Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Cidade Universitária, Barão Geraldo, Campinas, SP 13083-881, Brazil.
J Sex Med. 2024 Aug 1;21(8):700-708. doi: 10.1093/jsxmed/qdae068.
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.
STRENGTHS & LIMITATIONS: 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.
阴道松弛（VL）是一种阴道过度松弛的抱怨，其患病率在不同研究中为 24%至 38%不等。
本研究旨在比较射频（RF）和盆底肌肉训练（PFMT）对治疗阴道松弛女性的效果。
本前瞻性、平行、非劣效性、随机临床试验于 2020 年 2 月至 2021 年 12 月在一家三级医院进行，招募年龄≥18 岁且抱怨 VL 的女性。在研究开始时和干预后 30 天和 6 个月对两组（RF 和 PFMT）进行评估。每组 42 名参与者足以证明在 90%的功效下，使用单侧 1 型错误率为 0.025 和非劣效性边界为 4 的女性性功能指数（FSFI）总分上的性功能差异。分析基于意向治疗和方案。
167 名招募的参与者中，87 名被纳入（RF：n=42；PFMT：n=45）。所有问卷在两组和随访期间均提高了（P<.05）其总分和子量表评分。治疗 30 天后，RF 在改善 FSFI 总分方面不劣于 PFMT（意向治疗分析中的平均差值-0.08[95%置信区间，-2.58 至 2.42]；方案分析中的平均差值-0.46[95%置信区间，-2.92 至 1.99]）；然而，这一结果在 6 个月的治疗后并未得到维持。两组的盆底肌肉收缩均显著改善（RF：P=.006，30 天；P=.049，6 个月；PFMT：P<.001，30 天和 6 个月），PFMT 组的效果更好。
RF 和 PFMT 治疗 30 天和 6 个月后，性、阴道和尿症状均得到改善；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种经过验证的问卷来评估生活质量、性功能和尿症状，此外还评估了盆底肌肉收缩，并对盆腔器官脱垂的定量进行了分类，旨在两个随访期内评估解剖学变化。局限性在于缺乏假对照（第三臂），并且由于 COVID-19 大流行，研究人员难以对治疗进行盲法评估。
