Magnetic stimulation of the pelvic floor found not effective in the control of urinary incontinence. A study was conducted to determine the safety and effectiveness of non-invasive static magnetic stimulation (SMS) of the pelvic floor compared to placebo in the treatment of women aged 60 years and over with urinary incontinence in Australia.
A double blind randomised controlled trial was undertaken with 122 women, aged 60 years and over who had had urinary incontinence for at least 6 months. Subjects were randomly assigned to the active SMS group or the placebo group. Each participant in the treatment group wore an undergarment incorporating 15 static magnets of 800 to 1200 Gauss anterior, posterior and inferior to the pelvis for at least 12 hours a day for three months. The placebo group wore the same undergarment with inert metal disks replacing the magnets. Outcome measures included the 24 hour pad test, the Bristol Female Lower Urinary Tract Symptoms ? Scored Form (BFLUTS-SF) questionnaire, the Incontinence Severity Index (ISI) and a 24 hour Bladder Diary.
Sixty-two women were randomised to the intervention group and 60 to the control group. Fifty-one participants in the intervention group and 50 participants in the control group provided at least some follow-up data. There were no statistically significant differences in change in objective outcome measures (Pad test, frequency of continent and incontinent episodes, BFLUTS-SF, ISI, Bothersomeness Score) between the two groups by the end of the study. There was initial evidence of subjective improvement in symptoms of urinary incontinence for those wearing the pads when compared to a placebo controlled group. However, once those who could correctly identify their group allocation were removed from the analysis there were no statistically significant differences apparent between the groups. The qualitative data suggested that the garment was uncomfortable and hot to wear.
No significant differences between the magnetic and nonmagnetic undergarments on the key outcome measures were found. This could be due to a variety of reasons: no magnetic effect on these outcomes, small sample size, issues related to design and protocol adherence. The qualitative data suggested that there are some design issues with the product especially for use in a sub-tropical climate. This meant that the recruitment to a clinical trial was difficult and adherence to the protocol was even more difficult. For these reasons the lack of effect seen in the intervention group must be treated with caution. It may be that there is an effect if the garment is worn as designed; however, the effectiveness of the garment cannot be confirmed from the results of this study. Further research needs to be undertaken into the basic physics of the strength and flux of the magnetic field generated by the product. Once this work is completed additional animal and clinical trials may be planned. Further clinical trials would require from 250 to 2500 participants in both intervention and control groups depending on the primary end-point used in the study.