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Completed

NCT Number: NCT05336825

CO2 Laser vs Lidocaine for Vestibulodynia in Premenopausal Women

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Garden State Urology

Denville, New Jersey, 07834, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CO2 laser

Device

Mona Lisa CO2 laser

Lidocaine patch 5%

Drug

lidocaine

Primary outcomes

  1. VAS

    Time frame: 3 months

    visual analog pain scale to q-tip palpation

Secondary outcomes

  1. PFDI

    Time frame: 3 months

    pelvic floor distress inventory

Sponsors and collaborators

Lead sponsor

Atlantic Health System

Other

Collaborators

  • Foundation for Morristown Medical Center

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 20, 2022
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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