PURPOSE: We designed an investigational study and placebo controlled trial to evaluate the efficacy of magnetic stimulation of the sacral roots for treating urinary frequency and urge incontinence. MATERIALS AND METHODS: A total of 48 women 43 to 75 years old (mean age 61) with the complaint of urinary frequency and/or urge incontinence were studied. We applied 15 Hz. repetitive magnetic stimulation of the sacral roots with 50% intensity output for 5 seconds per minute for 30 minutes. Urodynamic investigations during magnetic stimulation were performed in 11 cases to evaluate acute effects for lowering urinary tract function. Another 37 women were enrolled in a placebo controlled study to investigate short-term effects. The mean number of voids daily, mean urine volume per void, number of leaks for 3 days and quality of life score were evaluated before and 1 week after stimulation. RESULTS: Urodynamic investigations revealed apparent elevation in mean maximum urethral closure pressure plus or minus standard deviation during stimulation in all 11 cases (8.4 +/- 3.6 cm. water, p = 0.00001) and a significant increase in mean bladder capacity after stimulation (58.2 +/- 50.2 ml, p = 0.003). In the placebo controlled study all parameters significantly improved in the active stimulation group. Intergroup comparison showed that mean urine volume per void, mean number of leaks and mean quality of life score improved more significantly in the active than in the sham stimulation group (23.5 +/- 25.6 ml. versus 6.2 +/- 22.5, p = 0.04, 3.6 +/- 4.1 versus 0.4 +/- 1.4, p = 0.04 and 1.4 +/- 1.3 versus 0.4 +/- 0.8, p = 0.01, respectively). No adverse effects were noted in any patients. CONCLUSIONS: These results suggest that magnetic stimulation of the sacral roots may be useful for treating urinary frequency and urge incontinence.

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