CO2 Laser vs Lidocaine for Vestibulodynia in Premenopausal Women

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

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.

Study Overview

• Status: Completed
• Conditions: Vulvodynia
• Intervention / Treatment: Device: CO2 laser; Drug: Lidocaine patch 5%

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Denville, New Jersey, United States, 07834
      • Garden State Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CO2 laser; Mona Lisa CO2 laser will be applied externally to the vulvar vestibule in three sessions over a three month period.	Device: CO2 laser; Mona Lisa CO2 laser
ACTIVE_COMPARATOR: Lidocaine; 5% topical lidocaine will be applied nightly via a cotton square in participants	Drug: Lidocaine patch 5%; lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS	visual analog pain scale to q-tip palpation	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFDI	pelvic floor distress inventory	3 months

Collaborators and Investigators

• Sponsor: Atlantic Health System
• Collaborators: Foundation for Morristown Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ACTUAL): January 31, 2021
• Study Completion (ACTUAL): January 31, 2021

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (ACTUAL): April 20, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vulvar Diseases; Vulvitis; Vulvodynia; Vulvar Vestibulitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: GSU-MLT001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No