Magnetic stimulation of the sacral roots for the treatment of stress incontinence: An investigational study and placebo controlled trial

Purpose: We designed an investigational study and placebo controlled trial to evaluate the potential efficacy of magnetic stimulation of the sacral ro ots for the treatment of stress incontinence. Materials and Methods: A total of 75 patients with stress incontinence were studied. A 15 Hz. repetitive magnetic stimulation of the sacral roots with 50% intensity output and duration of 5 seconds per minute was applied for 30 minutes. Urodynamic investigations under magnetic stimulation were perfo rmed in 13 patients to evaluate acute effects to lower urinary tract functi on. There were 62 women (mean age 58 years) enrolled in a placebo controlle d study to investigate the short-term efficacy of magnetic stimulation. The number of leaks for 3 days, amount of urine loss on a pad test and quality of life score were evaluated before and 1 week after stimulation. Results: The urodynamic investigations revealed an apparent elevation of ur ethral closure pressure induced by stimulation (mean 8.2 +/- 3.0 cm H2O, p = 0.0000004) and a significant increase in bladder capacity after stimulati on (mean 40.0 +/- 51.0 ml., p = 0,0152). In the placebo controlled study th e number of leaks and amount of urine loss on a pad test significantly decr eased more in the active than in the sham stimulation group (p = 0.0023 and 0.0377, respectively). The quality of life score significantly improved in the active stimulation group (p = 0.0006) in contrast to no significant im provement in the sham stimulation group. The improvement rate in the active stimulation group was 74%, which was significantly higher than the 32% in the sham stimulation group (p = 0.0009). No adverse effects were noted in a ny patients. Conclusions: These results suggest that magnetic stimulation of the sacral roots may be useful for the treatment of stress incontinence. Further studi es are needed to evaluate the long-term efficacy of this potential treatmen t.