Randomized, double‐blind, sham‐controlled evaluation of the effect of functional continuous magnetic stimulation in patients with urgency incontinence

Abstract Aims To evaluate the effect of functional continuous magnetic stimulation (FCMS) on urgency incontinence in randomized, sham‐controlled manner. Methods Thirty‐nine patients with urgency incontinence, 16 males and 23 females (aged 66.0 ± 16.5 years), who were refractory to pelvic floor muscle training (PFMT), were randomly assigned either to the treatment schedule performing 10‐week active treatment, followed by 4‐week non‐treatment interval and then by 10‐week sham treatment (A–S, n = 20) or to that performing the sham treatment first followed by 10‐week active treatment (S–A, n = 19). Results At 10 weeks, the number of leaks/week, the total score of the International Consultation on Incontinence‐Questionnaire: Short Form (ICIQ‐SF), and maximum cystometric capacity (MCC) were significantly improved as compared with the initial levels ( P < 0.001, P < 0.001, and P = 0.003, respectively) in the former group, but not in the latter group. Four (20.0%) patients were cured in the A–S group, while no patient was cured in the S–A group.At the end of the A–S schedule (24 weeks of study), the effect of the active treatment was still maintained at a significantly improved level, as compared with the initial level. At the end of the S–A schedule, the number of leaks/week was significantly improved as compared with the initial level and with its 10‐week level ( P < 0.001 and P = 0.049, respectively), as well as ICIQ‐SF total score ( P = 0.001 and P = 0.006, respectively). MCC significantly increased from its initial level ( P = 0.030). Conclusion Magnetic stimulation was effective on urgency incontinence in comparison to sham stimulation in this small patient group. Neurourol. Urodynam. 26:767–772, 2007. © 2007 Wiley‐Liss, Inc.