Comparison of High-Intensity Electromagnetic Therapy and Pelvic Floor Muscle Exercises in Women with Urinary Incontinence: A Randomized Controlled Trial.

Background: Stress urinary incontinence is common in women and can negatively affect quality of life. This study evaluated the effects of pelvic floor muscle training alone and combined with high-intensity focused electromagnetic therapy on pelvic floor muscle function, urinary symptoms, and quality of life. Methods: This randomized controlled trial included 44 women with stress urinary incontinence, randomly assigned to either the high-intensity focused electromagnetic therapy group or the pelvic floor muscle training group (22 per group). Both groups received supervised pelvic floor muscle training three times weekly for 8 weeks. In addition, the high-intensity focused electromagnetic therapy group received twice-weekly treatment for 6 weeks, with 28-minute sessions. The primary outcome measure was pelvic floor muscle activity, assessed using surface electromyography biofeedback. The secondary outcome measures were urinary symptoms and quality of life, evaluated using the Urogenital Distress Inventory-6, the International Consultation on Incontinence Questionnaire-Short Form, and the King's Health Questionnaire. Appropriate parametric and nonparametric tests were used for data analysis, and statistical significance was set at p<0.05. Results: No significant between-group differences were found at baseline (p>0.05). Both groups showed significant post-treatment improvements in pelvic floor muscle function and urinary symptoms. In the high-intensity focused electromagnetic therapy group, significant improvements were observed in electromyography parameters, UDI-6, and ICIQ-SF scores (all p<0.001). Improvements in the pelvic floor muscle training group were also significant but less pronounced. After treatment, the high-intensity focused electromagnetic therapy group showed significantly better outcomes than the pelvic floor muscle training group in electromyography parameters, UDI-6, ICIQ-SF, and King's Health Questionnaire total score (all p≤0.03). After Holm correction, the HIFEM + PFMT group showed significantly greater improvements than the PFMT group in Work Peak EMG activity, maximum voluntary contraction, and UDI-6 scores, with large effect sizes (g = 1.41, 1.26, and -1.22, respectively; adjusted p ≤ 0.035). Other outcomes did not remain significant after adjustment for multiple comparisons. Conclusion: Both pelvic floor muscle training alone and in combination with high-intensity focused electromagnetic therapy were effective in women with stress urinary incontinence. However, the combined approach provided greater improvements in several objective and subjective outcomes, suggesting that high-intensity focused electromagnetic therapy may be a useful adjunct to exercise-based conservative treatment. Trial Registration: ClinicalTrials.gov, NCT06450795. Registered June 8, 2024.