-20252014
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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\*\*:
• 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.

Conditions

Erectile Dysfunction, CTCAE

Outcome Measures

Primary Outcomes (1)

• The diagnosis of ED

  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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Xijing Hospital: lead

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Weijun Qin

CONTACT

（+86）15521178680; qinwj@fmmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: March 10, 2025
• Primary Completion: April 10, 2025
• Study Completion: May 10, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01