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CO2 Laser vs Lidocaine for Vestibulodynia in Premenopausal Women

Primary Purpose

Vulvodynia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CO2 laser
Lidocaine patch 5%
Sponsored by
Atlantic Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvodynia

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Garden State Urology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CO2 laser

Lidocaine

Arm Description

Mona Lisa CO2 laser will be applied externally to the vulvar vestibule in three sessions over a three month period.

5% topical lidocaine will be applied nightly via a cotton square in participants

Outcomes

Primary Outcome Measures

VAS
visual analog pain scale to q-tip palpation

Secondary Outcome Measures

PFDI
pelvic floor distress inventory

Full Information

First Posted
April 13, 2022
Last Updated
April 13, 2022
Sponsor
Atlantic Health System
Collaborators
Foundation for Morristown Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05336825
Brief Title
CO2 Laser vs Lidocaine for Vestibulodynia in Premenopausal Women
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Atlantic Health System
Collaborators
Foundation for Morristown Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvodynia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CO2 laser
Arm Type
Experimental
Arm Description
Mona Lisa CO2 laser will be applied externally to the vulvar vestibule in three sessions over a three month period.
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
5% topical lidocaine will be applied nightly via a cotton square in participants
Intervention Type
Device
Intervention Name(s)
CO2 laser
Intervention Description
Mona Lisa CO2 laser
Intervention Type
Drug
Intervention Name(s)
Lidocaine patch 5%
Intervention Description
lidocaine
Primary Outcome Measure Information:
Title
VAS
Description
visual analog pain scale to q-tip palpation
Time Frame
3 months
Secondary Outcome Measure Information:
Title
PFDI
Description
pelvic floor distress inventory
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Garden State Urology
City
Denville
State/Province
New Jersey
ZIP/Postal Code
07834
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CO2 Laser vs Lidocaine for Vestibulodynia in Premenopausal Women

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