CO2 Laser vs Lidocaine for Vestibulodynia in Premenopausal Women

Study Overview
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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.

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.

Official Title
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The Application of External Fractional CO2 Laser Energy Versus Topical Lidocaine for the Treatment of Vestibulodynia in Premenopausal Women on Hormonal Contraception: a Pilot Study

Conditions
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Vulvodynia

Intervention / Treatment
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* Device: CO2 laser
* Drug: Lidocaine patch 5%


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CO2 laser<br>Mona Lisa CO2 laser will be applied externally to the vulvar vestibule in three sessions over a three month period. | Device: CO2 laser<br>* Mona Lisa CO2 laser<br>|
| Active Comparator: Lidocaine<br>5% topical lidocaine will be applied nightly via a cotton square in participants | Drug: Lidocaine patch 5%<br>* lidocaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS | visual analog pain scale to q-tip palpation | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFDI | pelvic floor distress inventory | 3 months |