Clinical trial NCT06691178: Vaginal Changes After CO2 Laser
Official title: Continuous Monitoring and Management of Vaginal Health Via Multifunctional OCT/OCTA/OCE Endoscopy, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Genitourinary Syndrome of Menopause
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Alma Lasers
name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2024-11-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Vaginal epithelial thickness
timeFrame: 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.
measure: Blood vessel density
timeFrame: 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 outcomes:
measure: Vulvovaginal symptoms questionnaire (VSQ)
timeFrame: Questionnaire will be obtained at baseline, during each treatment visit (once a month) and each follow up visit (every 3 months for 1 year).
measure: Vaginal health index (VHI)
timeFrame: 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).
measure: Vaginal Microbiome
timeFrame: 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).
measure: Patient Global Impression
timeFrame: Questionnaire will be completed starting the second treatment visit (once a month) and each follow up visit (every 3 months for 1 year).
measure: Assessment of Quality of Life 6D
timeFrame: 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.
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute
state: California
Study officials:
affiliation: University of California, Irvine
name: Felicia Lane, MD
role: PRINCIPAL_INVESTIGATOR
References:
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