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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores CO2 laser treatment as a non-hormonal option for women with genitourinary syndrome of menopause (GSM). GSM can cause symptoms like vaginal dryness, burning, painful intercourse, and frequent urination, which can disrupt daily life. The trial compares the effects of laser treatment to a sham treatment (placebo), using a special imaging device to track changes in vaginal tissue. Women who are postmenopausal, seek laser therapy for GSM, and are not on hormone therapy or have a history of pelvic radiation might be suitable candidates. Participants must avoid other GSM treatments during the study. As an unphased trial, this study offers participants the chance to contribute to understanding a potential new treatment for GSM.

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 prior data suggests that this CO2 laser treatment is safe for genitourinary syndrome of menopause?

Research has shown that CO2 laser treatment is generally safe for treating genitourinary syndrome of menopause (GSM). Many studies indicate that this treatment can significantly improve symptoms like vaginal dryness and discomfort. For instance, one study found that 84% of women experienced significant improvement after the treatment.

However, some studies do not fully report safety details. Despite this, studies that do report on safety usually find few serious side effects. The treatment does not involve hormones, making it a possible option for those who cannot use hormonal therapies.

Overall, while most studies suggest CO2 laser treatment is well-tolerated, it is important to note that some safety information might be limited. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CO2 laser treatment for genitourinary syndrome because it offers a non-hormonal, non-invasive option that differs from current treatments like topical estrogen therapy. This laser treatment uses fractional CO2 technology to stimulate tissue regeneration and improve vaginal health, potentially reducing symptoms like dryness and irritation. Unlike hormonal treatments, which can have systemic effects, the CO2 laser targets the tissue directly, promoting a natural healing response without introducing hormones into the body. This unique mechanism of action could provide relief for those unable or unwilling to use estrogen-based therapies.

What evidence suggests that CO2 laser treatment might be an effective treatment for genitourinary syndrome of menopause?

This trial will compare CO2 laser treatment with a sham procedure for genitourinary syndrome of menopause (GSM). Studies have shown mixed results regarding the effectiveness of CO2 laser treatment for GSM. Some research suggests that this treatment can improve quality of life, particularly in sexual function for women with GSM symptoms. However, other studies indicate that the laser treatment is no more effective than a placebo (a treatment with no active ingredient) for GSM. Evidence suggests that laser therapy could be a cost-effective option for treating painful intercourse related to GSM. Overall, findings vary, and there is no strong consensus on its effectiveness for GSM. ^{1 3 5 6 7}

Who Is on the Research Team?

Felicia Lane, MD

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10216245/

Efficacy of Fractional CO2 Laser Treatment for ... Fractional CO 2 laser therapy increases the quality of life by having a beneficial effect on the sexual function of women with GSM symptoms.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2801236

Effect of Fractional Carbon Dioxide vs Sham Laser ... These findings suggest that although vaginal laser treatment was safe, it was not more effective than first-line therapy with placebo treatment.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002937820306402

A cost-effectiveness analysis of vaginal carbon dioxide ... This study showed that vaginal fractional CO 2 laser therapy is a cost-effective treatment strategy for dyspareunia associated with GSM.

4. spandidos-publications.com spandidos-publications.com/10.3892/etm.2023.12297

A meta‑analysis of randomized controlled trials Carbon dioxide laser therapy for the management of genitourinary syndrome of menopause: A meta‑analysis of randomized controlled trials. ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/13697137.2025.2455186?af=R

Full article: Laser for genitourinary syndrome of menopause The evidence does not support the fractional CO 2 laser as an efficacious treatment for genitourinary syndrome of menopause (GSM).

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211517301483

Safety and long-term efficacy of fractional CO2 laser ... Eighty-four percent experienced significant improvement in their symptoms after CO2 laser treatment. Scores on measures of sexual function, dyspareunia, and ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37650754/

Long-term clinical and histological safety and efficacy of ... Long-term clinical and histological safety and efficacy of the CO2 laser for treatment of genitourinary syndrome of menopause: an original study.