Use of Fractional CO2 Laser for the Treatment of Vulvovaginal Atrophy: a Double-blinded Randomized Placebo-controlled Clinical Trial.

Use of Fractional CO2 Laser for the Treatment of Vulvovaginal Atrophy: a Double-blinded Randomized Placebo-controlled Clinical Trial.

Purpose of the trial is to study the efficacy of fractional laser in alleviating genitourinary symptoms in menopausal women.

Primary outcome of the study is the efficacy of the laser procedure, intended as the amelioration of the severity of most bothersome symptom (MBS).

Therefore we conducted a single center, double-blinded randomized placebo-controlled cross-over trial.

Inclusion Criteria:

Healthy women with menopausal status (>1 year amenorrhea) AND with moderate to severe symptoms of VVA as measured by the MBS score ≥2.

Exclusion Criteria:

• Acute or recurrent urogenital infections
• Prolapse ≥ grade 3 according to the Pelvic Organ Prolapse Quantification System
• Hormonal replacement therapy within the last 6 months before study entry
• Use of local estrogens, moisturizers, lubricants or homeopathic preparations within the last 3 months
• Pelvic floor physiotherapy for pelvic floor disorders within the last 3 months
• Any condition that could interfere with study compliance