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
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2021
CompletedFirst Submitted
Initial submission to the registry
April 13, 2022
CompletedFirst Posted
Study publicly available on registry
April 20, 2022
CompletedApril 20, 2022
April 1, 2022
1.8 years
April 13, 2022
April 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
VAS
visual analog pain scale to q-tip palpation
3 months
Secondary Outcomes (1)
PFDI
3 months
Study Arms (2)
CO2 laser
EXPERIMENTALMona Lisa CO2 laser will be applied externally to the vulvar vestibule in three sessions over a three month period.
Lidocaine
ACTIVE COMPARATOR5% topical lidocaine will be applied nightly via a cotton square in participants
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Atlantic Health Systemlead
- Foundation for Morristown Medical Centercollaborator
Study Sites (1)
Garden State Urology
Denville, New Jersey, 07834, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of The Center for Specialized Women's Health, division of Garden State Urology/Atlantic Health System
Study Record Dates
First Submitted
April 13, 2022
First Posted
April 20, 2022
Study Start
April 1, 2019
Primary Completion
January 31, 2021
Study Completion
January 31, 2021
Last Updated
April 20, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share