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

Recruiting now · Not applicable

Conditions studied: Spinal Cord Injuries (SCI), Urinary Bladder, Neurogenic, Urinary Retention

In brief

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.

Key facts

Study ID: NCT06978205
Run by: Qilu Hospital of Shandong University
People needed: 74
Starts: 2025-04-28
Expected to finish: 2026-05-01
Last updated by the study team: 2025-05-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Hui Wei — Jinan, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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