The Use of Laser in the Treatment of Atrophic Vulvovaginitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-20

Study Completion Date

2021-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lasers Atrophy of Vagina Atrophy Vulva

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind, randomized, control clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The patient and the outcomes assessor and principal investigator has not access to the randomization system

Study Groups

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1 - Laser intervention

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

Group Type EXPERIMENTAL

Laser diiodo

Intervention Type PROCEDURE

3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks It is an outpatient procedure, not anesthesia required.

2 - Laser placebo

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

Group Type PLACEBO_COMPARATOR

Laser Placebo

Intervention Type PROCEDURE

3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks. It is an outpatient procedure, not anesthesia required.

Interventions

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Laser diiodo

3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks It is an outpatient procedure, not anesthesia required.

Intervention Type PROCEDURE

Laser Placebo

3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks. It is an outpatient procedure, not anesthesia required.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No