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

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Vulvovaginal Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Laser

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

Group Type EXPERIMENTAL

Vaginal laser application

Intervention Type PROCEDURE

One laser treatment cycle consists of 3 vaginal laser applications with a 4-weeks interval. Each application lasts around 5 minutes.

The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators.

A vaginal probe will be gently inserted and manually rotated to provide a 360° treatment of the vaginal mucosa.

Sham

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

Group Type SHAM_COMPARATOR

Vaginal laser application

Intervention Type PROCEDURE

One laser treatment cycle consists of 3 vaginal laser applications with a 4-weeks interval. Each application lasts around 5 minutes.

The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators.

A vaginal probe will be gently inserted and manually rotated to provide a 360° treatment of the vaginal mucosa.

Interventions

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Vaginal laser application

One laser treatment cycle consists of 3 vaginal laser applications with a 4-weeks interval. Each application lasts around 5 minutes.

The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators.

A vaginal probe will be gently inserted and manually rotated to provide a 360° treatment of the vaginal mucosa.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes