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

Abstract

Objectives: 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.

Keywords: incontinence; magnetic stimulation; overactive bladder; randomized; urgency.