CO2 Laser in the Treatment of the GSM - (Genitourinary Syndrome of Menopause) Genitourinary Syndrome of Menopause

Completed

• Conditions: Urinary Incontinence; Vaginal Atrophy; Menopause
• Interventions: Radiation: CO2 fractional ablative laser

• Registration Number: NCT03939078
• Lead Sponsor: Universidade Federal Fluminense

Brief Summary

Menopause is a woman's hormonal status one year after her ovulatory failure, when the decrease of circulating estrogen levels leads to a group of symptoms named Genitourinary Syndrome of Menopause (GSM), such as: vaginal dryness, dyspareunia, dysuria, epithelial fragility with recurrent bleedings, loss of genital elasticity and pH alterations causing recurrent infections. The CO2 laser is a fractional ablative source of light, capable of inducing neocollagenesis within the skin, reversing atrophies, increasing blood supply and reorganizing the architectural structure of the treated epithelium. Recent studies in the laser field show great improvement of the SGM, with satisfying results in female's sexual disfunction. Nevertheless, there is still a lack of studies that show, at the same time, the improvement in both patient's subjective reports and objective measurements, such as cytology, histology and immunohistochemistry. This study aims to thoroughly analyze the benefits of the CO2 laser in the treatment of the GMS, comparing the improvement found in questionnaires to the results of cytology, histology and immunohistochemistry for collagen I and III from vaginal biopsies before and after the laser treatment. Therefore, fourteen women after menopause complaining of symptoms of the GSM were selected from the ambulatory of the Hospital Universitário Antônio Pedro. The patients will be submitted to three CO2 intravaginal laser (Femilift®), with a 30-days interval between them. Biopsies of the vaginal wall will be taken one month before the start and one month after the end of the laser sessions, and material will be sent to histology, cytology and immunohistochemistry analysis. Results obtained will be compared to the patients' reports, in order to evaluate subjective and objective improvement due to the treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-05
• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-06
• Primary Completion: 2019-10-05
• Study Completion: 2020-03-05
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-06
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

Inclusion Criteria

• Women from 40 to 70 years old;
• Post- menopausa (at least one year after cessation of periods);
• Experimenting any symptom related to the Genitourinary Syndrome of Menopause (GSM), such as: vaginal dryness, dyspareunia, urinary incontinence, dysuria, recurrent urinary infections;
• Regular follow up in gynecologist, with recent normal pap smear.

Exclusion Criteria

• The volunteers must not be under any treatment for this syndrome;
• Volunteers cannot be using hormones or any vaginal treatment;
• Volunteers cannot have previous history of vaginal / uterine cancer;
• Volunteers cannot have previous surgery for urinary incontinence;
• Uterine prolapse;
• Recent altered pap smear.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vaginal Laser Intervention	CO2 fractional ablative laser	Patients will be submitted to vaginal biopsy before and after three laser sections, and therefore will be their own comparative group to see the improvement associated with the laser effects.

Primary Outcome Measures

Name	Time	Method
Reversion of vaginal atrophy	1 month after the last (3rd) laser section	Reversion of vaginal atrophy by the laser stimulation, with increasing layers of epithelial cells, increased collagen deposition and improvement in vascularization.
Improvement in urinary incontinence	1 month after the third and last laser section	Improvement in urine involuntary loss, the so called stress incontinence

Trial Locations

Locations (1)

Hospital Universitario Antonio Pedro; 🇧🇷 Niteroi, Rio De Janeiro, Brazil