Electromagnetic stimulation for overactive bladder in myelomeningocele children: randomized controlled trial.
Heba A Khalifa, Walaa E Heneidy, Mostafa Abdelrazek and 5 others
Real electromagnetic stimulation over the sacral region produced greater improvement in bladder storage and continence than sham stimulation, though both groups improved.
All children also took anticholinergic medication throughout the three-month trial.
Key findings
1All four urodynamic measures (maximum cystometric capacity, expected maximum cystometric capacity, first uninhibited detrusor contraction volume, and detrusor leak point pressure) improved significantly in both groups, with the real stimulation group showing larger gains on every measure.
2Twelve of twenty children in the real stimulation group became entirely dry after three months, compared to four of twenty in the sham group.
3Both groups received Oxybutynin (0.3 mg/kg/day) throughout the trial, so the improvement seen in the sham group cannot be attributed to stimulation alone.
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What it does not show
Both groups received Oxybutynin throughout, so the sham group's improvement reflects medication plus placebo stimulation. The true added effect of the stimulation is the difference between the two groups, not the absolute improvement in either. The trial ran for three months only, with no follow-up after the device was stopped. It is unknown whether the bladder gains persist once stimulation ends. Single-blind design: the therapist delivering treatment knew which group each child was in, even though the assessor did not. Single centre, 40 children total. The sample was sized for the urodynamic measures but is small for detecting differences in the incontinence score. The mechanism of action in children with myelomeningocele is not established. The authors base their explanation on adult spinal cord injury data and state it remains hypothetical. The study did not assess voiding efficiency or sphincter activity, so it is unclear whether the voiding phase of the bladder cycle was affected.
Declared interests
The authors declare no conflict of interest and no external funding.
The easy way to misread this
Do not read the improvement as proof that electromagnetic stimulation alone works. Both groups received Oxybutynin throughout the trial, and the sham group also showed significant improvement on every bladder measure. The contribution of the medication versus the stimulation cannot be separated from this design.
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