CO2 Laser vs Lidocaine for Vestibulodynia in Premenopausal Women

Atlantic Health System

Status: Completed

Conditions: Vulvodynia

Treatments: Drug: Lidocaine patch 5%; Device: CO2 laser

Study type: Interventional

Funder types: Other

Identifiers

NCT05336825

GSU-MLT001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

CO2 laser

Experimental group

Description:

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

Treatment:

Device: CO2 laser

Lidocaine

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine patch 5%