CO2 Laser vs Lidocaine for Vestibulodynia in Premenopausal Women

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-01-31

Brief Summary

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CO2 laser energy is currently used widely for the treatment of postmenopausal women who have vaginal atrophy due to the lack of estrogen. However, its effect on premenopausal women with hormonally-mediated vulvar vestibulodynia is unknown. This study seeks to evaluate the effect of CO2 laser on young women and compare it to topical lidocaine.

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Detailed Description

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The purpose of this study is to see if vaginal laser therapy with MonaLisa Touch® will be more effective in treating vestibulodynia than current treatment with a topical lidocaine ointment. Vestibulodynia is a common bothersome condition and is more likely to occur in women on hormonal contraceptive treatment. To date, there are no effective treatments that address the underlying causes of the disease. MonaLisa Touch® is a laser procedure that delivers CO2 laser energy to the vaginal wall tissue. This energy causes the patient's own body to regenerate collagen and blood vessels, changing the tissue to make it healthier. The MonaLisa Touch® technology may help vestibulodynia by potentially fixing the underlying cause. This may be more effective than using the topical lidocaine which makes the tissue numb.

Conditions

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Vulvodynia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CO2 laser

Mona Lisa CO2 laser will be applied externally to the vulvar vestibule in three sessions over a three month period.

Group Type EXPERIMENTAL

CO2 laser

Intervention Type DEVICE

Mona Lisa CO2 laser

Lidocaine

5% topical lidocaine will be applied nightly via a cotton square in participants

Group Type ACTIVE_COMPARATOR

Lidocaine patch 5%

Intervention Type DRUG

lidocaine

Interventions

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CO2 laser

Mona Lisa CO2 laser

Intervention Type DEVICE

Lidocaine patch 5%

lidocaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18 years to 40 years
* Hormonal contraceptive therapy for at least one year consecutive duration
* Vestibulodynia diagnosis meeting the following criteria:

* Localized vulvar pain to vaginal vestibule
* At least 3 months duration
* Without clear identifiable cause

Exclusion Criteria

* Suspected primary cause to vestibular pain that warrants directed treatment
* History of chronic infection or autoimmune disease
* Prior pelvic surgery including mesh placement for incontinence or prolapse, vestibulectomy, vulvectomy, or labiaplasty
* Active vulvar or vaginal infection
* Allergy or contraindication to topical lidocaine treatment
* Prior diagnosis or treatment of vulvar intraepithelial neoplasia or vulvar malignancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes