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

September 6, 2020 updated by: Maria Claudia Almeida Issa, Universidade Federal Fluminense

Fractional Ablative CO2 Laser in the Treatment of the Genitourinary Syndrome of Menopause

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio De Janeiro
      • Niteroi, Rio De Janeiro, Brazil, 24033-900
        • Hospital Universitario Antonio Pedro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Volunteer women from 40 to 70 years, healthy and with regular gynecologist follow up, not willing or not eligible to take hormones to treat the GSM, experimenting difficulties in their sexual life and their daily routine, due to vaginal atrophy and urinary incontinence.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vaginal Laser Intervention
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.
Radiation: CO2 fractional ablative laser
3 intravaginal fractional ablative CO2 laser sessions, with one month interval between them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reversion of vaginal atrophy
Time Frame: 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.
1 month after the last (3rd) laser section
Improvement in urinary incontinence
Time Frame: 1 month after the third and last laser section
Improvement in urine involuntary loss, the so called stress incontinence
1 month after the third and last laser section

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal Fluminense

Collaborators

Alma Lasers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2018

Primary Completion (Actual)

October 5, 2019

Study Completion (Actual)

March 5, 2020

Study Registration Dates

First Submitted

April 23, 2019

First Submitted That Met QC Criteria

May 2, 2019

First Posted (Actual)

May 6, 2019

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 6, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO2 laser

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urinary Incontinence

Clinical Trials on CO2 fractional ablative laser

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe