Vaginal CO2 Laser and the Genitourinary Syndrome of Menopause

National and Kapodistrian University of Athens

Status: Unknown

Conditions: Vaginal Atrophy

Treatments: Device: Microablative Fractional CO2 laser

Study type: Interventional

Funder types: Other

Identifiers

NCT03754205

674/03-09-2018

Details and patient eligibility

About

This study evaluates the clinical, histopathological, cytological and microbiological efficacy of Microablative Fractional CO2 laser intravaginally administered in postmenopausal women with Genitourinary Syndrome of Menopause. Half participants will receive active CO2 laser therapy, while the other half will receive placebo CO2 laser therapy.

Enrollment: 60 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Symptoms of vaginal atrophy (dyspareunia and/or vaginal dryness)
• Menopause

Exclusion criteria

• Systemic or local hormonal therapy the last 6 months
• Use of moisturizers or lubricants the last month
• Active genital infection (i.e herpes, vaginitis)
• Prolapse stage >=2
• Underlying pathologies that could interfere with the protocol compliance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups, including a placebo group

Laser Group

Experimental group

Description:

Microablative Fractional CO2 laser therapy at monthly intervals. The laser parameters that will be used are the following: (1) Power: 30 ή 40 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter from 1-3 depending on the treatment status, 5) D-pulse mode.

Treatment:

Device: Microablative Fractional CO2 laser

Placebo Group

Placebo Comparator group

Description:

Placebo CO2 laser therapies at monthly intervals. The laser parameters that will be used are the following: 1) Power: 0.5 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter 1, 5) Smart-pulse mode.

Treatment:

Device: Microablative Fractional CO2 laser