Vulvodynia
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICECO2 laser
Mona Lisa CO2 laser
lidocaine
Sponsors
Foundation for Morristown Medical Center
Atlantic Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS | 3 months | visual analog pain scale to q-tip palpation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFDI | 3 months | pelvic floor distress inventory |
Countries
United States
Outcome results
None listed