CO2 Laser vs Lidocaine for Vestibulodynia in Premenopausal Women

Not Applicable

Completed

• Conditions: Vulvodynia
• Interventions: Drug: Lidocaine patch 5%; Device: CO2 laser

• Registration Number: NCT05336825
• Lead Sponsor: Atlantic Health System

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.

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2022-04
• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-04-13
• Last Update Submitted: 2022-04-13
• Study First Posted: 2022-04-20
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine	Lidocaine patch 5%	5% topical lidocaine will be applied nightly via a cotton square in participants
CO2 laser	CO2 laser	Mona Lisa CO2 laser will be applied externally to the vulvar vestibule in three sessions over a three month period.

Primary Outcome Measures

Name	Time	Method
VAS	3 months	visual analog pain scale to q-tip palpation

Secondary Outcome Measures

Name	Time	Method
PFDI	3 months	pelvic floor distress inventory

Trial Locations

Locations (1)

Garden State Urology; 🇺🇸 Denville, New Jersey, United States