Improving Urination After Spinal Cord Injury with Balloon Dilation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of ultrasound-guided urethral balloon dilation in enhancing urinary function for patients experiencing urinary retention following spinal cord injuries. Participants will be divided into two groups: one receiving the balloon dilation along with standard rehabilitation therapy, and the other receiving only the standard therapy. The study aims to assess whether the intervention can reduce residual urine volume and improve the quality of life for these patients. The procedure will be performed three times per participant, with careful monitoring of changes in urination patterns.

Why it matters

Who can join: the full rules

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

Where it's running

• Hui Wei
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Hui Wei
• Email: 83926275@qq.com
• Phone: 18560083563

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.