Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-25 @ 4:43 AM
NCT ID:
NCT07239518
Eligibility Criteria:
Inclusion Criteria:
1. Patients who have undergone radical prostatectomy with a confirmed pathological diagnosis of prostate cancer.
2. One week post-radical prostatectomy (RP).
3. Karnofsky Performance Score (KPS) ≥ 60 or ECOG Performance Status 0-1.
4. Age between 50 and 85 years.
5. Signed informed consent.
Exclusion Criteria:
1. Pathological results show positive surgical margins.
2. Previous treatment for post-operative urinary incontinence, such as cystostomy, urethral sphincter reconstruction, or urethral suspension.
3. Currently or within the last 6 months receiving treatment with principles similar to acupuncture (e.g., electroacupuncture, moxibustion, warm moxibustion).
4. Active urinary system infection (excluding asymptomatic lower urinary tract infection).
5. Known severe heart diseases, such as severe arrhythmia, severe heart failure, acute myocarditis, constrictive pericarditis, pericardial tamponade, severe valvular disease, or heart failure.
6. Known liver damage or potential severe liver disease (ALT or AST \> 10 times the normal limit).
7. Known severe renal impairment (eGFR \< 25mL/min/1.73m2), planned or ongoing dialysis, or acute contrast-induced nephropathy at screening.
8. Known dysfunction of other vital organs or severe primary diseases, such as hematopoietic system diseases.
9. Known coagulation dysfunction (with typical clinical diagnosis or clear laboratory test results).
10. Patients with mental illness or cognitive impairment; patients with severe depression, alcohol dependence, or a history of drug abuse.
11. Urinary incontinence known to be due to other reasons.
12. According to the investigator's judgment, the patient is not suitable for this study or has a high probability of dropout (e.g., frequent changes in work environment that make follow-up difficult).
13. Life expectancy ≤ 6 months, as judged by the investigator.
14. Currently participating in other clinical trials.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT07239518
Study Brief:
Protocol Section:
NCT07239518