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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。

CO Laser and radiofrequency compared to a sham control group in treatment of stress urinary incontinence (LARF study arm 3). A randomized controlled trial.

机构信息

Department of Gynecology, Federal University of São Paulo, Alameda Jaú 759, SP, 01420-001, São Paulo, Brazil.

出版信息

Int Urogynecol J. 2022 Dec;33(12):3535-3542. doi: 10.1007/s00192-022-05091-y. Epub 2022 Mar 7.

DOI:10.1007/s00192-022-05091-y
PMID:35254473
Abstract

INTRODUCTION AND HYPOTHESIS

Female stress urinary incontinence (SUI) is a prevalent condition, and conservative treatment options are needed. Were evaluated CO laser and radiofrequency as treatment for SUI.

METHODS

One hundred thirty-nine women with SUI were eligible and randomized in a three-arm double-blind randomized controlled trial into radiofrequency (RF), laser (LS) and sham control (SCT) groups, with 3-monthly outpatient treatment sessions. One hundred fourteen women were included, 38 in each group, during a 12-month follow-up. The primary outcomes were: subjective improvement of SUI, evaluated on a Likert scale, and objective cure, which was a composite outcome defined according to negative stress tests, voiding diary and pad test. Questionnaires were also applied. The sample size was calculated to provide 80% power to identify a 20% difference between groups, p < 0.05.

RESULTS

Subjective improvement and objective cure of SUI were identified respectively in 72.6% and 45.2% in LS and in 61.7% and 44.7% in RF, both significantly higher than the 30.0% and 14.0% in SCT. Considering only mild cases (pad test < 10 g), objective cure was achieved in 66.7% in LS, 63.6% in RF and 22.2% in SCT. Significant reduction in the number of episodes of urinary incontinence was found according to voiding diaries (p = 0.029) and pad weight (p = 0.021). A significant reduction in urgency and urinary loss during sexual intercourse was observed only with LS and RF. Improvement in quality of life was also verified by the I-QoL and ICIQ-SF in favor of the energy-treated groups.

CONCLUSIONS

CO laser and radiofrequency are outpatient options for SUI treatment, with no major complications. They had similar results and presented better results than in the sham control group.

摘要

介绍和假设

女性压力性尿失禁(SUI)是一种普遍存在的疾病,需要保守治疗。我们评估了 CO 激光和射频治疗 SUI。

方法

139 名患有 SUI 的女性符合条件并随机分为射频(RF)、激光(LS)和假对照(SCT)三组,进行为期 3 个月的门诊治疗。在 12 个月的随访中,共有 114 名女性(每组 38 名)纳入研究。主要结局是:根据 Likert 量表评估的 SUI 主观改善和客观治愈率,客观治愈率是根据阴性压力测试、排尿日记和垫试验的综合结果定义的。还应用了调查问卷。样本量计算提供了 80%的效能来识别组间 20%的差异,p<0.05。

结果

LS 组中 SUI 的主观改善和客观治愈率分别为 72.6%和 45.2%,RF 组中分别为 61.7%和 44.7%,均显著高于 SCT 组的 30.0%和 14.0%。仅考虑轻度病例(垫试验<10g),LS 组客观治愈率为 66.7%,RF 组为 63.6%,SCT 组为 22.2%。根据排尿日记(p=0.029)和垫重(p=0.021),尿失禁发作次数显著减少。仅 LS 和 RF 观察到急迫性和性交时尿失禁的显著减少。I-QoL 和 ICIQ-SF 也证实了生活质量的改善,有利于能量治疗组。

结论

CO 激光和射频是治疗 SUI 的门诊选择,无严重并发症。它们的结果相似,且优于假对照治疗组。

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