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

Genitourinary Syndrome of Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04737616
• Other study ID #: HS# 2019-5446
• Status: Recruiting
• Phase: N/A
• Start date: July 16, 2020
• Est. completion date: July 1, 2024

Study information

• Verified date: July 2023
• Source: University of California, Irvine
• Contact: Linh Huynh, MPH
• Phone: 714- 456-6155
• Email: plhuynh[@]hs.uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Genitourinary Syndrome of Menopause

Intervention

Device:
• CO2 laser
Fractional CO2 vaginal laser for genitourinary syndrome of menopause
• OCT
Optical coherence tomography endoscope

Locations

Country	Name	City	State
United States	UC Irvine	Costa Mesa	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal epithelial thickness (VET)	Vaginal epithelium thickness measured with the OCT.	2 years
Secondary	blood vessel density	The blood vessel density will be measured by OCT	2 years
Secondary	Vaginal Health Index (VHI)	VHI to be measured on exam	2 years
Secondary	Lactobacillus abundance	Lactobacillus abundance by RNA sequencing	2 years