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

Technology
Bladder health/function
Online since 4 September 2025, updated 98 days ago

About this trial

This trial is enrolling 74 individuals with spinal cord injury to test the effect of ultrasound-guided urethral balloon dilation on bladder function. Ultrasound-guided urethral balloon dilation is a procedure that uses real-time imaging and a small balloon to gently stretch the urethral muscles and potentially improve urination. If included, participants will be randomly assigned to receive either urethral balloon dilation combined with conventional rehabilitation, or conventional rehabilitation alone for 1–2 weeks. Final testing of bladder function will be performed after 3 weeks.

Included participants

Gender
All
Age
18 - 80 years
Injury level
C1 - S5
  • Severity (AIS)?
  • Time since injury
    All
    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    Have urinary retention with post-void residual volume more than 300ml
    Have urodynamic evidence of maximal urethral pressure >50cmH2O
    NOT use an indwelling urinary catherter for bladder management

    What’s involved

    Type

    Technology

    Details

    - Participants will be randomly assigned to receive either ultrasound-guided urethral balloon dilation combined with conventional rehabilitation or conventional rehabilitation alone for 1–2 weeks. - Ultrasound-guided urethral balloon dilation is a procedure that uses real-time imaging and a small balloon to gently stretch the urethral muscles and support urination. - In both groups participants will maintain a detailed micturition diary and undergo daily ultrasound measurements of residual urine volume before and after the intervention. - Final testing of bladder function will be performed after 3 weeks.

    Potential benefits

    Main benefits

    Bladder health/function

    Additional benefits

    General health

    Mental health and psychosocial factors

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more


    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 28 Apr 2025
    • Organisation
    • Qilu Hospital of Shandong University
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 28 Apr 2025
    • Organisation
    • Qilu Hospital of Shandong University

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more