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Search / Trial NCT06978205

Effect of Urethral Balloon Dilatation on Urinary Retention After Spinal Cord Injury

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · May 10, 2025

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

Spinal Cord Injuries Neurogenic Bladder Urinary Retention Urethral Balloon Dilation Zelen Design Randomized Controlled Clinical Trial

ClinConnect Summary

This clinical trial is studying a new treatment method called ultrasound-guided urethral balloon dilation to see if it can help improve urination in patients who have urinary retention after a spinal cord injury. Urinary retention means that a person has difficulty emptying their bladder, which can lead to uncomfortable symptoms and affect their quality of life. The trial will compare two groups: one group will receive the new treatment along with standard rehabilitation therapies, while the other group will only receive standard therapies.

To be eligible for this trial, participants should be between 18 and 80 years old, have a confirmed spinal cord injury, and have experienced urinary retention after their injury. They must also be able to urinate on their own before their injury and have certain medical conditions ruled out. Participants will keep a daily diary to track their urination patterns and will have their bladder's urine volume checked before and after the treatment. This trial is currently looking for volunteers, and it's a great opportunity for those who want to explore new ways to manage their urinary issues after a spinal cord injury.

Gender

ALL

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

About Qilu Hospital Of Shandong University

Qilu Hospital of Shandong University is a leading medical institution dedicated to advancing healthcare through innovative clinical research and patient-centered care. Affiliated with Shandong University, the hospital integrates clinical practice with education and research, fostering an environment that promotes scientific discovery and the development of new therapies. With a commitment to high standards of clinical excellence and ethical research practices, Qilu Hospital plays a pivotal role in enhancing patient outcomes and contributing to the global medical community through a diverse range of clinical trials and studies.

Locations

Jinan, Shandong, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported