Abstract

Background: Stress urinary incontinence (SUI) is a prevalent health condition that substantially impairs quality of life. Extracorporeal electromagnetic stimulation (EES) has emerged as a non-invasive therapeutic option for pelvic floor rehabilitation, though supporting evidence regarding its efficacy remains limited. This study aimed to assess the safety and effectiveness of high-intensity focused electromagnetic technology (HIFEM) in women with SUI. Materials and Methods: A prospective single-arm study was conducted at a Portuguese hospital, enrolling eleven women, diagnosed with SUI. Participants underwent six sessions of HIFEM treatment using an electromagnetic chair. Outcomes were evaluated at baseline, post-treatment, and at three-month follow-up using the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and King’s Health Questionnaire (KHQ). Results: Baseline ICIQ-SF scores (11.70 ± 3.09) decreased post-treatment to 9.30 (± 2.79), reflecting a subjective improvement. However, scores rose again at three months to 10.40 ± 2.21. Similarly, KHQ scores showed an immediate reduction, followed by a return to near-baseline levels by the three-month follow-up. No statistically significant differences were observed at any time point (ICIQ-SF baseline vs. post-treatment: Z = -1.82, p = 0.07), a finding attributed to the limited statistical power. Nevertheless, the mean ICIQSF improvement was within the Minimum Clinically Important Difference (MCID) range. The intervention was well-tolerated, with no reported adverse events or withdrawals due to discomfort. Conclusions: HIFEM therapy was found to be a safe and well-tolerated approach in this pilot cohort. While no statistical significance was achieved, the observed short-term clinical improvement was patient-meaningful. These findings, however, highlighted the transient nature of the treatment’s effect. Definitive conclusions regarding sustained efficacy cannot be drawn based on this single-arm pilot study

Keywords

stress urinary incontinence, pelvic floor, electromagnetic stimulation, quality of life, HIFEM