Continuous Monitoring and Management of Vaginal Health Via Multifunctional OCT/OCTA/OCE Endoscopy, a Randomized Controlled Trial
University of California, Irvine
Summary
Genitourinary syndrome of menopause (GSM) occurs due to a decline in estrogen levels as a woman approaches menopause. The syndrome negatively impacts women's quality of life and is characterized by vaginal dryness, burning, diminished lubrication, painful intercourse and urinary symptoms such as frequency and urgency. GSM is diagnosed by symptom assessment and physical exam, with current mainstay of treatment being vaginal estrogen. Women with a history of breast cancer, gynecologic cancer, or venous thromboembolism may not be candidates for hormonal therapy. Thus, there has been a quest for effective non-hormonal forms of treatment for GSM. The use of vaginal CO2 laser treatment for GSM has shown promising results. In this study, we aim to use long-wavelength optical coherence tomography/angiography/elastography (OCT/OCTA/OCE) to document changes that occur in the vaginal epithelium during menopause as well as after treatment for GSM. OCT is a well-studied technology and is widely used in Dermatology and Ophthalmology. In collaboration with the Beckman Laser Institute (BLI), we have developed a non-invasive vaginal probe (HS# 2017-3686). The probe has subsequently been used in previous studies to validate measurements in the vaginal epithelium (HS# 2019-5446). A previous RCT compared clinical response to laser therapy to a control group that received a low level of laser therapy. The study also did not examine histology. This will be a randomized controlled trial in which women will be enrolled into one group receiving laser therapy and compared to a true sham group that will not receive laser therapy at all. Response will be measured primarily by OCT device as well as optional vaginal biopsies. There will also be questionnaires and exam of the vaginal tissue using the VHI.
Description
Genitourinary Syndrome of Menopause (GSM) is a broad term that describes symptoms that arise from a physiologic decline in estrogen levels. Although GSM is not a life-threatening condition, it has a negative impact on a woman's quality of life with regards to general health and sexual function. Considering the years after menopause can make up the longest portion of a woman's life, safe and effective therapies to relieve the progressive menopausal symptoms over a long period are needed. Hormone therapy is commonly used to supplement the body's natural estrogen and relieve menopause symptoms. H…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Birth sex: female 2. Desire for vaginal laser therapy for GSM 3. Age \>=18 years old 4. Willingness to forego other treatments for GSM within the study period 5. Diagnosed as postmenopausal (either by surgical removal of ovaries or natural progression defined as no periods in 1 year) Exclusion Criteria: 1. History of pelvic radiation 2. On hormone replacement therapy in the prior 3 months 3. Not able or willing to follow study instructions 4. Current diagnosis of recurrent UTIs
Interventions
- Diagnostic TestOptical coherence tomography (OCT)
The OCT device with cover will be used to take measurements at four areas in the vaginal canal: the proximal posterior aspect, proximal anterior, distal anterior, and distal posterior. The proximal and distal points will be marked on the OCT cover during the first set of measurements. Markings will be used to guide measurements during subsequent visits.
Location
- Beckman Laser InstituteIrvine, California