Vaginal Changes After CO2 Laser (OCTRCT)

February 16, 2026 updated by: Felicia Lane, University of California, Irvine

Continuous Monitoring and Management of Vaginal Health Via Multifunctional OCT/OCTA/OCE Endoscopy, a Randomized Controlled Trial

Genitourinary syndrome of menopause (GSM) occurs due to a decline in estrogen levels as a woman approaches menopause. The syndrome negatively impacts women's quality of life and is characterized by vaginal dryness, burning, diminished lubrication, painful intercourse and urinary symptoms such as frequency and urgency. GSM is diagnosed by symptom assessment and physical exam, with current mainstay of treatment being vaginal estrogen. Women with a history of breast cancer, gynecologic cancer, or venous thromboembolism may not be candidates for hormonal therapy. Thus, there has been a quest for effective non-hormonal forms of treatment for GSM. The use of vaginal CO2 laser treatment for GSM has shown promising results.

In this study, we aim to use long-wavelength optical coherence tomography/angiography/elastography (OCT/OCTA/OCE) to document changes that occur in the vaginal epithelium during menopause as well as after treatment for GSM. OCT is a well-studied technology and is widely used in Dermatology and Ophthalmology. In collaboration with the Beckman Laser Institute (BLI), we have developed a non-invasive vaginal probe (HS# 2017-3686). The probe has subsequently been used in previous studies to validate measurements in the vaginal epithelium (HS# 2019-5446). A previous RCT compared clinical response to laser therapy to a control group that received a low level of laser therapy. The study also did not examine histology. This will be a randomized controlled trial in which women will be enrolled into one group receiving laser therapy and compared to a true sham group that will not receive laser therapy at all. Response will be measured primarily by OCT device as well as optional vaginal biopsies. There will also be questionnaires and exam of the vaginal tissue using the VHI.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Genitourinary Syndrome of Menopause (GSM) is a broad term that describes symptoms that arise from a physiologic decline in estrogen levels. Although GSM is not a life-threatening condition, it has a negative impact on a woman's quality of life with regards to general health and sexual function. Considering the years after menopause can make up the longest portion of a woman's life, safe and effective therapies to relieve the progressive menopausal symptoms over a long period are needed. Hormone therapy is commonly used to supplement the body's natural estrogen and relieve menopause symptoms. However, safety concerns associated with long-term hormone therapy exists, including the increased risk of blood clots, breast cancer, and endometrial cancer. An alternative treatment approach has been recently proposed for the relief of menopausal symptoms based on an energy-based device. While laser therapy, like CO2 micro-ablation, has demonstrated clear benefits in dermatology, it is a new application in female pelvic medicine with limited long-term follow-up.

For benign conditions such as GSM, an invasive biopsy is not indicated and not standard of care. But without histologic information, the complete pathophysiology of GSM and how alternative treatment options such as fractional-CO2 laser therapy may work, remain poorly understood. Thus, a non-invasive tool that can obtain tissue histopathological information before and over the time course of treatment is lacking in the field of pelvic medicine. We have already developed and optimized a vaginal OCT/OCTA/OCE imaging system (HS# 2017-3686) that can be used in women [9]. This technology is able to obtain a comprehensive image of the vaginal epithelium, blood vessels, and lamina propria using 1.7 μm or 1.3 μm OCT, OCTA, and OCE. In the HS# 2019-5446 IRB study, we measured the the VET (vaginal epithelium thickness) and BVD (blood vessel density) changes in four vaginal locations: distal anterior and posterior and proximal anterior and posterior at each visit using the OCT device. We saw improvement in the in the mean difference in the VET and BVD at each visit compared to the baseline measurements at visit 1. These measurements reached statistical significance by visit 4.

The focus of this study is to compare vaginal laser therapy to a sham group using the objective measurements the OCT device can provide. We expect the vaginal epithelium thickness and blood vessel density to be statistically significantly improved by the fourth follow-up visit after three laser treatments.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92612
        • Recruiting
        • Beckman Laser Institute
        • Principal Investigator:
          • Felicia Lane, MD
        • Contact:
        • Sub-Investigator:
          • Karla Lorente, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Birth sex: female
  2. Desire for vaginal laser therapy for GSM
  3. Age >=18 years old
  4. Willingness to forego other treatments for GSM within the study period
  5. Diagnosed as postmenopausal (either by surgical removal of ovaries or natural progression defined as no periods in 1 year)

Exclusion Criteria:

  1. History of pelvic radiation
  2. On hormone replacement therapy in the prior 3 months
  3. Not able or willing to follow study instructions
  4. Current diagnosis of recurrent UTIs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CO2 Vaginal Laser treatment
Laser treatment with a Fractional/Pixel CO2 laser (Femilift, Alma Lasers) will be performed with the following settings and procedure: single pulse; first pass 50-100 millijoules/pixel of energy, and 50-100 millijoules/pixel for the second pass. The energy level will be adjusted within the range based on the subject's comfort level. The same procedures will be followed for the sham group but no pulse will be generated.
Diagnostic test: Optical coherence tomography (OCT)
The OCT device with cover will be used to take measurements at four areas in the vaginal canal: the proximal posterior aspect, proximal anterior, distal anterior, and distal posterior. The proximal and distal points will be marked on the OCT cover during the first set of measurements. Markings will be used to guide measurements during subsequent visits.
Sham Comparator: Sham - no vaginal laser treatment
The vaginal laser probe will be placed as usual but no energy will be delivered to the tissue.
Diagnostic test: Optical coherence tomography (OCT)
The OCT device with cover will be used to take measurements at four areas in the vaginal canal: the proximal posterior aspect, proximal anterior, distal anterior, and distal posterior. The proximal and distal points will be marked on the OCT cover during the first set of measurements. Markings will be used to guide measurements during subsequent visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal epithelial thickness
Time Frame: Measurements will be obtained once a month for the first three months. Measurements will be obtained at subsequent follow up visits every 3 months for 1 year.
OCT measurement of vaginal epithelial thickness
Measurements will be obtained once a month for the first three months. Measurements will be obtained at subsequent follow up visits every 3 months for 1 year.
Blood vessel density
Time Frame: Measurements will be obtained once a month for the first three months. Measurements will be obtained at follow up visits every 3 months for 1 year.
OCT measurement of blood vessel density
Measurements will be obtained once a month for the first three months. Measurements will be obtained at follow up visits every 3 months for 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vulvovaginal symptoms questionnaire (VSQ)
Time Frame: Questionnaire will be obtained at baseline, during each treatment visit (once a month) and each follow up visit (every 3 months for 1 year).
Validated questionnaire to assess genitourinary syndrome of menopause symptom severity in postmenopausal patients. The score is from 0-20. Higher scores indicate worse symptoms.
Questionnaire will be obtained at baseline, during each treatment visit (once a month) and each follow up visit (every 3 months for 1 year).
Vaginal health index (VHI)
Time Frame: Physical exam will be performed at baseline, during each treatment visit (once a month) and each follow up visit (every 3 months for 1 year).
Scoring system based on provider physical exam assessing optimization of vaginal health. Scores are from 5-25, higher scores indicate better vaginal health.
Physical exam will be performed at baseline, during each treatment visit (once a month) and each follow up visit (every 3 months for 1 year).
Vaginal Microbiome
Time Frame: A vaginal swab will be obtained at baseline, during each treatment visit (once a month) and each follow up visit (every 3 months for 1 year).
Vaginal swab
A vaginal swab will be obtained at baseline, during each treatment visit (once a month) and each follow up visit (every 3 months for 1 year).
Patient Global Impression
Time Frame: Questionnaire will be completed starting the second treatment visit (once a month) and each follow up visit (every 3 months for 1 year).
Single item questionnaire assessing subjective improvement on a likert scale.
Questionnaire will be completed starting the second treatment visit (once a month) and each follow up visit (every 3 months for 1 year).
Assessment of Quality of Life 6D
Time Frame: Measurements will be obtained once a month for the first three months. Measurements will be obtained at subsequent follow up visits every 3 months for 1 year.
Validated questionnaire assessing quality of life. The scores range from 20 - 99 points.
Measurements will be obtained once a month for the first three months. Measurements will be obtained at subsequent follow up visits every 3 months for 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Alma Lasers

Investigators

  • Principal Investigator: Felicia Lane, MD, University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

September 4, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Actual)

November 15, 2024

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2080
  • 1R01EB030558-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared with anyone outside of the study group

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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