Efficacy of Sacral Nerve Modulation on Urinary and Defecation Dysfunction After Spinal Cord Injury:A Prospective, Single-arm Study

Bladder health/function
Online since 6 November 2024, updated 400 days ago

About this trial

The aim of this study is to investigate the long-term efficacy of sacral nerve modulation surgery in the treatment of neurogenic lower urinary tract dysfunction caused by incomplete spinal cord injury...

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - S5
  • Severity (AIS)?
  • AIS-B
    AIS-C
    AIS-D
    Time since injury
    All
    Healthy volunteers
    Yes
    C1-S5

    What’s involved

    Type

    Observational

    Details

    Spinal cord injury is a serious type of central nervous system injury that not only causes movement disorders, but also damages the bladder, intestines, and autonomic nervous circuits related to sexual function, leading to urinary and defecation disorders. Sacral nerve modulation is a technology that applies low-frequency electric pulse to specific sacral nerve continuously to affect and regulate the function of target organs, so as to treat urgent urinary incontinence, overactivity of bladder, urinary retention, fecal incontinence and other diseases. However, there is currently no consensus on whether this technology can treat urinary and defecation dysfunction caused by spinal cord injury, and its specific mechanism still needs to be studied. Existing research shows that this technique can reduce the excitability of sphincter by inhibiting the protective reflex to treat urinary retention; Treating detrusor overactivity by inhibiting detrusor muscle activity without affecting urethral resistance and detrusor muscle contraction during urination. This study hypothesizes that sacral nerve modulation intervention after spinal cord injury can reduce bladder spasms, maintain bladder compliance, bladder capacity, and low bladder filling pressure, delay the progression of bladder fibrosis and hydronephrosis after spinal cord injury, and improve symptoms such as constipation. Based on the above evidence and hypotheses, we designed a single arm clinical trial to evaluate the effectiveness and safety of sacral nerve modulation surgery in treating urinary and defecation dysfunction after incomplete spinal cord injury, especially in preventing complications such as bladder fibrosis and hydronephrosis. We also evaluated the impact of sacral nerve modulation surgery on the quality of life of patients after spinal cord injury, as well as the improvement effect of sacral nerve modulation surgery on urinary and reproductive system related symptoms and intestinal symptoms.

    Potential benefits

    Main benefits

    Bladder health/function

    Additional benefits

    General health

    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
    • 1 Dec 2023
    • Organisation
    • Qilu Hospital of Shandong University
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Dec 2023
    • 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