Clinical Study on the Role of Inflammatory Markers in Patients With Erectile Dysfunction
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Erectile Dysfunction, CTCAE. Базовые параметры: от 18 лет · Мужчины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
* 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.
Первичные конечные точки
- The diagnosis of ED [Срок оценки: A retrospective study observing patients approximately 1 month before and after diagnosis.]
Критерии участия
Критерии включения
\- 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.
Критерии исключения
\- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT06798350 · XJLL-KY-20252014