Vulvo Vaginal Atrophy (VVA) refers to the changes in the vaginal and vulvar surfaces that occurs during menopause due to the progressive loss of estrogen. The low levels of circulating estrogen produce a wide variety of anatomic, physiologic, and clinical changes in the urogenital area. Clinical symptoms include vaginal dryness, irritation, soreness, dyspareunia, dysuria, and vaginal discharge.
In recent years, microablative fractional CO2 laser has become available for treating vaginal atrophy. It showed a regenerative property with significant histological changes in cellular and connective tissue components. Treatment with the fractional CO2 laser resulted in restoration of the vaginal epithelium with ultrastructural findings, similar to a premenopausal state, that included thickened stratified squamous epithelium with increased collagen support, increased glycogen in epithelial cells, increased fibroblasts, increased vascularity, and presence of sub-epithelial papillae.
Female 45-75 years of age, at the time of enrolment.
Provided written informed consent.
Amenorrhea of ≥12 months
After bilateral oophorectomy
Vaginal Health Index Score (VHIS) < 5.
Active genital infection.
Vaginal bleeding which did not underwent evaluation.
Previous vulvar, vaginal or cervical dysplasia, within the last 2 years, or previous cancer.
Single group
Pixel CO2 Laser for the Treatment of Vulvo-Vaginal Atrophy (VVA)
DevicePixel CO2 Laser for the Treatment of Vulvo-Vaginal Atrophy (VVA)
To evaluate the efficacy of Pixel CO2 laser (FemiLift™) for the treatment of VVA via the patient symptoms and complaints.
The efficacy of Pixel CO2 laser (FemiLift™) treatment will be evaluate by: 1. Improvement in VVA symptoms (itching, burning, dryness, dyspareunia, and dysuria) as evaluated by the subject, using a Numeric Rating Scales (NRSs) of 0-10. 2. Improvement in sexual function as evaluated by the subject, using the Female Sexual Function Index (FSFI)
To evaluate gene expression following the FemiLiftTM treatment
Changes in gene expression profile, 2 weeks following the third FemiLiftTM treatment (Tx3), compared to baseline. The list of genes chosen for RT PCR following a CO2 laser treatment on vaginal mucosa, includes genes taken from the following biological pathways: inflammatory response, wound healing, extracellular remodeling and connective tissue formation.
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