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 Sexual Function-Vaginal Changes Questionnaire. Scores equal to or less than 24 points will result in an impact on quality of life. A rise of 3 or more points is considered a significant improvement. The severity levels of quality of life impairment will be as follows: * Mild (scores between 24 and 17) * Moderate (scores between 16 and 8) * Severe (scores between 7 and 1)
Changes in vulvar physical examination
We will use the following measurement system: Vulvar Health Index Score. It is based on the macroscopic inspection of the vulva performed through a colposcope. The scores range from 0 to 24, being higher to greater atrophy. It is considered a diagnosis of atrophy scores greater than 8 or having obtained 3 points in any of the items. The degrees of gravity are set as follows: 1. Between 9 and 14 points, mild 2. Between 15 and 20 points, moderate 3. Between 21 and 24 points, severe. A reduction of 3 or more points in the overall score or at least one point will be considered a favorable response if there has been an item with a score of 3.
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.
Presence of bladder hyperactivity clinic
The following questionnaires will be used: Bladder control self-assessment questionnaire. This scale measures 2 items: Presence of symptoms and discomfort generated by them. The range of values for each of them goes from 0 to 12, with the severity levels being the following in both cases: 0--\>Absence of symptoms/discomfort. 1-3--\>Mild symptoms/discomfort. 4-6--\>Moderate symptoms/discomfort. 7-9--\>Severe symptoms/discomfort. 10-12--\>Very serious symptoms/discomfort.
Presence of urge urinary incontinence
The Sandvik Test will be used. It consists of 2 sections whose scores are multiplied. The range of scores goes from 0 to 12, with the only possible values being 0, 1, 2, 3, 4, 6, 8, 9 and 12. The degree of urinary incontinence shall be classified as follows: 0--\>Absence of incontinence 1-2--\>Mild urinary incontinence 3-6--\>Moderate urinary incontinence 8-9--\>Severe urinary incontinence 12--\>Very severe urinary incontinence
Impact of urinary incontinence on quality of life
We will use the International Consultation on Incontinence Questionnaire-Short Form. Of this scale we will only use in section that measures the degree of discomfort caused by incontinence and that reaches the values of 1 to 10.
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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Lead sponsor
Lumenis Be Ltd.
Collaborator
Mucosa Innovations, S.L.
Collaborator
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