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

Condition(s) studied

Investigational drug(s) / intervention(s)

Urethral Balloon Dilation: Urethral balloon dilation + conventional rehabilitation therapy. 1.A 14-Fr urethral catheter will be prefilled with sterile saline to check for balloon integrity. If intact, the saline will be completely withdrawn. 2.Ultrasound imaging will be used to precisely locate the external urethral sphincter. 3.The catheter will be fully lubricated and gently inserted into the urethra. 4.Under real-time ultrasound guidance, 2-4 mL of sterile saline will be gradually injected into the balloon to expand the external urethral sphincter. 5.Patients will be instructed to attempt urination during the procedure, and changes in voiding patterns will be observed. This procedure will be performed three times per participant. The expansion volume will increase by 0.5-1 mL per session, depending on urethral outlet resistance (urodynamic results) and degree of urethral narrowing (ultrasound assessment）Each session lasts 5 minutes. Strict aseptic techniques will be followed.

intermittent catheterization: Intermittent catheterization is based on the results of urodynamic examination to develop a personalized drinking plan and the number of catheterization, and the number of catheterization is selected according to the amount of residual urine.

Acupuncture treatment: Acupuncture treatment improves the patient's urinary function by acupuncture on the lower abdomen and lumbosacral acupoints.

Pelvic floor function training: The pelvic floor therapist assesses the patient's pelvic floor muscle condition and guides the patient to perform effective pelvic floor muscle contractions and relaxations.

Study 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

Primary outcome measure(s)

• Residual urine volume — Before treatment and three consecutive days after treatment
  Use a bladder capacity measuring instrument (model HD5, produced by Liaoning Hande Technology Co., Ltd.) to perform ultrasound testing on patients after urination and record residual urine volume.
• Voiding Diary — Before treatment and three consecutive days after treatment
  Under the supervision of researchers and medical staff, patients were instructed to keep a urinary diary during hospitalization (including catheterization time, spontaneous displacement, catheterization volume, and catheterization frequency)

Trial sites (1)

More Qilu Hospital of Shandong University trials in China

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