Clinical trial NCT04717245: Comparative Study: Vaginal Promestriene Use, Fractional CO2 LASER and Radiofrequency in the Vaginal Atrophy Treatment
Official title: Comparative Study : The Effect of Vaginal Estrogen Use, Fractional CO2 LASER and Microablative Fractional Radiofrequency in the Treatment of Vaginal Atrophy: Clinical, Histological, Immunohistochemical and Molecular Biology Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Atrophy
Keywords: genital atrophy
fractional CO2 laser
microablative fractional radiofrequency
quality of life
sexuality
promestriene
Menopause genitourinary syndrome
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 75
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, 75 patients were included, divided into these three groups:

Group 1 - Treatment with topical vaginal promestriene - 25 patients were included in this group

Group 2 - Treatment with fractional CO2 LASER - 25 patients were included in this group

Group 3 - Treatment with microablative fractional radiofrequency - 25 patients were included in this group
Primary purpose: TREATMENT

Brief summary: Postmenopausal hypoestrogenism may determine genital atrophy, which may be accompanied by a non-specific inflammatory process and may hinder or even prevent sexual intercourse. In more severe cases, the patient may have local pain that interferes with their daily activities. The best treatment for increasing genital trophism is still estrogen. However, there are women who can not use this therapy or do not want it. Therefore, there is a need for alternatives, such as ablation techniques: use of CO2 LASER and fractional radiofrequency.

The study was carried out at the outpatient clinic of Lower Genital Tract ambulatory of the Discipline of Gynecology, Department of Obstetrics and Gynecology, Clinical Hospital, Faculty of Medicine, University of São Paulo, involving 75 women who were divided after randomization in three groups:

Group 1 - treatment with topical vaginal promestriene (n = 25 patients); Group 2 - treatment with fractional CO2 LASER (n = 25 patients); Group 3 - fractional microablative radiofrequency treatment (n = 25 patients).

An evaluation of the complaints were be performed through questionnaires on sexuality, quality of life and urinary incontinence, as well as biopsies of the vaginal wall for histomorphometric, immunohistochemical and molecular biology study before and after six months of treatment. The duration of the study were fifteen months.

Detailed description: After completing the eligibility criteria, patients signed the consent inform.

Division of groups:

Were included in the study 75 patients, divided into three groups:

Group 1 - Treatment with topical vaginal promestriene - 25 patients in this group were included patients free of systemic or topical hormonal treatment for at 3 months

Group 2 - Treatment with CO2 LASER - 25 patients, in this group were included patients free of systemic or topical hormonal treatment for at 3 months.

Group 3 - Treatment with microablative fractionated radiofrequency - 25 patients in this group were included patients free of systemic or topical hormonal treatment for at least 3 months.

The present study was open and randomized. The randomization was be performed through the software "Test Generator Software Standard Edition"

At the first visit, all patients responded to the clinical questionnaire of female sex quotient (QS-F), the quality of life questionnaire (SF-36) and the urinary incontinence questionnaire.

All patients were submitted to specular gynecological examination to collect cervical-vaginal cytology, biopsy of 1/3 proximal vaginal wall for histological analysis and immunohistochemistry.

After the results of the examinations and possible treatments required, the patients were referred for the proposed treatments according to their randomized group.

Sampling Cytology :Cervical and vaginal oncology cytology were collected through a smear on a slide with fixative.

The histological expression of the following immunohistochemical parameters will be evaluated:

* Presence and density of estrogen receptors
* Vascular density
* Thickness of the epithelium
* Density of collagen fibers
* Vaginal microbiota
* Vaginal pH

In this study, it will be done a Morphological Analysis, a Histomorphometric analysis and e Immunohistochemical analysis.

Eligibility criteria: Inclusion Criteria:

Age equal or superior to 40 years and under 65 years

* Clinical menopause - last menstrual period from 1 to 5 years from the date of recruitment
* FSH measurement\> 25 IU / ml, estrogen \<20 æg / ml
* Patients with vaginal atrophy and clinical and / or sexual symptoms
* Patients without hormonal treatment for at least five years

Exclusion Criteria:

* Whole Hymen

  * Altered oncology cytology of the cervix and / or vagina
  * Vaginal infections
  * Connective tissue diseases
  * Immunosuppression
  * Coagulation change
  * Diabetes Mellitus
  * Thyroid diseases
  * Use of systemic or local feminine hormones
  * Use of other substances with estrogenic properties

Primary outcomes:
measure: Life's quality questionnaire
timeFrame: 3-4 months
Secondary outcomes:
measure: Sexuality questionnaire - Female Sexual Function Index
timeFrame: 3-4 months
measure: pH values
timeFrame: 3-4 months
measure: score symptoms
timeFrame: 3-4 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Disciplina de ginecologia - departamento de ginecologia e obstetrícia - faculdade de medicina da USP
Study officials:
affiliation: Universidade de São Paulo departamento de ginecologia
name: Jose Maria Soares Junior, PHD
role: STUDY_DIRECTOR
References: