Clinical trial NCT04737616: Continuous Monitoring and Management of Vaginal Health Via Multifunctional OCT/OCTA/OCE Endoscopy
Official title: Continuous Monitoring and Management of Vaginal Health Via Multifunctional 1.7um Optical Coherence Tomography/angiography Endoscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Genitourinary Syndrome of Menopause
Keywords: OCT: Optical coherence tomography
CO2: Carbon dioxide
GSM: genitourinary syndrome of menopause
OCE: Optical coherence angiography
OCTA:Optical coherence tomography with angiography
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2021-02-04
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Vaginal epithelial thickness (VET)
timeFrame: 2 years
Secondary outcomes:
measure: blood vessel density
timeFrame: 2 years
measure: Vaginal Health Index (VHI)
timeFrame: 2 years
measure: Lactobacillus abundance
timeFrame: 2 years
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute and Medical Clinic
state: California
Study officials:
affiliation: UC Irvine
name: Felicia Lane, MD
role: PRINCIPAL_INVESTIGATOR
References: