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

Trial Summary

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 data supports the effectiveness of the treatment for menopausal urethral atrophy?

Research shows that fractional CO2 laser therapy can improve symptoms of vaginal atrophy, such as dryness and discomfort, and enhance quality of life and sexual function in postmenopausal women. It has also been effective in reducing urinary symptoms like incontinence. ^{1 2 3 4 5}

Is laser therapy safe for treating menopausal urethral atrophy?

Research on fractional CO2 laser therapy, used for similar conditions like vulvovaginal atrophy, suggests it is generally safe, with some studies noting improvements in symptoms and only minor side effects like pain and itching. However, more long-term studies are needed to fully understand its safety profile. ^{2 3 6 7 8}

How does laser therapy differ from other treatments for menopausal urethral atrophy?

Laser therapy for menopausal urethral atrophy is unique because it uses a fractional CO2 laser to improve symptoms by stimulating tissue regeneration, which can enhance quality of life and sexual function without the need for hormones. This makes it a potential alternative for women who cannot use hormone-based treatments, such as those with a history of breast cancer. ^{1 2 4 6 9}

What is the purpose of this trial?

Genitourinary Syndrome of Menopause (GSM) due to low estrogen levels affects about half of post-menopausal women and may have a dramatic impact on women's quality of life. Women complain of vaginal dryness, itching, discomfort, malodour, painful intercourse and may have urinary urgency, irritation, bladder/urethral pain and recurring bladder infections. First-line therapies include vaginal moisturizers, lubricants and estrogen (either oral or with vaginal cream/tablets). While these therapies are effective, the ongoing costs and the resistance to the indefinite use of vaginal creams/inserts is a challenge to the continued use of these therapies. Recently, an innovative laser therapy has been used to treat women with GSM. A randomized controlled trial (RCT) to study how effective the laser is to treat women with GSM is planned.

Research Team

Patricia Lee, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Iran 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. [2020]

2. Iran pubmed.ncbi.nlm.nih.gov

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

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

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

4. Japan pubmed.ncbi.nlm.nih.gov

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

5. United States 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. [2023]

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

Does the Time of Onset of Urinary Symptoms Affect Microablative Fractional CO2 Laser Efficacy in Postmenopausal Women? [2021]

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

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

9. England pubmed.ncbi.nlm.nih.gov

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