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

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ClinicalTrials.gov Identifier: NCT03939078
Recruitment Status : Completed
First Posted : May 6, 2019
Last Update Posted : September 9, 2020
Sponsor:
Collaborator:
Alma Lasers
Information provided by (Responsible Party):
Maria Claudia Almeida Issa, Universidade Federal Fluminense

Study Description
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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.

Condition or disease Intervention/treatment
Menopause Vaginal Atrophy Urinary Incontinence Radiation: CO2 fractional ablative laser

Study Design
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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Fractional Ablative CO2 Laser in the Treatment of the Genitourinary Syndrome of Menopause
Actual Study Start Date : April 5, 2018
Actual Primary Completion Date : October 5, 2019
Actual Study Completion Date : March 5, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939078


Locations
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Brazil
Hospital Universitario Antonio Pedro
Niteroi, Rio De Janeiro, Brazil, 24033-900
Sponsors and Collaborators
Universidade Federal Fluminense
Alma Lasers
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Maria Claudia Almeida Issa, Professor, Universidade Federal Fluminense
ClinicalTrials.gov Identifier: NCT03939078    
Other Study ID Numbers: CO2 laser
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Maria Claudia Almeida Issa, Universidade Federal Fluminense:
menopause
vaginal atrophy
urinary incontinence
CO2 laser
 fractional laser
dyspareunia
vaginal dryness
vaginal lubrication
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Atrophy
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
 Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Pathological Conditions, Anatomical