Vaginal Changes After CO2 Laser

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Genitourinary Syndrome of Menopause

In brief

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.

Key facts

Study ID: NCT06691178
Run by: University of California, Irvine
People needed: 50
Starts: 2023-05-01
Expected to finish: 2027-07-01
Last updated by the study team: 2026-02-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Birth sex: female
Desire for vaginal laser therapy for GSM
Age >=18 years old
Willingness to forego other treatments for GSM within the study period
Diagnosed as postmenopausal (either by surgical removal of ovaries or natural progression defined as no periods in 1 year)

You may not qualify if…

History of pelvic radiation
On hormone replacement therapy in the prior 3 months
Not able or willing to follow study instructions
Current diagnosis of recurrent UTIs

Where it is running

Beckman Laser Institute — Irvine, California, United States (enrolling)

Full record on ClinicalTrials.gov

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