NCT04607798

Multi-polar RF and PEMF for Treatment of Vulvovaginal Atrophy

Clinical Evaluation of the Safety and Efficacy of Using Multi-Polar RF and PEMF Technologies for the Treatment of Symptoms Associated With Vulvovaginal Atrophy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Venus Concept · Industry
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The study evaluates the use of multi-polar radiofrequency (RF) and pulsed electro-magnetic fields (PEMF) energies for the treatment of symptoms related to genitourinary syndrome of menopause (GSM)/vulvovaginal atrophy (VVA). All subjects will receive a total of three internal treatments at four week intervals. Subjects will be followed up at one and four months after treatment is complete.

Detailed description

Largely observed in the post-menopausal population, a significant subset of pre-menopausal and peri-menopausal women are also affected by symptoms associated with GSM, the etiology being similar in that there is an interruption in normal estrogen production resulting in a hypoestrogenic state. Symptoms related to GSM include vaginal dryness, decreased lubrication, decreased vaginal elasticity, irritation and discomfort of the vaginal and vulvar tissues in general that can affect sexual health. Traditional treatments, such as hormone replacement therapy (HRT), are often the treatment of choice however come with potential risks and many women are not suitable candidates, or have contraindications to its use. Development of new technologies to address these concerns is warranted. RF energy-based treatment for symptoms of GSM has been used with success to promote elasticity restoration and improve moisture of the vaginal mucosa, and is well established in literature for the treatment of facial and neck laxity, stress urinary incontinence and skin tightening of tissue. Several studies show favorable results with improvement of vaginal laxity and sexual function with RF treatment. The addition of pulsed electromagnetic field (PEMF) energy to multi-polar RF therapy has also been shown to enhance the results of the RF therapy. RF therapy has already been reported to be successful in treatment of symptoms related to elasticity restoration and improve moisture of the vaginal mucosa. This study will investigate whether adding PEMF to RF therapy is safe and efficacious for the treatment of symptoms related to GSM and sexual health.

Conditions

• Genitourinary Syndrome of Menopause
• Vulvovaginal Atrophy
• Menopause

Interventions

Type	Name	Description
DEVICE	Radiofrequency and pulsed electro-magnetic fields treatment	Radiofrequency and pulsed electro-magnetic fields treatment of the vaginal canal to maintain an internal temperature of approximately 42 C for the proximal thermometer and 45 C for the mid and distal thermometers for 15 minutes.

Timeline

• Start date: 2017-10-03
• Primary completion: 2020-05-31
• Completion: 2020-05-31
• First posted: 2020-10-29
• Last updated: 2020-10-29

Locations

1 site across 1 country: Ukraine