Status:
COMPLETED
CO2 Laser vs Lidocaine for Vestibulodynia in Premenopausal Women
Lead Sponsor:
Atlantic Health System
Collaborating Sponsors:
Foundation for Morristown Medical Center
Conditions:
Vulvodynia
Eligibility:
FEMALE
18-40 years
Phase:
NA
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-med...
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. Vestibulod...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05336825
Start Date
April 1 2019
End Date
January 31 2021
Last Update
April 20 2022
Active Locations (1)
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1
Garden State Urology
Denville, New Jersey, United States, 07834