Continuous Monitoring and Management of Vaginal Health Via Multifunctional OCT/OCTA/OCE Endoscopy

Study Overview
=================
Brief Summary
-----------------
We have recently developed and optimized a vaginal Optical Coherence tomography/angiography endoscopy imaging system. This technology is able to obtain a comprehensive image of the vaginal epithelium, blood vessels, and lamina propria. The primary focus of this study is establishing the Optical Coherence Tomography system's capability of capturing vaginal changes that occur before and after menopause, as well as before and after treatment with fractional-CO2 laser therapy. There are two aims of this study. Aim 1: 1. To determine the feasibility and sensitivity of the integrated optical coherence endoscope to assess vaginal tissue integrity in pre, peri and postmenopausal women. Aim 2: To optically visualize the effects of fractional-CO2 laser treatment on vaginal tissue over the course of C02 vaginal laser therapy.

Detailed Description
-----------------
The vaginal Optical Coherence tomography/angiography endoscopy imaging system. This technology is able to obtain a comprehensive image of the vaginal epithelium, blood vessels, and lamina propria. The primary focus of this study is establishing the Optical Coherence Tomography system's capability of capturing vaginal changes that occur before and after menopause, as well as before and after treatment with fractional-CO2 laser therapy. There are two aims of this study. Aim 1: To determine the feasibility and sensitivity of the integrated optical coherence endoscope to assess vaginal tissue integrity in pre, peri and postmenopausal women We will enroll up to 90 women (age: 18 and older) who will be classified as pre-menopausal, peri- menopausal, or post-menopausal. There will be 30 women in each group. All enrolled subjects will first complete informed consents. They will then fill out a questionnaire (the vulvovaginal symptom questionnaire) about their vaginal health. This will be followed by a pelvic exam to determine the vaginal health (vaginal health index) and to obtain a vaginal swab for assessment of the vaginal microbiome . This will be followed by OCT scan of the vaginal tissue. There will be only one visit. Aim 2: To optically visualize the effects of fractional-CO2 laser treatment on vaginal tissue over the course of C02 vaginal laser therapy. Up to thirty Post-menopausal subjects with GSM who desire fractional-CO2 laser therapy, will be recruited. Each visit will include: completion of a questionnaire (the vulvovaginal symptom questionnaire) about their vaginal health; followed by a pelvic exam to determine the vaginal health (vaginal health index) and to obtain a vaginal swab for assessment of the vaginal microbiome and an OCT scan of the vaginal tissue before the CO2 vaginal laser treatment. This group will have a total of three visits with CO2 laser treatments. There will be a fourth visit which will include all the above study procedures except the CO2 laser treatment. Subjects who complete 3 laser treatments will be offered participation in long term follow up with repeat OCT imaging every 3 months at 3, 6, 9 and 12 months after the final laser treatment to study the long- term effects of the laser treatment on the vaginal tissue.

Official Title
-----------------
Continuous Monitoring and Management of Vaginal Health Via Multifunctional 1.7um Optical Coherence Tomography/Angiography Endoscopy

Conditions
-----------------
Genitourinary Syndrome of Menopause

Intervention / Treatment
-----------------
* Device: CO2 laser
* Device: OCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Aim 1: . Women who are premenopausal, peri-menopausal and postmenopausal Aim 2: . Postmenopausal women with genitourinary syndrome of menopause Exclusion criteria history of pelvic irradiation Current pregnant or breastfeeding Use of hormone replacement therapy within three months of study enrollment Inability to read and understand english inability to follow research instructions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CO2 Laser +OCT<br>Postmenopausal women with genitourinary syndrome of menopause who will receive CO2 vaginal laser treatment | Device: CO2 laser<br>* Fractional CO2 vaginal laser for genitourinary syndrome of menopause<br>Device: OCT<br>* Optical coherence tomography endoscope<br>|
| Experimental: OCT only<br>Premenopausal, peri-menopausal and postmenopausal women who will only get one time OCT scan | Device: OCT<br>* Optical coherence tomography endoscope<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal epithelial thickness (VET) | Vaginal epithelium thickness measured with the OCT. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood vessel density | The blood vessel density will be measured by OCT | 2 years | 
| Vaginal Health Index (VHI) | VHI to be measured on exam | 2 years | 
| Lactobacillus abundance | Lactobacillus abundance by RNA sequencing | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OCT: Optical coherence tomography, CO2: Carbon dioxide, GSM: genitourinary syndrome of menopause, OCE: Optical coherence angiography, OCTA:Optical coherence tomography with angiography