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 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT06978205
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18-80 years old
2. There is a confirmed diagnosis report of CT or MRI imaging, with the first diagnosis being spinal cord injury (complete or incomplete), which conforms to the International Classification of Spinal Cord Injury Neurology published by the American Spinal Injury Association (ASIA) in 2013
3. The spinal shock period has passed, and consciousness is clear with stable vital signs
4. In line with the diagnostic criteria of urinary retention and in combination with clinical practice: the patient can urinate autonomously before spinal cord injury, which is confirmed as spinal cord injury by clinical examination. It is manifested as retention of urine after spinal cord injury, swelling of lower abdomen, filling of bladder, dullness on percussion, residual urine volume of bladder B ultrasonic examination is more than 300ml, which shows that urination is laborious
5. Urodynamic examination shows maximum urethral pressure greater than 50cmH2O
6. No tumors or benign prostatic hyperplasia were found
7. Patients who have had their indwelling urinary catheter removed
8. Voluntary participation in research and signing of informed consent form
Exclusion Criteria:
1. Patients with severe heart, brain, lung and other important organ diseases or mental and cognitive disorders
2. Individuals with disrupted water electrolyte and acid-base balance
3. There are serious kidney diseases, bladder fistula surgery, anterior urethral sphincterotomy and other diseases
4. There is a urinary system infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06978205
Study Brief:
Protocol Section:
NCT06978205