Abstract
INTRODUCTION AND HYPOTHESIS: This study aimed to compare the efficacy of magnetic stimulation (MStim) and transcutaneous tibial nerve stimulation (TTNS), both combined with bladder training (BT), in women with idiopathic overactive bladder (iOAB). METHODS: Women with iOAB were randomized into three groups: group 1 received BT only; group 2 received MStim plus BT; and group 3 received TTNS plus BT. MStim and TTNS were administered twice weekly, 30 min per session, for a total of 12 sessions over 6 weeks. The primary outcome was the positive response rate, defined as ≥ 50% fewer incontinence episodes, measured via a 3-day bladder diary at 6 weeks. Seconder outcomes included incontinence severity (pad test), voiding frequency, incontinence episodes, nocturia, number of pads used, symptom severity (OAB-V8), QoL (IIQ-7). RESULTS: According to the sample size calculation, 66 women were included in the study, with 22 assigned to each group. The three groups were comparable in terms of demographic and clinical characteristics. The positive response rate (primary outcome) was significantly higher in groups 2 and 3 compared to group 1 at week 6 (66.7% and 90.5% vs. 35.0%, p = 0.001), with no significant difference between groups 2 and 3 (p = 0.130). Both stimulation groups (each n = 21) demonstrated significant improvements in incontinence severity, incontinence episodes, number of pads used, symptom severity, QoL, and treatment satisfaction compared to the BT-only group (n = 20) (p < 0.0167). No significant differences were found between group 2 and group 3 for these parameters. Voiding frequency significantly improved in group 3 (med 11 to 6) compared to group 1 (med 11 to 8) and group 2 (med 12 to 8) (p < 0.0167). CONCLUSIONS: Both MStim plus BT and TTNS plus BT are more effective than BT alone in women with iOAB. These two stimulation methods have similar clinical efficacy, with TTNS demonstrating greater effectiveness in reducing voiding frequency. CLINICAL TRIAL REGISTRATION: This study was registered with ClinicalTrials.gov number, NCT05387824.