Abstract：
Vaginal laxity (VL) is a complaint of excessive vaginal looseness with a prevalence ranging from 24% to 38% across studies.
The study sought to compare the effect of radiofrequency (RF) and pelvic floor muscle training (PFMT) on the treatment of women with VL.
From February 2020 to December 2021, a prospective, parallel, noninferiority, randomized clinical trial was carried out in women ≥18 years of age and complaining of VL in a tertiary hospital. Two groups (RF and PFMT) were evaluated at the beginning of the study and 30 days and 6 months postintervention. A total of 42 participants per arm was sufficient to demonstrate a difference in sexual function on the Female Sexual Function Index at 90% power, 1-sided type 1 error of 0.025 with a noninferiority margin of 4 on the FSFI total score. Analysis was intention-to-treat and per-protocol based.
The primary endpoint was the change of FSFI score after treatment, and the secondary outcomes were improvement in symptoms of VL and changes in questionnaire scores of sexual distress, vaginal symptoms, and urinary incontinence, in the quantification of pelvic organ prolapse, and pelvic floor muscle (PFM) contraction.
Of 167 participants recruited, 87 were included (RF: n = 42; PFMT: n = 45). All questionnaires improved (P < .05) their total scores and subscales in both groups and during the follow-ups. After 30 days of treatment, RF was noninferior to PFMT to improving FSFI total score (mean difference -0.08 [95% confidence interval, -2.58 to 2.42]) in the per-protocol analysis (mean difference -0.46 [95% confidence interval, -2.92 to 1.99]) and in the intention-to-treat analysis; however, this result was not maintained after 6 months of treatment. PFM contraction improved significantly in both groups (RF: P = .006, 30 days; P = .049, 6 months; PFMT: P < .001, 30 days and 6 months), with better results in the PFMT group.
Sexual, vaginal, and urinary symptoms were improved after 30 days and 6 months of treatment with RF and PFMT; however, better results were observed in the PFMT group after 6 months.
The present randomized clinical trial used several validated questionnaires evaluating quality of life, sexual function and urinary symptoms, in addition to assessing PFM contraction and classifying the quantification of pelvic organ prolapse aiming at anatomical changes in two follow-up periods. The limitations were the lack of a sham-controlled group (third arm) and the difficulty of blinding researchers to assess treatments due to the COVID-19 pandemic.
After 30 days and 6 months of treatment, sexual, vaginal, and urinary symptoms improved with RF and PFMT; however, better results were observed in the PFMT group after 6 months. RF was noninferior to PFMT in improving FSFI total score after 30 days; however, this result was not maintained after 6 months of treatment.
The study sought to compare the effect of radiofrequency (RF) and pelvic floor muscle training (PFMT) on the treatment of women with VL.
From February 2020 to December 2021, a prospective, parallel, noninferiority, randomized clinical trial was carried out in women ≥18 years of age and complaining of VL in a tertiary hospital. Two groups (RF and PFMT) were evaluated at the beginning of the study and 30 days and 6 months postintervention. A total of 42 participants per arm was sufficient to demonstrate a difference in sexual function on the Female Sexual Function Index at 90% power, 1-sided type 1 error of 0.025 with a noninferiority margin of 4 on the FSFI total score. Analysis was intention-to-treat and per-protocol based.
The primary endpoint was the change of FSFI score after treatment, and the secondary outcomes were improvement in symptoms of VL and changes in questionnaire scores of sexual distress, vaginal symptoms, and urinary incontinence, in the quantification of pelvic organ prolapse, and pelvic floor muscle (PFM) contraction.
Of 167 participants recruited, 87 were included (RF: n = 42; PFMT: n = 45). All questionnaires improved (P < .05) their total scores and subscales in both groups and during the follow-ups. After 30 days of treatment, RF was noninferior to PFMT to improving FSFI total score (mean difference -0.08 [95% confidence interval, -2.58 to 2.42]) in the per-protocol analysis (mean difference -0.46 [95% confidence interval, -2.92 to 1.99]) and in the intention-to-treat analysis; however, this result was not maintained after 6 months of treatment. PFM contraction improved significantly in both groups (RF: P = .006, 30 days; P = .049, 6 months; PFMT: P < .001, 30 days and 6 months), with better results in the PFMT group.
Sexual, vaginal, and urinary symptoms were improved after 30 days and 6 months of treatment with RF and PFMT; however, better results were observed in the PFMT group after 6 months.
The present randomized clinical trial used several validated questionnaires evaluating quality of life, sexual function and urinary symptoms, in addition to assessing PFM contraction and classifying the quantification of pelvic organ prolapse aiming at anatomical changes in two follow-up periods. The limitations were the lack of a sham-controlled group (third arm) and the difficulty of blinding researchers to assess treatments due to the COVID-19 pandemic.
After 30 days and 6 months of treatment, sexual, vaginal, and urinary symptoms improved with RF and PFMT; however, better results were observed in the PFMT group after 6 months. RF was noninferior to PFMT in improving FSFI total score after 30 days; however, this result was not maintained after 6 months of treatment.
摘要：
背景：阴道松弛（VL）是阴道过度松弛的主诉，在整个研究中的患病率为24％至38％。
目的：该研究试图比较射频（RF）和盆底肌肉训练（PFMT）对VL女性的治疗效果。
方法：从2020年2月到2021年12月，平行,非自卑，在三级医院对≥18岁且主诉VL的女性进行了随机临床试验.在研究开始时以及干预后30天和6个月对两组（RF和PFMT）进行评估。每个手臂共有42名参与者足以证明女性性功能指数在90％功率下的性功能差异，1侧1型误差为0.025，FSFI总分的非劣效性为4。分析是基于意向治疗和方案的。
结果：主要终点是治疗后FSFI评分的变化，次要结果是VL症状的改善和性困扰问卷评分的变化，阴道症状,和尿失禁，在盆腔器官脱垂的量化中，和盆底肌肉（PFM）收缩。
结果：在招募的167名参与者中，纳入87例(RF:n=42;PFMT:n=45)。在两组和随访期间，所有问卷的总分和分量表都得到了改善（P<0.05）。治疗30天后，RF在提高FSFI总分方面不劣于PFMT(平均差-0.08[95%置信区间，-2.58至2.42]）在每个方案分析中（平均差-0.46[95%置信区间，-2.92至1.99])，并且在意向治疗分析中；然而，该结果在治疗6个月后未得到维持.两组PFM收缩均有显著改善(RF:P=.006,30天;P=.049,6个月;PFMT:P<.001,30天和6个月),PFMT组结果较好。
结论：性，阴道,使用RF和PFMT治疗30天和6个月后，尿液症状得到改善；然而，PFMT组在6个月后观察到更好的结果.
■本随机临床试验使用了几个经过验证的问卷来评估生活质量，性功能和泌尿症状，除了评估PFM收缩和对盆腔器官脱垂的定量分类外，还针对两个随访期的解剖变化进行了分类。局限性是缺乏假对照组（第三组），以及由于COVID-19大流行而使研究人员难以评估治疗方法。
结论：治疗30天和6个月后，性,阴道,RF和PFMT改善了泌尿系统症状；然而，PFMT组在6个月后观察到更好的结果.30天后，RF在改善FSFI总分方面不劣于PFMT；然而，该结果在治疗6个月后未得到维持.
目的：该研究试图比较射频（RF）和盆底肌肉训练（PFMT）对VL女性的治疗效果。
方法：从2020年2月到2021年12月，平行,非自卑，在三级医院对≥18岁且主诉VL的女性进行了随机临床试验.在研究开始时以及干预后30天和6个月对两组（RF和PFMT）进行评估。每个手臂共有42名参与者足以证明女性性功能指数在90％功率下的性功能差异，1侧1型误差为0.025，FSFI总分的非劣效性为4。分析是基于意向治疗和方案的。
结果：主要终点是治疗后FSFI评分的变化，次要结果是VL症状的改善和性困扰问卷评分的变化，阴道症状,和尿失禁，在盆腔器官脱垂的量化中，和盆底肌肉（PFM）收缩。
结果：在招募的167名参与者中，纳入87例(RF:n=42;PFMT:n=45)。在两组和随访期间，所有问卷的总分和分量表都得到了改善（P<0.05）。治疗30天后，RF在提高FSFI总分方面不劣于PFMT(平均差-0.08[95%置信区间，-2.58至2.42]）在每个方案分析中（平均差-0.46[95%置信区间，-2.92至1.99])，并且在意向治疗分析中；然而，该结果在治疗6个月后未得到维持.两组PFM收缩均有显著改善(RF:P=.006,30天;P=.049,6个月;PFMT:P<.001,30天和6个月),PFMT组结果较好。
结论：性，阴道,使用RF和PFMT治疗30天和6个月后，尿液症状得到改善；然而，PFMT组在6个月后观察到更好的结果.
■本随机临床试验使用了几个经过验证的问卷来评估生活质量，性功能和泌尿症状，除了评估PFM收缩和对盆腔器官脱垂的定量分类外，还针对两个随访期的解剖变化进行了分类。局限性是缺乏假对照组（第三组），以及由于COVID-19大流行而使研究人员难以评估治疗方法。
结论：治疗30天和6个月后，性,阴道,RF和PFMT改善了泌尿系统症状；然而，PFMT组在6个月后观察到更好的结果.30天后，RF在改善FSFI总分方面不劣于PFMT；然而，该结果在治疗6个月后未得到维持.
