Overview

CO2 Laser vs Lidocaine for Vestibulodynia in Premenopausal Women

Status:
Completed
Trial end date:
2021-01-31
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Atlantic Health System
Collaborator:
Foundation for Morristown Medical Center
Treatments:
Lidocaine
Criteria
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