Abstract
Objective: To assess the effectiveness and safety of combining non-ablative Er:YAG laser with a magnetic stimulation device for treating stress or mixed urinary incontinence.
Methods: In a prospective, single-arm pilot trial, 24 women with stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) with predominant SUI symptoms were treated with three intravaginal Er:YAG laser sessions and six High Intensity Tesla magnetic Stimulation (HITS®) therapies. The primary objective was to improve incontinence symptoms, as measured by changes in the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and the Questionnaire for Urinary Incontinence Diagnosis (QUID) scores from the baseline. Secondary objectives included improvement in sexual function as assessed by Female Sexual Function Index (FSFI) scores, pelvic floor muscle contraction assessed by palpation, treatment durability (measured at 3 and 6 months), and patient-reported improvement and discomfort. Repeated measures ANOVA and the Friedman test (with Bonferroni correction) were used for normally and non-normally distributed variables, respectively.
Results: At baseline, one third of participants had moderate SUI and over 60% had severe SUI. After treatment with the Er:YAG laser and HITS, significant symptom improvements were observed. At 6-months, 13% were symptom-free, 44% had mild symptoms, and 35% had moderate symptoms. The mean ICIQ-UI score decreased significantly from 12.46 ± 3.40 to 5.48 ± 4.06 (p≤0.001). QUID scores indicated significant improvements in both SUI and MUI. Over 90% of the patients were satisfied with the results. Pelvic floor muscle improvement occurred in over 70% of participants, and FSFI scores showed overall sexual function improvement. The treatments were well tolerated with minimal adverse effects.
Conclusions: The combination of non-ablative Er:YAG laser and HITS effectively and safely improved SUI and MUI symptoms in adult women.
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