Status:
RECRUITING
Effect of Urethral Balloon Dilatation on Urinary Retention After Spinal Cord Injury
Lead Sponsor:
Qilu Hospital of Shandong University
Conditions:
Spinal Cord Injuries (SCI)
Urinary Bladder, Neurogenic
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Trial Objectives: This clinical trial aims to explore whether ultrasound - guided urethral balloon dilation can effectively improve the micturition function of patients with urinary retention after sp...
Detailed Description
Standard Rehabilitation Treatment (Control Group)：Participants in the control group will receive conventional rehabilitation therapy: Pelvic floor muscle training and Biofeedback electrical stimulatio...
Eligibility Criteria
Inclusion
- Age between 18-80 years old
- 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
- The spinal shock period has passed, and consciousness is clear with stable vital signs
- 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
- Urodynamic examination shows maximum urethral pressure greater than 50cmH2O
- No tumors or benign prostatic hyperplasia were found
- Patients who have had their indwelling urinary catheter removed
- Voluntary participation in research and signing of informed consent form
Exclusion
- Patients with severe heart, brain, lung and other important organ diseases or mental and cognitive disorders
- Individuals with disrupted water electrolyte and acid-base balance
- There are serious kidney diseases, bladder fistula surgery, anterior urethral sphincterotomy and other diseases
- There is a urinary system infection
Key Trial Info
Start Date :
April 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT06978205
Start Date
April 28 2025
End Date
May 1 2026
Last Update
May 18 2025
Active Locations (1)
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1
Hui Wei
Jinan, Shandong, China, 250012