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

Vaginal Atrophy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04717245
• Other study ID #: CAI
• Status: Completed
• Phase: N/A
• Start date: October 25, 2018
• Est. completion date: February 18, 2020

Study information

• Verified date: August 2018
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 18, 2020
• Est. primary completion date: March 7, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Vaginal Atrophy

Intervention

Drug:
• 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.

Other:
• 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
• 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.

Locations

Country	Name	City	State
Brazil	Disciplina de ginecologia - departamento de ginecologia e obstetrícia - faculdade de medicina da USP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Life's quality questionnaire	It was acessed at the beginnig and in the end of the treatment. We used the Short Form Health Survey 36 questionnaire for this parameter. It contains 36 items measuring eight dimensions, that vary the pontuation between 1-5 to 1-6. All but one of the 36 items are used to score the SF-36 eight domains that are aggregated in two summary measures, Physical and Mental components. Among the eight domains, three scales (Physical Functioning, Role-Physical, and Bodily Pain) contributes mostly to the Physical Component Summary (PCS) and three (Mental Health, Role-Emotional, and Social Functioning) contributes to the Mental Component Summary. The domains Vitality, General Health, and Social Functioning present noteworthy correlations with both summary componentNormalized scores below 50 are interpreted as below the generals population. The better is to have a higher pontuation.	3-4 months
Secondary	Sexuality questionnaire - Female Sexual Function Index	This questionnaire analyses 6 parameters: desire, excitation, lubrication, orgasm, satisfaction and pain. Tha maximum pontuation for each parameter is 6, and for the entire questionnaire is 36 (the best pontuation).	3-4 months
Secondary	pH values	We used a pH tape to determine the vaginal pH. The normal measure é between 3,8 and 4,5.	3-4 months
Secondary	score symptoms	Patients describe these symptoms dryness, itching, burnig and pain as absent (0 points); mild :1 point; moderate : 2 points and severe : 3 points, at the begging and in the end of the treatment. The best pontuation is zero and the worst is 12.	3-4 months