OCT Imaging + CO2 Laser Therapy for Genitourinary Syndrome

Recruiting at 1 trial location

Overseen By Linh Huynh, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, Irvine

Must not be taking: Hormone therapy

Disqualifiers: Pelvic irradiation, Pregnant, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

90 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used hormone replacement therapy within three months before joining the study.

What data supports the effectiveness of this treatment for genitourinary syndrome?

Research shows that fractional CO2 laser therapy can increase vaginal tissue thickness in some postmenopausal women, which may help alleviate symptoms of genitourinary syndrome. Additionally, studies suggest that this laser treatment could be as effective as topical estrogen therapy for managing these symptoms. ^{1 2 3 4 5}

Is CO2 laser therapy safe for humans?

Research shows that fractional CO2 laser therapy is generally safe for treating conditions like vaginal atrophy in postmenopausal women, with no significant side effects compared to conventional treatments. Studies also indicate that the therapy is stable and effective in animal models, suggesting it is a safe option for humans. ^{3 6 7 8 9}

How is the OCT Imaging + CO2 Laser Therapy treatment for genitourinary syndrome different from other treatments?

This treatment is unique because it combines CO2 laser therapy, which helps rejuvenate vaginal tissue, with OCT imaging, a noninvasive technique that allows doctors to see detailed images of the tissue structure. This combination can help tailor the treatment to each person by monitoring changes in tissue thickness, potentially improving effectiveness. ^{1 3 5 7 10}

Research Team

Felicia Lane, MD

Principal Investigator

UC Irvine

Eligibility Criteria

This trial is for premenopausal, peri-menopausal, and postmenopausal women to study vaginal health. For the second part of the study, only postmenopausal women with genitourinary syndrome can join. Women who've had pelvic radiation, are pregnant or breastfeeding, recently used hormone therapy, or can't follow instructions in English are excluded.

Inclusion Criteria

I am a postmenopausal woman experiencing vaginal dryness, itching, or pain.

I am a woman who has not gone through menopause.

Exclusion Criteria

I have had radiation treatment to my pelvic area.

I have not used hormone replacement therapy in the last three months.

I can follow all research instructions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

OCT Imaging

Participants undergo an OCT scan of the vaginal tissue to assess vaginal health

1 visit

1 visit (in-person)

CO2 Laser Treatment

Postmenopausal women receive CO2 vaginal laser treatment over three visits

3 visits

3 visits (in-person)

Follow-up

Participants are monitored for long-term effects of the laser treatment with repeat OCT imaging

12 months

4 visits (in-person) at 3, 6, 9, and 12 months

Treatment Details

Interventions

• CO2 laser
• OCT

Trial Overview The trial is testing a new imaging system called Optical Coherence Tomography (OCT) endoscopy on vaginal tissues. It aims to detect changes due to menopause and observe how fractional-CO2 laser treatment affects these tissues over time.

Participant Groups

Group I: OCT only Experimental Treatment 1 Intervention

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

Group II: CO2 Laser +OCT Experimental Treatment 2 Interventions

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

CO2 laser is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Fractional-CO2 laser therapy for:

• Genitourinary syndrome of menopause (GSM)
• Vaginal rejuvenation
• Vaginal dryness

Approved in European Union as CO2 vaginal laser therapy for:

• Vaginal atrophy
• Vaginal dryness
• Genitourinary syndrome of menopause (GSM)

Approved in Canada as Fractional-CO2 laser therapy for:

• Vaginal rejuvenation
• Vaginal dryness
• Genitourinary syndrome of menopause (GSM)

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

A pilot study involving 12 postmenopausal women showed that fractional-pixel CO2 laser treatment can increase vaginal epithelial thickness (VET) in some patients, indicating potential efficacy for treating genitourinary syndrome of menopause (GSM).

The study utilized intravaginal optical coherence tomography (OCT) to monitor changes in VET, suggesting that this imaging technique could help personalize laser treatments based on individual tissue characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical coherence tomography evaluation of vaginal epithelial thickness during CO2 laser treatment: A pilot study. Miao, Y., Sudol, NT., Li, Y., et al.[2023]

In a study of 205 perimenopausal women, CO₂ fractional laser therapy significantly improved symptoms like vaginal dryness, painful intercourse, and urinary incontinence, with benefits lasting up to 12 months after three treatment sessions.

The therapy was found to be safe, with no complications reported during or after the treatment, indicating a favorable safety profile for managing urogenital symptoms in perimenopausal women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The CO2 ablative laser treatment in perimenopausal patients with vulvovaginal atrophy. Rosner-Tenerowicz, A., Zimmer-Stelmach, A., Zimmer, M.[2021]

Optical coherence tomography (OCT) effectively visualizes vaginal tissue microstructure, showing that vaginal epithelial thickness decreases significantly with menopause, indicating potential changes in vaginal health as women age.

After treatment with fractional-pixel CO2 laser therapy, some women experienced significant increases in epithelial thickness, correlating with reported improvements in vaginal symptoms, suggesting that this treatment may be beneficial for menopausal women with genitourinary syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical Vaginal Biopsy Using Optical Coherence Tomography. Sudol, NT., Miao, Y., Li, Y., et al.[2022]

In a randomized controlled trial of 25 postmenopausal women, both fractional CO2 laser therapy and topical estrogen therapy significantly increased vaginal epithelium thickness, indicating effective treatment for vulvovaginal atrophy.

While both treatments improved sexual function and reduced atrophy, topical estrogen therapy showed a higher maturation index, suggesting it may be slightly more effective in certain aspects compared to laser therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of topical fractional CO2 laser and vaginal estrogen for the treatment of genitourinary syndrome in postmenopausal women: a randomized controlled trial. Dutra, PFSP., Heinke, T., Pinho, SC., et al.[2023]

Laser treatments, specifically fractional CO2 and vaginal erbium lasers, may significantly alleviate symptoms of genitourinary syndrome of menopause (GSM) in breast cancer survivors, with improvements in sexual function and vaginal health lasting up to 12 months based on six observational studies.

The safety profile of these laser treatments is promising, as no adverse effects were reported, and only a few patients discontinued treatment due to discomfort, indicating a good tolerability among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser treatment for the management of genitourinary syndrome of menopause after breast cancer. Hope or hype? Tranoulis, A., Georgiou, D., Michala, L.[2021]

The novel fractional CO2 laser developed for treating cervical diseases demonstrated greater depth of penetration and more consistent laser spot size compared to a conventional CO2 laser, indicating improved efficacy.

Both the novel and conventional CO2 lasers showed similar side effects, suggesting that the new apparatus is as safe as the traditional method while offering enhanced performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of the efficiency and stability of a novel visualized lattice CO2 laser-based gynecological therapeutic apparatus for the treatment of cervical diseases in rhesus monkeys. Chen, F., Gan, Y., Wang, HW.[2022]

In a study involving 64 breast cancer survivors, fractional CO2 laser therapy was found to be feasible, with 88.1% of participants completing all treatments without any serious adverse events.

The therapy significantly improved symptoms of genitourinary syndrome of menopause, as evidenced by reductions in scores on the Vaginal Assessment Scale, Female Sexual Function Index, and Urinary Distress Index, all with p-values less than 0.001.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional CO2 laser therapy for genitourinary syndrome of menopause for breast cancer survivors. Quick, AM., Zvinovski, F., Hudson, C., et al.[2020]

In a study of 373 CO₂ laser treatments on 287 patients, adverse events (AEs) occurred in 12.6% of treatments, with the most common being allergic dermatitis (4.6%) and acneiform breakouts (3.5%).

The risk of AEs increased significantly when multiple body areas were treated simultaneously, with 37.5% of patients experiencing AEs when three areas were treated, while subsequent treatments on the same area after healing showed no increased risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of fractionated carbon dioxide laser: review of 373 treatments. Campbell, TM., Goldman, MP.[2012]

Fractional CO2 laser treatment for vulvo-vaginal atrophy in postmenopausal women is considered safe, with no severe complications reported in a study of 53 participants over a median follow-up of six months.

Patient satisfaction was high, with 89.7% of participants willing to recommend the procedure and 94.9% ready to repeat it, despite some mild discomfort mainly associated with probe introduction and rotation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety evaluation of fractional CO2 laser treatment in post-menopausal women with vaginal atrophy: A prospective observational study. Di Donato, V., D'Oria, O., Scudo, M., et al.[2020]

Optical coherence tomography (OCT) can effectively differentiate between normal and pathological gynecological tissues during laparoscopic procedures by analyzing tissue architecture, which could lead to earlier and more effective interventions.

This high-resolution imaging technology allows for real-time subsurface imaging, enhancing conventional laparoscopy and potentially improving diagnostic accuracy near the level of histopathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High resolution imaging of endometriosis and ovarian carcinoma with optical coherence tomography: feasibility for laparoscopic-based imaging. Boppart, SA., Goodman, A., Libus, J., et al.[2019]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Optical coherence tomography evaluation of vaginal epithelial thickness during CO2 laser treatment: A pilot study. [2023]

2. Poland pubmed.ncbi.nlm.nih.gov

The CO2 ablative laser treatment in perimenopausal patients with vulvovaginal atrophy. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Optical Vaginal Biopsy Using Optical Coherence Tomography. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of topical fractional CO2 laser and vaginal estrogen for the treatment of genitourinary syndrome in postmenopausal women: a randomized controlled trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Laser treatment for the management of genitourinary syndrome of menopause after breast cancer. Hope or hype? [2021]

6. England pubmed.ncbi.nlm.nih.gov

Investigation of the efficiency and stability of a novel visualized lattice CO2 laser-based gynecological therapeutic apparatus for the treatment of cervical diseases in rhesus monkeys. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Fractional CO2 laser therapy for genitourinary syndrome of menopause for breast cancer survivors. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse events of fractionated carbon dioxide laser: review of 373 treatments. [2012]

9. Ireland pubmed.ncbi.nlm.nih.gov

Safety evaluation of fractional CO2 laser treatment in post-menopausal women with vaginal atrophy: A prospective observational study. [2020]

10. England pubmed.ncbi.nlm.nih.gov

High resolution imaging of endometriosis and ovarian carcinoma with optical coherence tomography: feasibility for laparoscopic-based imaging. [2019]