RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
Condition: Vulvovaginal Atrophy; Menopause; Menopause Surgical
Study type: Interventional

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.
    

Detailed 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 (Venus FioreTM CS0716 study, unpublished raw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.
    

Intervention name(s): Vulvovaginal Treatment
Intervention type(s): Device
Intervention description(s): Device model(s) - Venus Fiore™ Device settings and programming internal applicator - 42°C - 45°C Temperature output via automatic temperature control (ATC) (optional treatment).
Duration of exposure and frequency of exposure with internal applicator - one treatment for 12-15 minutes at 12 months (optional treatment).
Device settings and programming external mons pubis and labia applicators - 10-35% output (optional treatment).
Duration of exposure and frequency of exposure external applicators - one treament for 15 minutes for the mons pubis, 10 minutes for labia at 12 months (optional treatment).
Intervention model: Single Group Assignment
Intervention model description: Long term safety of the Venus Fiore Fiore™ (MP)2 system in improving vaginal laxity and skin laxity of the mons pubis and labia.
Subject's assessment of discomfort and pain as measured by a 10 cm visual analog scale (VAS) at 12 months if treatment (optional) is provided.
Subjects experiencing a treatment-related adverse event (AE) at six-months and twelve-months post-treatment.
Long term efficacy of the Venus Fiore Fiore™ (MP)2 system in improving vaginal laxity and skin laxity of the mons pubis and labia.
Improvement in vaginal laxity at six-months and twelve-months post-treatment compared to baseline as defined as a score >4 on the VLQ.
Improvement in FSFI mean score at six-months and twelve-months post-treatment compared to baseline.
Masking: None (Open Label)
Primary purpose: Other