Improving Urination After Spinal Cord Injury with Balloon Dilation
Effect of Urethral Balloon Dilatation on Urinary Retention After Spinal Cord Injury
This study is testing if using a special balloon to help open the urethra can improve urination for people with spinal cord injuries who have trouble emptying their bladders.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06978205 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with confirmed spinal cord injuries and urinary retention.
Not a fit: Patients who do not have a history of autonomous urination prior to their spinal cord injury may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve urinary function and quality of life for patients with urinary retention after spinal cord injuries.
How similar studies have performed: While similar approaches have been explored, this specific method of ultrasound-guided urethral balloon dilation is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jinan, Shandong
- Hui Wei — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Hui Wei
- Email: 83926275@qq.com
- Phone: 18560083563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.