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经阴道CO2激光和微消融射频治疗后尿失禁持续时间有多久?一项多组随机临床试验(LARF-arm3)的四年随访

How Long Does Urinary Continence Last After Treatment with Intravaginal CO Laser and Microablative Radiofrequency? A Four-Year Follow-up of a Multi-arm Randomized Clinical Trial (LARF-arm3).

作者信息

Seki Ana Silvia, de Mello Bianchi-Ferraro Ana Maria Homem, Bonetti Tatiana Carvalho Sousa, Fonseca Eliana Suelotto Machado, Sartori Marair Gracio Ferreira, de Jarmy-Di Bella Zsuzsanna Ilona Katalin

机构信息

Department of Gynecology, Federal University of Sao Paulo (UNIFESP-EPM), Rua Conselheiro Zacarias 111, São Paulo, SP, Brazil, 01429-020.

出版信息

Int Urogynecol J. 2025 Feb 13. doi: 10.1007/s00192-025-06076-3.

Abstract

INTRODUCTION AND HYPOTHESIS

CO laser (LS) and microablative radiofrequency (RF) are outpatient options for stress urinary incontinence (SUI) treatment. The aim of this study was to evaluate the lasting effects of SUI treatment using intravaginal CO LS and microablative RF.

METHODS

This is a long-term follow-up of a prospective double-blind multi-arm randomized controlled trial, involving women with pure or predominant SUI. Participants received three monthly sessions of LS, RF, or were part of a sham control group (SCT) and were followed up, every 6 months, for 48 months to assess continence rates, defined by the composed outcome: no symptoms, negative stress test, and negative 7-day voiding diary.

RESULTS

One hundred and thirty-nine women were eligible and randomized into the three groups. One hundred and fourteen participants concluded the treatment protocol. The women's mean age was 50.4 (± 9.5) years. The results showed that both LS and RF treatments led to a mean duration of urinary continence of 26.7 months and 24.58 months respectively, compared with 8.21 months in the SCT group. No major complications were observed.

CONCLUSION

Although the continence rates declined over the time, more than 50% of women in perimenopause, with mild to moderate SUI, pure or predominant SUI, remained without complaints of SUI for at least 24 months after LS or RF application sessions, with no major complications reported.

摘要

引言与假设

CO2激光(LS)和微消融射频(RF)是压力性尿失禁(SUI)门诊治疗的选择。本研究的目的是评估使用阴道内CO2激光和微消融射频治疗SUI的长期效果。

方法

这是一项前瞻性双盲多臂随机对照试验的长期随访研究,纳入单纯性或主要为SUI的女性。参与者接受为期三个月的LS、RF治疗,或作为假手术对照组(SCT)的一部分,每6个月随访一次,共随访48个月,以评估尿失禁率,尿失禁率由综合结果定义:无症状、压力试验阴性和7天排尿日记阴性。

结果

139名女性符合条件并随机分为三组。114名参与者完成了治疗方案。女性的平均年龄为50.4(±9.5)岁。结果显示,LS和RF治疗的尿失禁平均持续时间分别为26.7个月和24.58个月,而SCT组为8.21个月。未观察到重大并发症。

结论

尽管随着时间推移尿失禁率有所下降,但超过50%的围绝经期轻度至中度SUI、单纯性或主要为SUI的女性在接受LS或RF治疗后至少24个月内无SUI主诉,且未报告重大并发症。

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