Clinical Study to Compare the Efficacy of Erbium-Yag Laser or CO2RE Intimate Laser With Sham (COER)

Instituto Palacios136 enrolled

Overview

This trial compares the efficacy of two different laser treatments for vaginal atrophy symptoms between them and with sham treatment. Patients will be randomized to one of the two lasers or sham treatment.

Patients over 45 years of age with one or more AVV symptoms who wish to participate in the study will be included, 2 laser sessions spaced one of another 4-6 weeks, and final tracking visit 4-6 weeks of the last laser session. Each patient shall be randomly assigned an arm of tto, with laser CO2, or laser Erbium, or sham group

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

136

Conditions

Vaginal Atrophy

Interventions

CO2 intimateDEVICE

Two sessions with CO2 intimate laser for vaginal symptoms treatment

Erbium-yagDEVICE

Two sessions with Erbium-yag laser for vaginal symptoms treatment

CO2 intimate or Erbium-yagDEVICE

Two sessions of one of the two lasers with no therapeuthical energy

Eligibility

Sex: FEMALEMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women older than 45 years with at least one year of amenorrhea and at least one symptom of vulvovaginal atrophy of moderate and / or severe intensity. Exclusion Criteria: * Hormone treatment in the last three months for vulvovaginal atrophy * Treatment with vaginal moisturizers in the last week for vulvovaginal atrophy * Laser treatment in the last 12 months. * Acute and recurrent infections of the urinary tract in the last 3 months. * Acute genital infections * Vaginal prolapse * Alterations in the area to be treated, such as lacerations, abrasions or ulcers (time of resolution at medical discretion) * Chronic decompensated noncommunicable diseases * Women who are pregnant or have given birth in the last 3 months

Locations (1)

Instituto Palacios

Madrid, Spain

Outcomes

Primary Outcomes

Comparation of 1 series of 2 treatment sessions with Erbium-Yag or intimate CO2RE vs Sham for the symptoms of vulvovaginal atrophy

Analyzing the differences in % the cytological maturity index, changes in the intensity of symptoms and PH range of normality (3,5- 4.5).

Time frame: Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)

Secondary Outcomes

Differences between CO2RE and Erbium-Yag

Analyzing the differences in % the cytological maturity index, changes in the intensity of symptoms and PH range of normality (3,5- 4.5).

Time frame: Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)

Changes in the Vulvar and Vaginal Health Index (VVHI)

Analyzing the information registered in the visits performed

Time frame: Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)

Data from ClinicalTrials.gov

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