激光和盆底肌肉训练治疗尿失禁:随机临床试验

Samantha Conde Rocha-Rangel, Gláucia Miranda Varella Pereira, C. Juliato, L. G. O. Brito
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摘要

重要意义盆底肌肉训练(PFMT)被认为是保守治疗女性压力性尿失禁(SUI)的首选方法。本研究的目的是评估 PFMT 和点阵式 CO2 激光疗法是否能改善 SUI 女性患者的症状。研究设计包括一项平行、随机、非盲、非劣效试验,144 名 18 岁或以上 SUI 女性患者中的 94 人被随机分为两组。CO2 激光组(47 人)每月接受 3 次阴道激光治疗。PFMT 组(47 人)每周接受 2 次治疗。主要结果是3个月和6个月后两组尿失禁国际咨询问卷-尿失禁简表(ICIQ-UI-SF)总分的平均差异。主要次要结果是盆底症状评估问卷(盆底影响问卷-简表 7 [PFIQ-7])、性功能(女性性功能指数 [FSFI])以及治疗后的改善情况(患者总体改善印象 [PGI-I])。在两个随访期和分析中,CO2 激光与盆底肌肉运动疗法相比均未达到非劣效区。盆底肌肉训练改善了基线至 3-6 个月期间的 FSFI 欲望域,而 CO2 激光则改善了 3 个月后的 FSFI 性高潮、疼痛和总分,以及 6 个月后的 FSFI 性高潮和总分。结论在治疗 3-6 个月后,点阵 CO2 激光疗法的效果不逊于 PFMT。两组患者的 ICIQ-UI-SF 评分均有所下降,患有 SUI 的女性可考虑采用这两种方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Laser and Pelvic Floor Muscle Training for Urinary Incontinence: A Randomized Clinical Trial.
IMPORTANCE Pelvic floor muscle training (PFMT) is considered the first option as a conservative treatment for female stress urinary incontinence (SUI). However, there is still debate whether energy-based devices are effective for treating SUI. OBJECTIVE The objective of this study was to assess whether PFMT and fractional CO2 laser therapy may improve symptoms in women with SUI. STUDY DESIGN A parallel, randomized, nonblinded, noninferiority trial included 94 of 144 women 18 years or older with SUI randomized into 2 groups. The CO2 laser group (n = 47) received 3 vaginal applications at monthly intervals. The PFMT group (n = 47) underwent 2 weekly sessions. Primary outcome was the mean difference of International Consultation on Incontinence Questionnaire-Urinary Incontinence Short-Form (ICIQ-UI-SF) total scores between groups after 3 and 6 months. Main secondary outcomes were questionnaires for assessment of pelvic floor symptoms (Pelvic Floor Impact Questionnaire-Short Form 7 [PFIQ-7]), sexual function (Female Sexual Function Index [FSFI]), and improvement after treatment (Patient Global Impression of Improvement [PGI-I]). RESULTS A reduction in the ICIQ-UI-SF total score, PFIQ total score, and the Urinary Impact Questionnaire score was perceived between baseline and 3-6 months in both groups. CO2 laser did not reach the noninferiority margin when compared with PFMT in both follow-up periods and analyses. Pelvic floor muscle training has improved the FSFI desire domain between baseline and 3-6 months, whereas CO2 laser improved the FSFI orgasm, pain, and total score after 3 months and FSFI orgasm and total score after 6 months. PGI-I assessment has shown an improvement in both groups. CONCLUSION Fractional CO2 laser therapy was noninferior to PFMT after 3-6 months of treatment. Both groups presented a reduction in the ICIQ-UI-SF scores, and both methods could be considered for women with SUI.
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