OBJECTIVE: To evaluate the effects of sacral magnetic stimulation (SMS) on functional and urodynamic improvement in refractory stress urinary incontinence (SUI) patients. DESIGN: A sham-controlled, double-blind parallel study design with a 4.5-month follow-up. SETTING: A tertiary hospital PARTICIPANTS: Thirty-four female SUI patients (aged 45 to 75 y) refractory to first-line management were allocated to an experimental group (n = 20) or a sham (n = 14) group. INTERVENTIONS: The SMS protocol consisted of 5-Hz, 20-minute treatments administered over the bilateral third sacral roots, with the intensity set at approximately 70% of the maximal output, for 12 consecutive weekdays. MAIN OUTCOME MEASURES: Urodynamic assessments and 2 life stress questionnaires, namely the Urge-Urinary Distress Inventory (Urge-UDI) and Overactive Bladder Questionnaire (OAB-q), were administered pre- and post-SMS intervention. We administered the Urge-UDI (primary outcome measure) and OAB-q at 3-week intervals during the follow-up period until 18 weeks after the final intervention. RESULTS: Following the SMS intervention, the experimental group exhibited significant improvements in both Urge-UDI and OAB-q scores postintervention (p = 0.011 to 0.014), and at the follow-up visits (p < 0.001 to 0.007) compared with the sham group. In addition, significant increases in bladder capacity, urethral functional length (UFL), and the pressure transmission ratio (p = 0.009 to 0.033) were noted postintervention. Multivariate regression analysis revealed that patients with more severe symptoms benefited more from SMS. A poorer baseline Urge-UDI score and a shorter UFL were associated with a greater response to SMS. CONCLUSIONS: Our observations of a greater response to SMS in patients with more severe SUI than in those with mild symptoms, as well as the long-term benefits of the treatment, confirm the efficacy of SMS in treating SUI.

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