Clincosm LogoSign in Get a demo

CO2 Laser vs Lidocaine for Vestibulodynia in Premenopausal Women

Sponsor
Atlantic Health System (Other)
Overall Status
Completed
CT.gov ID
NCT05336825
Collaborator
Foundation for Morristown Medical Center (Other)
10
Enrollment
1
Location
2
Arms
22
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CO2 laser
  • Drug: Lidocaine patch 5%
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Jan 31, 2021
Actual Study Completion Date :
Jan 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. VAS [3 months]

    visual analog pain scale to q-tip palpation

Secondary Outcome Measures

  1. PFDI [3 months]

    pelvic floor distress inventory

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Garden State Urology Denville New Jersey United States 07834

Sponsors and Collaborators

  • Atlantic Health System
  • Foundation for Morristown Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael Ingber, Director of The Center for Specialized Women's Health, division of Garden State Urology/Atlantic Health System, Atlantic Health System
ClinicalTrials.gov Identifier:
NCT05336825
Other Study ID Numbers:
  • GSU-MLT001
First Posted:
Apr 20, 2022
Last Update Posted:
Apr 20, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Vulvodynia
Vulvar Vestibulitis
Lidocaine

Study Results

No Results Posted as of Apr 20, 2022