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Recruiting NCT06978205

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

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Trial Parameters

Condition Spinal Cord Injuries (SCI)
Sponsor Qilu Hospital of Shandong University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 74
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2025-04-28
Completion 2026-04-27
Interventions
Urethral Balloon Dilationintermittent catheterizationAcupuncture treatment

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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 spinal cord injury, and to evaluate the safety of this treatment method. The main questions it attempts to answer are: Can ultrasound - guided urethral balloon dilation reduce the residual urine volume and improve the quality of life of patients with urinary retention after spinal cord injury? Trial Design: Researchers will compare the group receiving ultrasound - guided urethral balloon dilation combined with conventional rehabilitation therapy (the experimental group) with the group receiving only conventional rehabilitation therapy (the control group) to determine the therapeutic effect of ultrasound - guided urethral balloon dilation on urinary retention after spinal cord injury. Tasks for Participants: Participants in the experimental group will receive ultrasound - guided urethral balloon dilation and cooperate with conventional rehabilitation therapy (including acupuncture therapy, pelvic floor biofeedback electrical stimulation, and pelvic floor function training). Participants in the control group will receive only conventional rehabilitation therapy for a period of 1 - 2 weeks. During the intervention, patients are required to strictly record a micturition diary under the guidance of researchers or medical staff. The diary should cover details such as daily spontaneous urine output, daily catheterized urine output, daily urine leakage volume, and daily frequency of catheterization. Residual urine volume will be detected every day for three days before the intervention and three days after the intervention.

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.

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