Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-01-02 @ 8:03 AM
Study NCT ID:
NCT06798350
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-29
First Post:
2025-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study on the Role of Inflammatory Markers in Patients With Erectile Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-05-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2025-01-23', 'studyFirstSubmitQcDate': '2025-01-23', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The diagnosis of ED', 'timeFrame': 'A retrospective study observing patients approximately 1 month before and after diagnosis.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erectile Dysfunction, CTCAE']}, 'descriptionModule': {'briefSummary': "* Project Title\\*\\*: Clinical Study on the Role of Inflammatory Markers in Patients with Erectile Dysfunction\n* Research Objective\\*\\*:\n\nTo 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.\n\n\\*\\*Study Design\\*\\*: Retrospective controlled study\n\n* Total Sample Size\\*\\*:\n\n 150 cases\n* Case Selection\\*\\*:\n* Inclusion Criteria for Case Group\\*\\*:\n\n 1. Males with regular sexual activity;\n 2. Age between 18 and 55 years;\n 3. Complete medical records;\n 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.\n* Inclusion Criteria for Control Group\\*\\*:\n\n 1. Males with regular sexual activity;\n 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;\n 3. Complete medical records;\n 4. Completion of the International Index of Erectile Function-5 (IIEF-5), with IIEF-5 score ≥ 22.\n* Exclusion Criteria\\*\\*:\n\n 1. Patients with spinal cord injury, neurological diseases, severe heart disease, or a history of penile fibrosis;\n 2. Patients undergoing treatment with phosphodiesterase type 5 inhibitors (PDE-5i);\n 3. Patients diagnosed with hormonal abnormalities, hyperthyroidism, hypothyroidism, Peyronie's disease, prostatitis, urethritis, or urinary tract infections;\n 4. Patients with poor rapid eye movement (REM) sleep quality.\n* Efficacy Assessment\\*\\*:\n* Observational Indicators\\*\\*:\n\nPeripheral blood count, including monocyte count, neutrophil count, lymphocyte count, and biochemical markers such as C-reactive protein.\n\n\\*\\*Safety Evaluation Indicators\\*\\*: Reproductive system damage.\n\n\\*\\*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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Inclusion Criteria for Case Group:\n\nMales 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.\n\nInclusion Criteria for Control Group:\n\nMales 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.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- 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.\n\nExclusion Criteria:\n\n\\- 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."}, 'identificationModule': {'nctId': 'NCT06798350', 'briefTitle': 'Clinical Study on the Role of Inflammatory Markers in Patients With Erectile Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Clinical Study on the Role of Inflammatory Markers in Patients With Erectile Dysfunction', 'orgStudyIdInfo': {'id': 'XJLL-KY-20252014'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Weijun Qin', 'role': 'CONTACT', 'email': 'qinwj@fmmu.edu.cn', 'phone': '（+86）15521178680'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}