Use of Fractional CO2 Laser for the Treatment of Vulvovaginal Atrophy: a Double-blinded Randomized Placebo-controlled Clinical Trial. (CO2VVA)

prof. dr. Jan Deprest

Status: Completed

Conditions: Vulvovaginal Atrophy

Treatments: Procedure: Vaginal laser application

Study type: Interventional

Funder types: Other

Identifiers

NCT04021966

S61680

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Laser

Experimental group

Description:

In this arm, participants will have 3 real laser treatments first, followed by 3 consecutive sham treatments.

Treatment:

Procedure: Vaginal laser application

Sham

Sham Comparator group

Description:

In this arm, participants will have 3 sham treatments first, followed by 3 consecutive real laser treatments.

Treatment:

Procedure: Vaginal laser application