Effects of repetitive functional magnetic stimulation in the sacral nerve in patients with neurogenic detrusor overactivity after suprasacral spinal cord injury: a study protocol for a randomized controlled trial

Trials, 2023 · DOI: https://doi.org/10.1186/s13063-023-07207-1 · Published: March 16, 2023

Simple Explanation

This study aims to evaluate the effectiveness of repetitive functional magnetic stimulation (rFMS) on the sacral nerve for patients suffering from neurogenic detrusor overactivity (NDO) following a spinal cord injury above the sacrum. Participants will be randomly assigned to either receive real rFMS treatment or a sham stimulation. Both groups will also receive standard treatments like medication, urine management, acupuncture, and health education. The study will assess bladder function, symptoms, and quality of life before, during, and after the treatment period to determine if rFMS can significantly improve these aspects for patients with NDO after suprasacral SCI.

Study Duration

8 weeks intervention, 8 weeks follow-up

Participants

66 patients with NDO after suprasacral SCI

Evidence Level

Level 1, Randomized Controlled Trial

Key Findings

1
The primary outcome will be bladder compliance measured by urodynamic testing, which assesses the relationship between bladder capacity and detrusor pressure.
2
Secondary outcomes include the residual volume of the bladder, Spinal Cord Injury-Quality of Life (SCI-QOL), bladder diary, Neurogenic Bladder Symptom Score (NBSS), and pudendal nerve electromyography.
3
The study hypothesizes that rFMS of the sacral nerve will significantly improve bladder function, reduce symptoms, and enhance the quality of life for patients with NDO after suprasacral SCI.

Research Summary

This study protocol outlines a randomized, double-blind, sham-controlled trial to assess the efficacy of repetitive functional magnetic stimulation (rFMS) of the sacral nerve in treating neurogenic detrusor overactivity (NDO) following suprasacral spinal cord injury (SCI). The trial involves 66 participants randomly assigned to either a real rFMS group or a sham stimulation group, with both groups receiving concomitant treatments such as medication, acupuncture, and health education. Assessments will occur at baseline, during the 8-week treatment period, and at 8 weeks post-treatment. The primary outcome is bladder compliance, measured via urodynamic testing, with secondary outcomes including residual bladder volume, SCI-QOL, bladder diary, NBSS, and pudendal nerve electromyography, aiming to provide a comprehensive evaluation of rFMS efficacy and safety.

Practical Implications

Clinical Practice

If proven effective, rFMS could provide a non-invasive treatment option for NDO after suprasacral SCI, potentially reducing reliance on medication or invasive procedures.

Future Research

The study findings can inform future research on neuro-modulation techniques for neurogenic bladder, including exploring the underlying mechanisms and optimizing treatment protocols.

Patient Quality of Life

Successful rFMS treatment could significantly improve the quality of life for individuals with NDO after SCI, by improving bladder function, reducing incontinence, and enhancing overall well-being.

Study Limitations

1
The study only includes patients with suprasacral SCI, limiting the generalizability of the findings to those with subsacral SCI.
2
The follow-up period is limited to 8 weeks, which may not capture the long-term effects of rFMS on NDO.
3
As a single-center trial, the results might be influenced by the specific patient population and clinical practices of the Affiliated Hospital of Southwest Medical University.

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