Comparative Study: Vaginal Promestriene Use, Fractional CO2 LASER and Radiofrequency in the Vaginal Atrophy Treatment

NCT ID: NCT04717245

Last Updated: 2021-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-25
• Study Completion Date: 2020-02-18

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.

Conditions

Vaginal Atrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fractional CO2 LASER

Vaginal fractional CO2 LASER 3 sessions applications

Group Type: ACTIVE_COMPARATOR

Fractional CO2 LASER

Intervention Type: OTHER

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

Vaginal Microablative fractional radiofrequency 3 sessions application

Group Type: ACTIVE_COMPARATOR

Microablative Fractional radiofrequency

Intervention Type: OTHER

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.

Promestriene Vaginal

Promestriene vaginal use during 3 months

Group Type: ACTIVE_COMPARATOR

Promestriene Vaginal

Intervention Type: DRUG

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.

Interventions

Promestriene Vaginal

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.

Intervention Type: DRUG

Fractional CO2 LASER

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

Intervention Type: OTHER

Microablative Fractional radiofrequency

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.

Intervention Type: OTHER

Other Intervention Names

Promestrieno

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose Maria Soares Junior, PHD

Role: STUDY_DIRECTOR

Universidade de São Paulo departamento de ginecologia

Locations

Disciplina de ginecologia - departamento de ginecologia e obstetrícia - faculdade de medicina da USP

São Paulo, , Brazil

Countries

Brazil

References

Seganfredo IB, Bianchi C, Tacla M, Chedraui P, Haddad JM, Simoes R, Baracat EC, Soares JM Jr. Comparison of promestriene with vaginal fractional CO2 laser and radiofrequency treatments of genitourinary syndrome of menopause. Maturitas. 2024 Aug;186:108008. doi: 10.1016/j.maturitas.2024.108008. Epub 2024 Apr 24.

Reference Type: DERIVED

PMID: 38714422 (View on PubMed)

Other Identifiers

CAI

Identifier Type: -

Identifier Source: org_study_id