Multicenter, randomized, sham-controlled study on the efficacy of magnetic stimulation for women with urgency urinary incontinence.

OBJECTIVE

To evaluate the efficacy and safety of magnetic stimulation for the treatment of urinary incontinence in women with overactive bladder.

METHODS

A total of 151 women with urgency incontinence were randomized to the active stimulation group or the sham stimulation group in a 2:1 order. An armchair type magnetic stimulator was used for 25-min magnetic stimulation twice a week, with the maximum magnetic flux density of 560 mT peak at 10 Hz. The sham device was set to deliver in a 5-s "on"-5-s "off" pulsing manner with the maximum intensity of 20.4% of active stimulation at 1 Hz. The study consisted of a baseline period for 1 week, and a treatment period for 6 weeks. The primary end-point was the number of leaks/week from the bladder diary. The secondary end-points were the number of voids and urgency/24 h, mean and maximum voided volume, and the quality of life assessment.

RESULTS

Changes from baseline in the active and sham group, respectively, were -13.08 ± 11.00 and -8.68 ± 13.49 in leaks/week (P = 0.038), -2.65 ± 2.52 and -1.53 ± 2.39 in number of urgency/24 h (P = 0.011), and 14.03 ± 34.53 mL and -4.15 ± 40.60 mL in mean voided volume (P = 0.0056). As for safety, except for diarrhea and constipation, no patients experienced any device-related adverse event.

CONCLUSIONS

Magnetic stimulation is effective for the treatment of urgency incontinence in female patients with overactive bladder.