Comparative Study: Vaginal Promestriene Use, Fractional CO2 LASER and Radiofrequency in the Vaginal Atrophy Treatment
Condition: Vaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional

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.
    

Intervention name(s): Promestriene Vaginal; Fractional CO2 LASER; Microablative Fractional radiofrequency
Intervention type(s): Drug; Other; Other
Intervention description(s): Patients used promestriene vaginal cream for 3 months. The use was recommended to be diary fot the first 2 weeks, and then, repeat every 3 days.; LASER treatment with fractional CO2 Laser was performed in 3 sessions with intervals of 4 weeks between them. Before each session, the patients underwent specular examination.
Fractional CO2 LASER was applied following these parameters, fixed in all sessions: vagina wall - power40 W, dwel time 1000 mcs, spacing 1000 mcm and stack 2, vestibule - power 10W, dwel time 500mcs, spacing 300mcg and satck 1; Microablative fractional radiofrequency was performed with the equipment calibrated in FRAXX mode, 45W, Low Energy program 40 milliseconds in the vaginal and introitus wall. Lidocaine spray was applied to vaginal introitus before the procedure.
The patient was in the gynecological position. The vaginal speculum was placed and, afterwards, the vaginal antisepsis was performed with aqueous chlorhexidine and cleaning with 0.9% saline solution.
All liquid contents were wiped off before beginning the procedure. The fractured tip will be pressed lightly and as perpendicular as possible into the vulvar or vaginal surface, ensuring full contact of all points in the tissue, starting at the lateral vaginal walls and from the proximal to the distal third.
Other intervention name(s): Promestrieno
Allocation: Randomized
Intervention model: Parallel Assignment
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
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: genital atrophy; fractional CO2 laser; microablative fractional radiofrequency; quality of life; sexuality; promestriene; Menopause genitourinary syndrome