Vaginal Changes After CO2 Laser

NCT ID: NCT06691178

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2027-07-01

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.

Conditions

Genitourinary Syndrome of Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Optical coherence tomography (OCT)

Intervention Type: DIAGNOSTIC_TEST

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 - no vaginal laser treatment

The vaginal laser probe will be placed as usual but no energy will be delivered to the tissue.

Group Type: SHAM_COMPARATOR

Optical coherence tomography (OCT)

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Alma Lasers

INDUSTRY

Sponsor Role: collaborator

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Felicia Lane

Division Director of Urogynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felicia Lane, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

Beckman Laser Institute

Irvine, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Karla LORENTE, MD

Role: CONTACT

klorente@hs.uci.edu

714-798-9044

Nicole Wakida

Role: CONTACT

nwakida@hs.uci.edu

949.824.3295

Facility Contacts

Nicole Wakida

Role: primary

nwakida@uci.edu

949.824.3295

Felicia Lane, MD

Role: backup

Karla Lorente, MD

Role: backup

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

1R01EB030558-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2080

Identifier Type: -

Identifier Source: org_study_id