Abstract

We evaluated the efficacy and safety of a device that uses electromagnetic technology to treat urinary incontinence, with an emphasis on health-related quality of life. A total of 47 female subjects from 18 to 80 years old were enrolled. After block randomization, treatment consisted of 2 pulsed planar magnetic stimulation sessions per week for 4 weeks (8 sessions). Validated questionnaires: Female Sexual Function Index, International Consultation on Incontinence Questionnaire for Urinary Incontinence: Short Form, and Pelvic Floor Bothersome. Follow-ups were performed at weeks 1, 9, and 14. The present study is one of the first clinical trials published evaluating the efficacy and safety of the electromagnetism-based device with flat configuration in patients with stress urinary incontinence, showing a reduction in PFBQ, ICQSF, and Oxford test scores during follow-up, and significantly at week 14 of follow-up, which implied a favorable impact on clinical outcomes, quality of life, and sexuality. The improved results in the treatment group compared with the simulated group show that pulsed magnetic stimulation is a safe and attractive non-invasive alternative for patients who prefer non-surgical treatments.

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