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.
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. The aim of the current study is to evaluate the effect of Pixel CO2 laser, (FemiLiftTM), for the treatment of VVA, on the clinical and molecular levels.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Pixel CO2 Laser for the Treatment of Vulvo-Vaginal Atrophy (VVA)
Hille Yaffe Medical Center
Hadera, Israel
RECRUITINGTo 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)
Time frame: Two years
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.
Time frame: Two years
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