The genito-urinary syndrome of menopause severely affects patients with a history of gynecological cancer, especially those diagnosed with breast cancer. At the present time, we do not have solid scientific evidence on treatments that can be effective and safe to address this pathology. Based on the above, we have developed our working hypothesis where it is postulated that the microfractionated laser treatment of C02, in conjunction with topical regenerative treatment, constitute an effective alternative in the management of vulvo-vaginal atrophy in oncological patients who have contraindicated hormonal treatments.
Patients over 18 years of age
Who have a history of breast malignancy, and are on adjuvant or neoadjuvant treatment with hormone therapy.
That they suffer symptoms related to vulvo-vaginal atrophy and thus become evident to the gynecological examination (Vaginal Health Index<ó=15).
That this clinic significantly affects your quality of life ( score in Sexual Function-Vaginal Changes Questionnaire less than or equal to 24 points).
Medical or surgical history that at the discretion of the researcher does not allow participation in the study.
Refusal to participate in the study and to sign consent.
Be on chemotherapy treatment at the time of inclusion in the study.
Have completely completed the adjuvant hormonal treatment.
Parallel
C02 microablative laser
DeviceThe C02 microablative laser was the first to be used in the treatment of menopausal genitourinary syndrome. Its mechanism of action is based on the emission of light at a wavelength of 10600nm that is absorbed by the water molecules contained in the vaginal mucosa, leading to local remodeling of connective tissue and neoformation of collagen, elastic fibers and other components of the extracellular matrix.
Regenerative topical treatment
Combination productIt is a moisturizing and regenerating gel whose active ingredients are olive oil, trimethylglycine and xylitol.
Presence of symptoms at the vulvovaginal level and their intensity
This group will include the following items: * Pain with sexual intercourse (dyspareunia). * Feeling of vaginal stiffness. * Dryness. * Vulvar itching. * Vulvar and/or vaginal burning. * Urinary frequency (more than 8 times a day). * Burning when urinating (dysuria). The way to measure the intensity of these symptoms will be through Visual Analog Scale Of Symptom Intensity, with absolute values ranging from 0 to 10. We will consider improvement a reduction of 2 or more points in at least 50% of the items. Meeting only this item is already considered an efficacy criterion.
Impact in the quality of life of vulvo-vaginal symptoms.
The tool used will be the Day-to-Day impact of Vaginal Aging (DIVA) Questionnaire. This questionnaire covers four domains: * Activities of daily living * Sexual activity * Emotional well-being * Self-concept and body image Each domain, in turn, consists of several questions. The score for each domain is calculated as the mean of the scores obtained for the questions comprising that domain. The total questionnaire score is, in turn, calculated as the mean of the scores for each domain. Therefore, the total score ranges from 0 to 4 points. The categories assigned to each score value are as follows: 0 = No impairment 1. = Minimal impairment 2. = Moderate impairment 3. = Considerable impairment 4. = Extreme impairment A reduction of at least one point in the final score will be considered a clinically significant improvement.
Changes in vaginal physical examination
We will use the following measurement systems: Vaginal Health Index Score. It is based on the macroscopic inspection of the vagina performed through a colposcope. Scores range from 5 to 25 points (scores equal to or less than 15 are considered diagnostic of atrophy). It is carried out by assessing different items related to exploratory findings. We can categorize the scores into different degrees of severity of vulvo-vaginal atrophy objectified to the examination: 1. \>from 15 points, absence of atrophy 2. Between 15 and 13 points, mild 3. Between 12 and 9 points, moderate 4. Between 8 and 5 points, severe An increase of 2 or more points in the overall score will be considered a favourable response.
Histological Changes in Vaginal Mucosa
Samples will be collected by obtaining vaginal mucosal biopsies using a 4-mm punch biopsy instrument. The histological assessment will include the following: Hematoxylin and eosin (H\&E) staining: overall assessment of the sample and measurement, in micrometers, of the vaginal mucosal epithelial thickness. Vaginal Maturation Index (VMI): percentage of superficial, intermediate, and parabasal epithelial cells. Periodic Acid-Schiff (PAS) staining: quantification of cellular glycogen and qualitative assessment of the degree of hyalinization on a 0-3 scale. Orcein staining: qualitative assessment of the density of elastic fibers on a 0-3 scale. Collagen quantification using Masson's trichrome staining. The immunohistochemical assessment will include: CD31: quantitative assessment of the number of capillaries per ×40 microscopic field. Three measurements will be performed in the most representative fields, and the mean value will be calculated.
Microbiological Assessment of the Vaginal Ecosystem
Samples will be collected by obtaining vaginal swabs. The following assessments will be performed: * Microscopic examination for the diagnosis of bacterial vaginosis. * Molecular identification by PCR and MALDI-TOF analysis of isolated colonies of: Lactobacilli, including differentiation of: Lactobacillus crispatus Lactobacillus jensenii Lactobacillus gasseri Candida spp. Gardnerella vaginalis --\>Measurement of the pH of the sample
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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Lead sponsor
Lumenis Be Ltd.
Collaborator
Mucosa Innovations, S.L.
Collaborator
