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Clinical Trial Summary

Twelve month extension of a previous study of Multi-Polar RF and PEMF technologies for the treatment of vaginal laxity and for the treatment of the mons pubis and labia for improvement in skin laxity. The study will enroll up to 50 subjects who completed the Venus Fiore CS0716 study for the treatment of vaginal laxity and treatment of the mons pubis and labia for improvement in skin laxity. Subjects will be followed up at least six and twelve months post-treatment. Analysis will be performed on all subjects who complete the six-month and twelve month follow-up visits.

Clinical Trial Description

Traditional non-surgical treatments to treat vaginal laxity include Kegel exercises or pelvic floor therapy with electrical stimulation of the vaginal musculature to promote muscle strength. Although surgery to tighten the vaginal introitus has been used, pain at the incision site leading to dyspareunia, sometimes for months, limits its use. Surgery is also recommended to reduce protuberant mons pubis and the outer labial lips of the labia majora. Most often, the mons pubis has been treated by fat reduction, either by liposuction or open excision along with a pubic skin lift. Surgery to reduce the excess skin of the labia majora tends to be avoided due to a lack of operative techniques and a fear of creating sexual dysfunction. Development of alternative methods of treatment, avoiding the usual surgical complications is warranted. The use of non-ablative radiofrequency (RF) therapy has been used previously for the external and internal female genitalia without incident or complications. The use of Multi-Polar RF and PEMF technology was already demonstrated to be safe and efficient in delivering heat to the tissue. A previous study investigated the safety and efficacy of combining these technologies for the treatment of vaginal laxity and in the treatment of the mons pubis and labia for the improvement in skin laxity at four-months post-treatment. Efficacy and safety was confirmed up to 4-months post-treatment. (Venus FioreTM CS0716 study, unpublished raw data). However, the durability of the treatment is not known. This study will investigate whether Multi-Polar RF and PEMF technologies for the treatment of vaginal laxity and for the treatment of the mons pubis and labia is safe and efficacious at six-months and twelve-months post-treatment. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04210583
Study type Interventional
Source Venus Concept
Status Completed
Phase N/A
Start date September 4, 2019
Completion date December 31, 2022

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