NCT03725410

Multi-polar RF and PEMF for Treatment of Symptoms Associated With Vulvovaginal Atrophy

Clinical Evaluation of the Safety and Performance 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: 81 (actual)
• Sponsor: Venus Concept · Industry
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter, single-blind, randomized, sham-controlled study utilizing the Venus Fiore™ (MP)2, a table-top device designed to deliver multi-polar RF energy and pulsed electromagnetic fields for use in dermatological and general surgical procedures to temporarily improve blood circulation and to induce modification of collagen structure, neocollagenesis and angiogenesis for the treatment of symptoms associated with vulvovaginal atrophy.

Detailed description

Multicenter, single-blind, randomized, sham-controlled study of multi-polar radio-frequency (RF) and pulsed electro-magnetic field (PEMF) technologies for the treatment of symptoms associated with vulvovaginal atrophy. The study will enroll up to 106 subjects requesting treatment of symptoms of vulvovaginal atrophy (vaginal dryness, decreased lubrication during sexual activity, decreased elasticity, irritation, discomfort during intercourse and discomfort of the vaginal and vulvar tissues in general) in order to have 88 subjects complete the study. Subjects will be randomized in a 1:1 ratio to either multi-polar RF and PEMF technologies or sham treatment and will receive a total of three internal and external treatments with the Venus Fiore™ (MP)2 device at four-week intervals. Study treatment will be administered as per the parameter recommendations as set out in the Venus Fiore™ (MP)2 user manual. Subjects will be followed up at three and six months after their initial treatment. Analysis will be performed on all subjects who receive at least one treatment. Three- and six-month outcomes from the active arm will be compared to data from the sham arm.

Conditions

• Vulvovaginal Atrophy

Interventions

Type	Name	Description
DEVICE	Venus Fiore Study Treatment	Study treatment consists of delivering radiofrequency (RF) and pulsed electromagnetic fields (PEMF) internally to the vagina (50 - 70% for up to 15 minutes), externally to the labia (10 - 35% for up to 10 minutes) and externally to the mons pubis (10 - 35% for up to 15 minutes).
DEVICE	Venus Fiore Sham Treatment	Sham treatment consists of delivering radiofrequency (RF) and pulsed electromagnetic fields (PEMF) internally to the vagina (1% for up to 15 minutes), externally to the labia (1% for up to 10 minutes) and externally to the mons pubis (1% for up to 15 minutes).

Timeline

• Start date: 2018-09-25
• Primary completion: 2022-09-30
• Completion: 2022-12-31
• First posted: 2018-10-31
• Last updated: 2023-06-02

Locations

2 sites across 2 countries: Italy, Spain