RecruitingNot Applicable

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

China74 participantsStarted 2025-04-28

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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 criteria

What they're measuring

Residual urine volume

Timeframe: Before treatment and three consecutive days after treatment

Voiding Diary

Timeframe: Before treatment and three consecutive days after treatment

Trial details

NCT IDNCT06978205

SponsorQilu Hospital of Shandong University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-27

Contact for this trial

Hui Wei

18560083563 83926275@qq.com

View on ClinicalTrials.gov More Spinal Cord Injuries (SCI) trials