Trial Tests the Safety and Efficacy of Device to Treat Vulvovaginal Atrophy

Trial Tests the Safety and Efficacy of Device to Treat Vulvovaginal Atrophy

Vulvovaginal atrophy (VVA), also known as genitourinary syndrome of menopause, encompasses anatomical and functional changes in vaginal tissue affecting 60-80% of postmenopausal women. It involves symptoms such as vaginal dryness, irritation, and painful intercourse, negatively impacting sexual well-being and quality of life. Traditional treatments for VVA include topical agents and hormone therapy.

Despite its prevalence, VVA often goes unreported and untreated. However, a new study aimed to assess the efficacy and safety of a device that uses multipolar radiofrequency (RF) and pulsed electromagnetic field (PEMF) for VVA symptoms. RF and laser devices may offer alternative nonsurgical options for managing irritating VVA symptoms, but more research is needed on the topic. Therefore, the authors of this study explored the potential of combining RF and PEMF into one device for improving VVA symptoms and sexual function.

Seventy-six women with symptoms of vulvovaginal atrophy (VVA) were enrolled in this prospective, randomized, sham-controlled study. They received either active treatment with a RF + PEMF device or a sham treatment. The device used internal and external applicators with preset temperature sensors and electrode pairs to deliver RF and PEMF to the vaginal canal. Both groups received a total of 3 internal and external treatments with their respective devices every 4 weeks for a year. All participants had follow-up visits where assessments were taken at 1 month, 4 months, 6 months, and 12 months after the last treatment. 

The study assessed Vaginal Health Index (VHI), Female Sexual Function Index (FSFI), sexual satisfaction, vaginal laxity score, treatment-associated pain, and adverse events at follow-up visits over 12 months. Statistical analyses compared changes in VHI, vaginal pH, FSFI, vaginal laxity, and sexual satisfaction between the active treatment and sham groups. Adverse events and pain/discomfort were also monitored and reported.

In the end, the study results showed significant improvements in VHI scores and pH levels in the active treatment group compared to the sham group, with sustained benefits over several months. While both groups experienced enhanced sexual function, subjective assessments indicated better sexual satisfaction and vaginal laxity improvement in the active treatment group.

Satisfaction was also higher for the individuals receiving active treatment, and pain levels were minimal in both groups. No serious adverse effects were reported, though some issues like urinary incontinence and vaginal redness/inflammation occurred in the active group, but were managed effectively.

The results of this study emphasize the importance of prompt treatment for VVA to enhance women’s sexual health and quality of life. While various treatment options exist, minimally invasive energy-based methods like radiofrequency show promising results. This study demonstrated significant objective and subjective improvements in VVA symptoms with RF treatment, but individual responses may vary, and further research is needed to identify the best way to utilize this type of device in people with VVA.


  • Nappi, R. E., Martella, S., Tiranini, L., Cucinella, L., & Palacios, S. (2024). Efficacy and safety of a device that combines multipolar radiofrequency with pulsed electromagnetic field for the treatment of vulvovaginal atrophy: A randomized, sham-controlled trial. The Journal of Sexual Medicine, 21(3), 203–210.

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