CO2 Laser Treatment for Genitourinary Syndrome

(OCTRCT Trial)

Overseen By Nicole Wakida

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, Irvine

Must not be taking: Hormone therapy

Disqualifiers: Pelvic radiation, Recurrent UTIs, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 3 months

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to stop other treatments for genitourinary syndrome of menopause (GSM) during the study period. If you are on hormone replacement therapy, you must have stopped it at least 3 months before joining the trial.

What data supports the effectiveness of the CO2 Laser Treatment for Genitourinary Syndrome?

Research shows that fractional CO2 laser therapy can help improve symptoms of genitourinary syndrome of menopause, which includes issues like vaginal dryness and discomfort. Studies have found it to be effective and safe for women, including breast cancer survivors, with benefits lasting up to a year after treatment. ^{1 2 3 4 5}

Is CO2 laser treatment safe for genitourinary syndrome?

Research shows that fractional CO2 laser treatment is generally safe for genitourinary syndrome of menopause, with studies reporting improvements in symptoms and only minor side effects like pain and itching. ^{1 2 5 6 7}

How is CO2 laser treatment different from other treatments for genitourinary syndrome?

CO2 laser treatment is unique because it uses a laser to deliver energy to the vaginal tissue, promoting collagen production and tissue regeneration, which is different from traditional hormone-based therapies. This non-invasive approach is particularly beneficial for individuals who cannot use hormone treatments, such as breast cancer survivors. ^{1 2 4 5 6}

What is the purpose of this trial?

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.

Research Team

Felicia Lane, MD

Principal Investigator

University of California, Irvine

Eligibility Criteria

This trial is for women experiencing genitourinary syndrome of menopause, which includes symptoms like vaginal dryness and painful intercourse. It's especially aimed at those who can't use hormonal therapy due to a history of certain cancers or blood clots. Participants should be willing to undergo laser treatment and assessments using OCT technology.

Inclusion Criteria

I am willing to not seek other treatments for my condition during the study.

I want to try vaginal laser therapy for my GSM.

I was born female.

Exclusion Criteria

I am unable or unwilling to follow the study's instructions.

I have had radiation therapy to my pelvic area.

I currently have recurring urinary tract infections.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CO2 vaginal laser treatment or sham treatment once a month for three months

3 months

3 visits (in-person)

Follow-up

Participants are monitored for changes in vaginal epithelial thickness and blood vessel density, as well as symptom severity and quality of life

12 months

4 visits (in-person) every 3 months

Treatment Details

Interventions

• CO2 Laser

Trial Overview The study tests the effectiveness of CO2 laser therapy on improving symptoms of GSM by comparing two groups: one receiving actual laser treatment and another receiving sham (fake) treatment. Changes in the vaginal tissue will be monitored with an OCT device, biopsies, questionnaires, and physical exams.

Participant Groups

Group I: CO2 Vaginal Laser treatment Experimental Treatment 1 Intervention

Laser treatment with a Fractional/Pixel CO2 laser (Femilift, Alma Lasers) will be performed with the following settings and procedure: single pulse; first pass 50-100 millijoules/pixel of energy, and 50-100 millijoules/pixel for the second pass. The energy level will be adjusted within the range based on the subject's comfort level. The same procedures will be followed for the sham group but no pulse will be generated.

Group II: Sham - no vaginal laser treatment Placebo Group 1 Intervention

The vaginal laser probe will be placed as usual but no energy will be delivered to the tissue.

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

Approved in United States as CO2 Laser for:

• Scleroderma-induced microstomia
• Various skin conditions

Approved in European Union as CO2 Laser for:

• Scleroderma-induced microstomia
• Various skin conditions

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

Alma Lasers

Industry Sponsor

Trials

10

Recruited

220+

Findings from Research

The micro-fractional CO2 laser treatment significantly improved sexual function and quality of life in both menopausal and non-menopausal women suffering from vulvovaginal atrophy, as measured by the Female Sexual Function Index (FSFI) and quality of life scores at 3 and 6 months post-treatment.

The study involved 50 symptomatic patients (25 menopausal and 25 non-menopausal) who received two laser sessions, and importantly, there were no significant adverse events reported, indicating the treatment's safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The results of new low dose fractional CO2 Laser - A prospective clinical study in France. Marin, J., Lipa, G., Dunet, E.[2021]

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 53 postmenopausal women, three sessions of Microablative Fractional CO2 Laser therapy significantly improved vaginal health, as indicated by increased Vaginal Maturation Value (VMV) and Vaginal Health Index Score (VHIS).

The therapy also led to a notable reduction in symptoms associated with the Genitourinary Syndrome of Menopause (GSM), including dryness, pain during intercourse (dyspareunia), and urinary issues, suggesting it is an effective treatment option for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microablative fractional CO2-laser therapy and the genitourinary syndrome of menopause: An observational study. Pitsouni, E., Grigoriadis, T., Tsiveleka, A., et al.[2022]

The fractionated CO2 laser is increasingly used by healthcare providers to treat gynecologic issues like genitourinary syndrome of menopause (GSM), but there is limited data on its effectiveness and safety.

Current guidance on the use of this treatment is challenging due to the lack of comprehensive studies, highlighting the need for more research to establish clear recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vulvar and vaginal fractional CO2 laser treatments for genitourinary syndrome of menopause. Streicher, LF.[2019]

Fractional CO2 laser therapy significantly improved symptoms of genitourinary syndrome of menopause (GSM) in 30 women over a 1-year follow-up, with persistent benefits in pain, burning, itching, dryness, and dyspareunia, while maintaining safety with no adverse events leading to treatment withdrawal.

A high satisfaction rate was reported, with 92% of women expressing satisfaction with the treatment at 1 year, indicating that fractional CO2 laser therapy is both effective and well-tolerated for managing GSM symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a novel fractional CO2 laser for the treatment of genitourinary syndrome of menopause: 1-year outcomes. Sokol, ER., Karram, MM.[2019]

The study involving 30 women with genitourinary syndrome of menopause (GSM) demonstrated that the novel fractional CO2 laser treatment is both safe and effective, with no participants withdrawing due to adverse events.

Significant improvements were observed in symptoms such as vaginal dryness and dyspareunia, with 83% of participants increasing their comfortable dilator size and 96% reporting satisfaction with the treatment after three sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An assessment of the safety and efficacy of a fractional CO2 laser system for the treatment of vulvovaginal atrophy. Sokol, ER., Karram, MM.[2018]

In a clinical trial involving 47 women aged 43-80, fractional CO2 laser treatment significantly improved symptoms of vulvovaginal atrophy, including vaginal dryness, dyspareunia, and itching, with a p-value of less than 0.001 indicating strong efficacy.

The treatment was found to be safe, with adverse effects like pain and itching monitored throughout the study, suggesting that fractional CO2 laser could be a viable option for managing genitourinary syndrome of menopause (GSM).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional CO2 Laser for Treatment of Vulvovaginal Atrophy: A Short Time Follow-up. Ghanbari, Z., Sohbati, S., Eftekhar, T., et al.[2021]

References

1. France pubmed.ncbi.nlm.nih.gov

The results of new low dose fractional CO2 Laser - A prospective clinical study in France. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

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

3. Ireland pubmed.ncbi.nlm.nih.gov

Microablative fractional CO2-laser therapy and the genitourinary syndrome of menopause: An observational study. [2022]

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

Vulvar and vaginal fractional CO2 laser treatments for genitourinary syndrome of menopause. [2019]

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

Use of a novel fractional CO2 laser for the treatment of genitourinary syndrome of menopause: 1-year outcomes. [2019]

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

An assessment of the safety and efficacy of a fractional CO2 laser system for the treatment of vulvovaginal atrophy. [2018]

7. Iran pubmed.ncbi.nlm.nih.gov

Fractional CO2 Laser for Treatment of Vulvovaginal Atrophy: A Short Time Follow-up. [2021]