The Use of Laser in the Treatment of Atrophic Vulvovaginitis

Hospital Italiano de Buenos Aires

Status: Terminated

Conditions: Atrophy of Vagina; Lasers; Atrophy Vulva

Treatments: Procedure: Laser diiodo; Procedure: Laser Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04297319

5076

Details and patient eligibility

About

This study evaluates the efficacy and security of laser for atrophy treatment. Half of participants will receive the laser treatment and the other half placebo.

Full description

Thermal laser treatments are proposed as the newest treatments for atrophy. Through the thermal effect it would stimulates de mucosa, enhances the collagen component and the vascularization. Collagen remodeling and new collagen synthesis has been suggested as a mechanism of laser induced skin resurfacing and remodeling of vaginal connective tissue.

Enrollment: 20 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Menopause women with vulvovaginal symptoms of atrophy
• No previous estrogen treatment for the last 30 days
• Active sexual life (vaginal penetration)
• Accept to participate
• Pap atrophy or hypotrophy in the last year

Exclusion criteria

• Vulvovaginal diseases
• Abnormal uterine bleeding
• Antidepressants drugs
• Uncontrolled diabetes
• Cervical intraepithelial lesions or cancer
• Photosensitized or under treatment with photosensibilized drugs
• Collagen diseases
• Vulvovaginal infections in the last 15 days
• Immunosuppressed patients or under immunosuppressed treatments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

1 - Laser intervention

Experimental group

Description:

Laser diiodo treatment, 3 procedures of 5-10 minutes at intervals of 4 weeks

Treatment:

Procedure: Laser diiodo

2 - Laser placebo

Placebo Comparator group

Description:

Only the laser speculum is placed in the vagina but the laser is not activated. 3 procedures of 5-10 minutes at intervals of 4 weeks

Treatment:

Procedure: Laser Placebo