Clinical Trial

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

Recruiting
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Record status
This record was last updated May 18, 2025 (before its estimated April 27, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT06978205
Lead Sponsor Qilu Hospital of Shandong University
Conditions Spinal Cord Injuries (SCI), Urinary Bladder, Neurogenic, Urinary Retention
Enrollment 74 participants
Start Date 2025-04-28
Primary Completion 2026-04-27 (estimated)
Study Completion 2026-05-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-18