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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03939078
Enrollment
14
Registered
2019-05-06
Start date
2018-04-05
Completion date
2020-03-05
Last updated
2020-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause, Urinary Incontinence, Vaginal Atrophy

Keywords

menopause, vaginal atrophy, urinary incontinence, CO2 laser, fractional laser, dyspareunia, vaginal dryness, vaginal lubrication

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.

Interventions

3 intravaginal fractional ablative CO2 laser sessions, with one month interval between them.

Sponsors

Alma Lasers
CollaboratorINDUSTRY
Universidade Federal Fluminense
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Reversion of vaginal atrophy1 month after the last (3rd) laser sectionReversion of vaginal atrophy by the laser stimulation, with increasing layers of epithelial cells, increased collagen deposition and improvement in vascularization.
Improvement in urinary incontinence1 month after the third and last laser sectionImprovement in urine involuntary loss, the so called stress incontinence

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026