CO2 Laser vs Lidocaine for Vestibulodynia in Premenopausal Women

Vulvodynia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05336825
• Other study ID #: GSU-MLT001
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: April 2022
• Source: Atlantic Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Vulvar Vestibulitis
• Vulvodynia

Intervention

Device:
• CO2 laser
Mona Lisa CO2 laser

Drug:
• Lidocaine patch 5%
lidocaine

Locations

Country	Name	City	State
United States	Garden State Urology	Denville	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Atlantic Health System	Foundation for Morristown Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS	visual analog pain scale to q-tip palpation	3 months
Secondary	PFDI	pelvic floor distress inventory	3 months