CO2 Laser in the Treatment of the GSM - (Genitourinary Syndrome of Menopause) Genitourinary Syndrome of Menopause

Study Overview
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Brief Summary
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Menopause is a woman's hormonal status one year after her ovulatory failure, when the decrease of circulating estrogen levels leads to a group of symptoms named Genitourinary Syndrome of Menopause (GSM), such as: vaginal dryness, dyspareunia, dysuria, epithelial fragility with recurrent bleedings, loss of genital elasticity and pH alterations causing recurrent infections. The CO2 laser is a fractional ablative source of light, capable of inducing neocollagenesis within the skin, reversing atrophies, increasing blood supply and reorganizing the architectural structure of the treated epithelium. Recent studies in the laser field show great improvement of the SGM, with satisfying results in female's sexual disfunction. Nevertheless, there is still a lack of studies that show, at the same time, the improvement in both patient's subjective reports and objective measurements, such as cytology, histology and immunohistochemistry. This study aims to thoroughly analyze the benefits of the CO2 laser in the treatment of the GMS, comparing the improvement found in questionnaires to the results of cytology, histology and immunohistochemistry for collagen I and III from vaginal biopsies before and after the laser treatment. Therefore, fourteen women after menopause complaining of symptoms of the GSM were selected from the ambulatory of the Hospital Universitário Antônio Pedro. The patients will be submitted to three CO2 intravaginal laser (Femilift®), with a 30-days interval between them. Biopsies of the vaginal wall will be taken one month before the start and one month after the end of the laser sessions, and material will be sent to histology, cytology and immunohistochemistry analysis. Results obtained will be compared to the patients' reports, in order to evaluate subjective and objective improvement due to the treatment.

Official Title
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Fractional Ablative CO2 Laser in the Treatment of the Genitourinary Syndrome of Menopause

Conditions
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Menopause, Vaginal Atrophy, Urinary Incontinence

Intervention / Treatment
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* Radiation: CO2 fractional ablative laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women from 40 to 70 years old; Post- menopausa (at least one year after cessation of periods); Experimenting any symptom related to the Genitourinary Syndrome of Menopause (GSM), such as: vaginal dryness, dyspareunia, urinary incontinence, dysuria, recurrent urinary infections; Regular follow up in gynecologist, with recent normal pap smear. Exclusion Criteria: The volunteers must not be under any treatment for this syndrome; Volunteers cannot be using hormones or any vaginal treatment; Volunteers cannot have previous history of vaginal / uterine cancer; Volunteers cannot have previous surgery for urinary incontinence; Uterine prolapse; Recent altered pap smear.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vaginal Laser Intervention<br>Patients will be submitted to vaginal biopsy before and after three laser sections, and therefore will be their own comparative group to see the improvement associated with the laser effects. | Radiation: CO2 fractional ablative laser<br>* 3 intravaginal fractional ablative CO2 laser sessions, with one month interval between them.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reversion of vaginal atrophy | Reversion of vaginal atrophy by the laser stimulation, with increasing layers of epithelial cells, increased collagen deposition and improvement in vascularization. | 1 month after the last (3rd) laser section | 
| Improvement in urinary incontinence | Improvement in urine involuntary loss, the so called stress incontinence | 1 month after the third and last laser section | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menopause, vaginal atrophy, urinary incontinence, CO2 laser, fractional laser, dyspareunia, vaginal dryness, vaginal lubrication