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绝经期女性压力性尿失禁的微消融射频治疗、盆底肌训练或两种技术联合治疗:随机对照试验6个月随访

Stress Urinary Incontinence Treatment With Microablative Radiofrequency, Pelvic Floor Muscle Training or Combination of Both Techniques in Climacteric Women: Randomized Controlled Trial 6-Month Follow-Up.

作者信息

Lunardi Anna Lygia B, Juliato Cassia R T, Slongo Helena, Machado Helymar C, Riccetto Cassio L Z

机构信息

Department of Surgery, Faculty of Medical Sciences, University of Campinas, Campinas, Brazil.

Department of Obstetrics and Gynecology, Faculty of Medical Sciences, University of Campinas, Campinas, Brazil.

出版信息

Neurourol Urodyn. 2025 Sep;44(7):1412-1424. doi: 10.1002/nau.70096. Epub 2025 Jul 2.

Abstract

INTRODUCTION

Fractional microablative radiofrequency (FMRF) has been used as an alternative to conservative treatments such as pelvic floor muscle training (PFMT). However, evidence supporting its effectiveness compared to or alongside these treatments is lacking.

OBJECTIVE

To compare the effects of FMRF, PFMT, and their combination (PFMT + FMRF) on urinary symptoms and pelvic floor function in climacteric incontinent women over a 6-month follow-up.

METHODS

This randomized, prospective, and controlled clinical trial, blinded to the investigator, included women aged 45-65 years with stress urinary incontinence, divided into three treatment groups: PFMT (12 weekly sessions), FMRF (3 monthly applications), and PFMT + RF. Urinary symptoms were assessed using the International Consultation on Incontinence Questionnaire Urinary Incontinence-Short Form (ICIQ UI-SF) and a 1-h pad test. Pelvic floor function was evaluated using PERFECT and perineometry, along with treatment satisfaction. ANOVA was used to compare the results.

RESULTS

The study included 117 women (39 in each group), with similar clinical and sociodemographic characteristics. SUI assessed by the ICIQ-SF UI showed significant improvement in all groups posttreatment, maintained at follow-up (p < 0.001), with greater variation in the PFMT + RF group (p = 0.002). The 1-h pad test also improved in all groups, with effects lasting 6 months. Muscle function assessment showed similar Power improvement across all groups (p < 0.001). Endurance improved posttreatment in the PFMT group, with a slight decline at 6 months (p = 0.027), while the FMRF + PFMT group maintained their improvement (p < 0.001). Repetition improved in the PFMT and RF + PFMT groups (p < 0.001; p = 0.001). Fast contractions increased in all groups, with significant group x time interaction (p = 0.002). Only the PFMT group showed improvement in Perineometry. At 6 months, 22.61% were very satisfied, 46.42% were satisfied, 10.71% reported being cured, and 69.04% reported symptom improvement.

CONCLUSION

The combination of techniques (RF + PFMT) showed superior results for treating UI in climacteric women over 6 months, promoting improvement in urinary symptoms and pelvic floor function compared to isolated treatments.

TRIAL REGISTRATION

The trial is registered as REBEC (Registro Brasileiro de Ensaios Clínicos; Brazilian Registry of Clinical Trials) under number RBR-9v3q33.

摘要

引言

分次微消融射频(FMRF)已被用作盆底肌肉训练(PFMT)等保守治疗的替代方法。然而,缺乏支持其与这些治疗相比或与之联合使用时有效性的证据。

目的

比较FMRF、PFMT及其联合治疗(PFMT + FMRF)对更年期尿失禁女性6个月随访期间的泌尿症状和盆底功能的影响。

方法

这项随机、前瞻性、对照临床试验对研究者设盲,纳入年龄在45 - 65岁的压力性尿失禁女性,分为三个治疗组:PFMT(每周12次治疗)、FMRF(每月3次治疗)和PFMT + RF。使用国际尿失禁咨询委员会尿失禁问卷简表(ICIQ UI - SF)和1小时垫试验评估泌尿症状。使用PERFECT和会阴测量法评估盆底功能以及治疗满意度。采用方差分析比较结果。

结果

该研究纳入了117名女性(每组39名),她们具有相似的临床和社会人口学特征。通过ICIQ - SF UI评估的压力性尿失禁在所有组治疗后均有显著改善,并在随访时保持(p < 0.001),PFMT + RF组的变化更大(p = 0.002)。所有组的1小时垫试验也有所改善,效果持续6个月。肌肉功能评估显示所有组的力量均有相似改善(p < 0.001)。PFMT组治疗后耐力有所改善,6个月时略有下降(p = 0.027),而FMRF + PFMT组保持改善(p < 0.001)。PFMT组和RF + PFMT组的重复能力有所改善(p < 0.001;p = 0.001)。所有组的快速收缩均增加,组×时间交互作用显著(p = 0.002)。只有PFMT组的会阴测量法显示有改善。6个月时,22.61%的患者非常满意,46.42%的患者满意,10.71%的患者报告治愈,69.04%的患者报告症状改善。

结论

技术联合(RF + PFMT)在治疗更年期女性尿失禁方面在6个月内显示出优于单一治疗的效果,与单独治疗相比,能促进泌尿症状和盆底功能的改善。

试验注册

该试验在巴西临床试验注册中心(REBEC;Registro Brasileiro de Ensaios Clínicos)注册,注册号为RBR - 9v3q33。

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