Clinical trial NCT06798350: Clinical Study on the Role of Inflammatory Markers in Patients With Erectile Dysfunction
Official title: Clinical Study on the Role of Inflammatory Markers in Patients With Erectile Dysfunction
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Erectile Dysfunction, CTCAE
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The diagnosis of ED
timeFrame: A retrospective study observing patients approximately 1 month before and after diagnosis.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: