非侵入式盆底电刺激治疗仪的有效性与安全性研究

目的 通过与侵入式盆底电刺激治疗仪进行对比，研究非侵入式盆底电刺激治疗仪的有效性与安全性。方法 在COMSOL多物理场仿真软件中构建盆底部位的三维仿真模型，改变刺激电压的频率和幅值，进行多组电流密度分布仿真，结合离体组织实验进行有效性与安全性评价。结果和结论 非侵入式盆底电刺激能够通过增加刺激脉冲电压的幅值和频率达到与侵入式盆底电刺激治疗仪相近的盆底肌刺激效果，增加电极数量对刺激效果也具有提升作用。在电极刺激部位垫湿巾或涂导电膏能避免电烧伤并提升刺激效果。创新之处 关于非侵入式盆底电刺激治疗的有效性与安全性目前缺乏研究论证，该研究表明非侵入式盆底电刺激具有潜在的临床应用前景，可以为后续的临床研究提供参考。

Study on the Effectiveness and Safety of Non-invasive Pelvic Floor Electrical Stimulation Therapy Instruments

Objective To study the effectiveness and safety of non-invasive pelvic floor electrical stimulation therapy instruments comparing with invasive ones. Methods The 3D simulation model of the pelvic floor was constructed in COMSOL Multiphysics simulation software, and the frequency and amplitude of the stimulation voltage were changed to simulate the distribution of multiple groups of current density, and the effectiveness and safety were evaluated in combination with in vitro tissue experiments. Results and Conclusion Non-invasive pelvic floor electrical stimulation can achieve the pelvic floor muscle stimulation effect similar to that of invasive pelvic floor electrical stimulation therapy instruments by increasing the amplitude and frequency of the stimulation voltage. Placing wet wipes or applying conductive ointment at the stimulation site can avoid electric burns and improve the stimulation effect. Innovation The effectiveness and safety of non-invasive pelvic floor electrical stimulation therapy instruments are currently lacking research evidence. This study indicates that non-invasive pelvic floor electrical stimulation has potential clinical application prospects and can provide reference for subsequent clinical research.