Randomized trial: treatment of genitourinary syndrome of menopause using radiofrequency

Abstract

Objective

A randomized controlled study was conducted to evaluate the safety and efficacy of radiofrequency treatment in postmenopausal women not willing to use or presenting a contraindication for menopause hormone therapy (MHT) and suffering from genitourinary syndrome of menopause (GSM).

Methods

A prospective randomized open study evaluated the effect of radiofrequency treatment versus a gel (control group) in postmenopausal women suffering from GSM. Patients were assessed at baseline and after 10–12 weeks of treatment for severity of vulvovaginal atrophy, dyspareunia, pH, vaginal smear maturation index, Vaginal Health Index and Female Sexual Function Index. The difference at baseline and after 10–12 weeks of treatment and the difference in improvement were tested between groups by a two-sample t-test and the Mann–Whitney test.

Results

Due to the COVID-19 pandemic, we were only able to treat 48 patients (24 patients using radiofrequency and 24 patients using a gel). Globally, at the end of the study, there were no differences in changes of the measured outcomes between the group of women treated with radiofrequency and the control group.

Conclusion

Radiofrequency treatment was found to be safe, but was not superior to a gel, although the study lacked power. The study was registered at ClinicalTrials.gov (NCT03857893).

摘要

目的: 进行一项随机对照研究, 以评估射频治疗对不愿意应用或有绝经激素治疗(MHT)禁忌证和患有绝经生殖泌尿综合征(GSM)的绝经后女性的安全性和有效性。

方法: 一项前瞻性随机开放研究评估了射频治疗与凝胶治疗(对照组)对患有GSM的绝经后女性的效果。在基线和治疗10-12周后评估患者外阴阴道萎缩的严重程度、性交困难、pH值、阴道涂片成熟指数、阴道健康指数和女性性功能指数。基线和治疗10-12周后的差异以及改善的差异通过双样本t检验和Mann-Whitney检验在组间进行检验。

结果: 由于新冠肺炎疫情, 我们只能治疗48名患者(24名患者采用射频, 24名患者应用凝胶)。从全球来看, 在研究结束时, 接受射频治疗的患者组和对照组之间的测量结果变化没有差异。

结论: 射频治疗被发现是安全的, 但并不优于凝胶, 尽管这项研究缺乏说服力。该研究在ClinicalTrials.gov注册(NCT03857893)。

Keywords:

• Menopause
• genitourinary syndrome of menopause
• vulvovaginal atrophy
• randomized trial
• low-energy radiofrequency

Acknowledgements

The novel low-energy dynamic quadripolar radiofrequency (DQRF) system was borrowed during the study period from Novavision Group S.P.A., Milan, Italy.

Disclosure statement

No potential conflict of interest was reported by the authors.

Potential conflict of interest

None of the authors has a conflict of interest for this study. S.R. discloses receiving grants from Bayer (for research) and from Viatris, Theramex and Abbott (speakers bureau).

Additional information

Funding

The study was supported by IRIS Grant; Vesalius Association Grant; conseil medical du CHU St Pierre (all non-profit–non-commercial grants).