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

• Status: Completed
• Trial end date: 2020-02-18
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo General Hospital

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