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

Not Applicable

Recruiting

• Conditions: Genitourinary Syndrome of Menopause
• Interventions: Device: OCT; Device: CO2 laser

• Registration Number: NCT04737616
• Lead Sponsor: University of California, Irvine

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.

Study Timeline

• Study Start: 2020-07-16
• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-04
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OCT only	OCT	Premenopausal, peri-menopausal and postmenopausal women who will only get one time OCT scan
CO2 Laser +OCT	OCT	Postmenopausal women with genitourinary syndrome of menopause who will receive CO2 vaginal laser treatment
CO2 Laser +OCT	CO2 laser	Postmenopausal women with genitourinary syndrome of menopause who will receive CO2 vaginal laser treatment

Primary Outcome Measures

Name	Time	Method
Vaginal epithelial thickness (VET)	2 years	Vaginal epithelium thickness measured with the OCT.

Secondary Outcome Measures

Name	Time	Method
Vaginal Health Index (VHI)	2 years	VHI to be measured on exam
blood vessel density	2 years	The blood vessel density will be measured by OCT
Lactobacillus abundance	2 years	Lactobacillus abundance by RNA sequencing

Trial Locations

Locations (1)

Beckman Laser Institute and Medical Clinic; 🇺🇸 Irvine, California, United States