New concept for treating female stress urinary incontinence with radiofrequency

ABSTRACT Purpose: To evaluate the clinical response and adverse effects of radiofrequency on the urethral meatus in the treatment of stress urinary incontinence in women. Materials and Methods: This phase one study included ten women with Stress Urinary Incontinence (SUI). The evaluation consisted of 1 hour Pad tests to quantify urine loss and to assess the degree of procedure satisfaction by using the Likert scale. To evaluate safety, we observed the number of referred side effects. Results: Average age was 53.10 years±7.08 years. In assessing the final Pad Test, 70% showed a reduction and 30% a worsening of urinary loss. Using the Pad Test one month later, there was a reduction in all patients (p=0.028). The degree of satisfaction was 90% and no side effects have been observed. One patient reported burning sensation. Conclusion: The treatment of SUI with radiofrequency on the urethral meatus has no adverse effects, being a low risk method that reduces urinary loss in women. However, to increase the validity of the study, larger clinical trials are warranted.

摘要
目的：评估尿道外口射频（radiofrequency）治疗女性压力性尿失禁（Stress Urinary Incontinence, SUI）的临床疗效与不良反应。
材料与方法：本Ⅰ期临床试验纳入10名压力性尿失禁女性患者。评估内容包括1小时垫尿试验以量化尿液漏失量，并采用李克特（Likert）量表评估受试者对治疗操作的满意程度。安全性评价环节中，我们统计了报告的不良反应发生例数。
结果：受试者平均年龄为53.10±7.08岁。末次垫尿试验结果显示，70%的患者尿液漏失量有所减少，30%的患者漏失量加重。术后1个月复查垫尿试验，所有患者的漏失量均出现降低（p=0.028）。患者治疗满意度达90%，未观察到明显不良反应，仅1名患者报告存在烧灼感。
结论：采用尿道外口射频治疗女性压力性尿失禁安全性良好，属于低风险治疗手段，可改善女性尿液漏失症状。但为提升本研究的论证效度，后续仍需开展更大样本量的临床试验。