Laser Therapy for Menopausal Urethral Atrophy

Overseen By Razia Sultana, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Antibiotics

Disqualifiers: Pregnancy, Abnormal bleeding, Infections, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new laser therapy for women experiencing symptoms of Genitourinary Syndrome of Menopause (GSM), a condition caused by low estrogen levels after menopause. GSM can lead to vaginal dryness, itching, and bladder problems. The study compares the effects of the laser treatment to a sham (fake) treatment to evaluate its effectiveness. Women at least two years past menopause who experience symptoms like dryness or pain once a week may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for GSM symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you cannot start any new treatments for GSM during the trial and for 3 months after. If you are using any GSM treatments, you may need to stop them.

What prior data suggests that this laser therapy is safe for treating menopausal urethral atrophy?

Research has shown that laser treatments for menopausal urethral atrophy are usually well-tolerated. For example, studies have found that a fractional CO2 laser can safely reduce symptoms like vaginal dryness and discomfort. In one study, 84% of participants reported significant improvement in their symptoms after receiving the laser treatment.

However, not everyone experiences positive outcomes. Some reports mention that a few women have experienced side effects like vaginal pain and scarring. These cases are rare but important to consider. Overall, while many find relief with laser therapy, there is a small risk of side effects. It is important to weigh the potential benefits and risks when considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Laser vaginal treatment is unique because it offers a non-hormonal approach to addressing menopausal urethral atrophy. Unlike traditional treatments that often involve hormone replacement therapy, which can have systemic effects, laser therapy specifically targets the affected tissue to stimulate collagen production and rejuvenate the area. Researchers are excited about this treatment because it provides a localized solution with the potential for fewer side effects, and it may improve symptoms more quickly compared to conventional methods.

What evidence suggests that laser vaginal treatment is effective for genitourinary syndrome of menopause?

Research has shown that laser vaginal treatment, which participants in this trial may receive, can help women with symptoms of Genitourinary Syndrome of Menopause (GSM). One study found that most symptoms improved significantly just one month after the first laser treatment, with even more improvement by three months. Another study compared this laser therapy to traditional estrogen treatment and found both to be effective, suggesting laser therapy as a promising alternative. Additionally, laser treatment has improved quality of life by enhancing sexual function and reducing symptoms like vaginal dryness and discomfort. Overall, these studies suggest that laser therapy could be a helpful option for managing GSM symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Patricia Lee, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for post-menopausal women aged 45-70 with Genitourinary Syndrome of Menopause (GSM), experiencing symptoms like vaginal dryness or pain. Participants must not be pregnant, have had recent pelvic surgery, or use other GSM treatments.

Inclusion Criteria

It has been over 2 years since my last period or I've had my ovaries removed.

My vaginal anatomy is suitable for laser therapy.

I am not planning to treat GSM during or 3 months after the trial.

Exclusion Criteria

I am currently being treated for chronic pelvic pain.

I have not had pelvic surgery in the last 3 months.

I currently have a vaginal or bladder infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either laser treatment or sham treatment for GSM

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Laser Vaginal Treatment

Trial Overview The study tests laser vaginal treatment's effectiveness on GSM symptoms compared to standard therapies. It's a randomized controlled trial, meaning participants are randomly assigned to receive either the laser treatment or a placebo/control condition.

How Is the Trial Designed?

Group I: laser treatment Active Control 1 Intervention

Group II: sham treatment Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario

Collaborator

Trials

2

Recruited

220+

Published Research Related to This Trial

Transvaginal fractional microablative CO2 laser therapy (MLT) is safe and effective for treating urinary symptoms and vulvovaginal atrophy (VVA) in postmenopausal women, with significant improvements observed in urinary symptoms for those whose symptoms began after menopause.

In a study of 61 women, MLT significantly improved urinary frequency and urgency incontinence, particularly in those with symptoms starting after menopause, while all VVA symptoms also showed significant improvement without any recorded adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the Time of Onset of Urinary Symptoms Affect Microablative Fractional CO2 Laser Efficacy in Postmenopausal Women? Ruffolo, AF., Casiraghi, A., Marotta, E., et al.[2021]

A study involving 140 post-menopausal women showed that treatment with fractional CO2 laser significantly improved symptoms of vaginal atrophy and urinary incontinence after three sessions, enhancing overall quality of life and sexual function.

Participants reported notable improvements in somatic, social, and mental health aspects, as well as in sexual arousal and satisfaction, indicating the laser's efficacy in addressing both physical and emotional challenges associated with menopause.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the Fractional CO2 Laser on the Quality of Life, General Health, and Genitourinary Symptoms in Postmenopausal Women With Vaginal Atrophy: A Prospective Cohort. Adabi, K., Golshahi, F., Niroomansh, S., et al.[2020]

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]

Transvaginal laser therapies, particularly using erbium-doped yttrium aluminum garnet and CO2 lasers, have shown effectiveness in relieving symptoms of vulvovaginal atrophy in menopausal women, with benefits lasting at least 12 months and generally well-tolerated procedures.

Despite the promising results, many studies are small and of low quality, leading to a recommendation that vaginal laser therapy should primarily be used in clinical trials until more definitive evidence is available, especially regarding its role in treating conditions like stress urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lasers in the era of evidence-based medicine. Hillard, TC.[2021]

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]

In a study of 139 women with vulvovaginal atrophy, fractional microablative CO2 laser therapy significantly improved sexual function and reduced symptoms like painful intercourse and vulvar dryness after three treatments, with no major adverse events reported.

The therapy led to notable improvements in validated questionnaire scores, with FSFI scores increasing from 12.7 to 19.0 and significant enhancements in 18 out of 21 questions on the Vulvovaginal Symptoms Questionnaire.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The short-term efficacy and safety of fractional CO2 laser therapy for vulvovaginal symptoms in menopause, breast cancer, and lichen sclerosus. Gardner, AN., Aschkenazi, SO.[2023]

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 18 postmenopausal women, three monthly fractional CO2 laser treatments significantly improved vaginal health and sexual function, with benefits lasting up to 12 months as measured by the Vaginal Health Index (VHI) and Female Sexual Function Index (FSFI).

The treatment was particularly effective in women who were recently postmenopausal (1-3 years), with 88% achieving normal or near-normal VHI scores at 3 and 6 months, compared to only 10% in those postmenopausal for over 3 years, indicating that earlier intervention may lead to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional Co2 Laser Treatment of the Vulva and Vagina and the Effect of Postmenopausal Duration on Efficacy. Alexiades, MR.[2021]

In a study of 28 postmenopausal women, fractional CO2 laser treatment significantly improved symptoms of vulvovaginal atrophy (VVA) after just one session, with continued improvement observed at 3 and 6 months after three treatments.

The therapy not only alleviated VVA symptoms but also enhanced sexual function, as indicated by a significant increase in the Female Sexual Function Index (FSFI) scores from baseline to follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early effect of fractional CO2 laser treatment in Post-menopausal women with vaginal atrophy. Eder, SE.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5958234/

Early effect of fractional CO2 laser treatment in Post- ... Almost all VVA symptoms were significantly improved at one month following the first treatment. A further significant improvement in VVA symptoms was noted at 3 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772973724009998

Vaginal LASER and estrogen comparison in Genitourinary ... This study aims to compare the efficacy of CO2 fractionated laser therapy and topical estrogen treatment in managing Genitourinary Syndrome of Menopause (GSM).

3. 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.

4. sociedadperuanaclimaterio.com sociedadperuanaclimaterio.com/assets/uploads/2024/08/healthcare-12-01385.pdf

Multifaceted Impact of CO2 Laser Therapy on ... The laser treatment resulted in a decrease in VHIS and patient-reported vulvovaginal atrophy (VVA) symptoms, with a significantly lower ...

5. mdpi.com mdpi.com/1648-9144/60/7/1059

Understanding the Benefits of CO2 Laser Treatment for ... Our study revealed that fractional CO 2 laser is a useful treatment option to alleviate VVA symptoms and improve vaginal health and sexual functioning in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7456654/

Long-Term Safety and Efficacy of Fractional CO2 Laser ... In conclusion, the results suggest that fractional CO2 laser treatments are safe, well-tolerated and effective in alleviating symptoms of VVA and sexual ...

7. 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 ...

8. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/aogs.14353

The evidence behind the use of LASER for genitourinary ... LASER technology is not yet recommended for routine treatment of genitourinary syndrome of menopause, vulvovaginal atrophy, urinary incontinence ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6435398/

Women harmed by vaginal laser for treatment of GSM—the ... In this issue of Menopause, Gordon and colleagues describe four additional menopausal women who suffered vaginal pain, scarring and sexual dysfunction following ...

10. mdpi.com mdpi.com/2227-9032/12/14/1385

Multifaceted Impact of CO2 Laser Therapy on ... The laser treatment resulted in a decrease in VHIS and patient-reported vulvovaginal atrophy (VVA) symptoms, with a significantly lower ...