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.