CO2 Laser vs Lidocaine for Vestibulodynia in Premenopausal Women

Atlantic Health System10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vulvodynia

Interventions

CO2 laserDEVICE

Mona Lisa CO2 laser

Lidocaine patch 5%DRUG

lidocaine

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Garden State Urology

Denville, New Jersey, United States

Outcomes

Primary Outcomes

VAS

visual analog pain scale to q-tip palpation

Time frame: 3 months

Secondary Outcomes

PFDI

pelvic floor distress inventory

Time frame: 3 months

Data from ClinicalTrials.gov

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