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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.

DOI:10.1007/s00192-025-06076-3
PMID:39945802
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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本文引用的文献

1
European Board and College of Obstetrics and Gynaecology (EBCOG) position statement on the use of laser vaginal devices for treatment of genitourinary syndrome of menopause, vaginal laxity, pelvic organ prolapse and stress urinary incontinence.欧洲妇产科委员会(EBCOG)关于使用激光阴道设备治疗更年期泌尿生殖综合征、阴道松弛、盆腔器官脱垂和压力性尿失禁的立场声明。
Eur J Obstet Gynecol Reprod Biol. 2024 Aug;299:342-344. doi: 10.1016/j.ejogrb.2024.05.021. Epub 2024 May 21.
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Laser and Pelvic Floor Muscle Training for Urinary Incontinence: A Randomized Clinical Trial.激光与盆底肌训练治疗尿失禁:一项随机临床试验
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CO laser therapy for management of stress urinary incontinence in women: a systematic review and meta-analysis.
CO激光疗法治疗女性压力性尿失禁:一项系统评价与荟萃分析
Ther Adv Urol. 2023 Nov 10;15:17562872231210216. doi: 10.1177/17562872231210216. eCollection 2023 Jan-Dec.
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A randomized trial comparing vaginal laser therapy and pelvic floor physical therapy for treating women with stress urinary incontinence.一项比较阴道激光治疗与盆底物理治疗治疗压力性尿失禁女性的随机试验。
Neurourol Urodyn. 2023 Sep;42(7):1445-1454. doi: 10.1002/nau.25244. Epub 2023 Jul 14.
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Long-term Safety of Synthetic Midurethral Sling Implantation for the Treatment of Stress Urinary Incontinence in Adult Women: A Systematic Review.合成尿道中段吊带植入术治疗成年女性压力性尿失禁的长期安全性:一项系统评价
Eur Urol Open Sci. 2023 Jun 10;54:10-19. doi: 10.1016/j.euros.2023.05.013. eCollection 2023 Aug.
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Up-to-Date Procedures in Female Stress Urinary Incontinence Surgery: A Concise Review on Bulking Agents Procedures.女性压力性尿失禁手术中的最新方法:填充剂手术的简明综述。
Medicina (Kaunas). 2022 Jun 8;58(6):775. doi: 10.3390/medicina58060775.
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CO Laser and radiofrequency compared to a sham control group in treatment of stress urinary incontinence (LARF study arm 3). A randomized controlled trial.CO 激光与射频治疗与假对照组比较治疗压力性尿失禁(LARF 研究组 3)。一项随机对照试验。
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Int Urogynecol J. 2021 Mar;32(3):609-614. doi: 10.1007/s00192-020-04393-3. Epub 2020 Jun 20.