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

University of California Irvine (UCI)

Status: Active, not recruiting

Conditions: Genitourinary Syndrome of Menopause

Treatments: Device: CO2 laser; Device: OCT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04737616

20195446

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

CO2 Laser +OCT

Experimental group

Description:

Postmenopausal women with genitourinary syndrome of menopause who will receive CO2 vaginal laser treatment

Treatment:

Device: OCT

Device: CO2 laser

OCT only

Experimental group

Description:

Premenopausal, peri-menopausal and postmenopausal women who will only get one time OCT scan

Treatment:

Device: OCT