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

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.

Conditions

• Vaginal Atrophy

Interventions

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

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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital

  lead OTHER

Principal Investigators

• Jose Maria Soares Junior, PHD · Universidade de São Paulo departamento de ginecologia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-25

Primary Completion

2019-03-07

Completion

2020-02-18

Countries

• Brazil

Study Locations