Laser Vaginal Treatment for Stress Incontinence

Overseen By Joanne Lawrence, BSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Pregnancy, Urgency UI, Pelvic surgery, others

Compensation: Varies

Number of Visits: 6

Duration: 6 months

144 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must agree to no new treatments for stress urinary incontinence during the trial and for 6 months after.

What data supports the effectiveness of the treatment Erbium-YAG laser vaginal treatment for stress incontinence?

Research shows that the Erbium-YAG laser treatment can significantly reduce symptoms of stress urinary incontinence in women, with improvements in quality of life and no reported complications. ^{1 2 3 4 5}

Is laser vaginal treatment for stress incontinence safe?

Research shows that Erbium-YAG laser treatment for stress urinary incontinence is generally safe, with studies reporting no significant complications and an acceptable safety profile. ^{3 5 6 7 8}

How does Erbium-YAG laser treatment differ from other treatments for stress urinary incontinence?

The Erbium-YAG laser treatment is unique because it is a non-invasive, non-surgical option that uses laser energy to heat and remodel collagen in the vaginal tissue, improving its tightness and elasticity. This approach differs from traditional surgical methods or medications, offering a less invasive alternative with potentially fewer side effects. ^{1 2 7 8 9}

What is the purpose of this trial?

RCT designed to answer the question: Does the application of Erbium: YAG laser treatment to the vagina improve urine control for women with SUI?

Research Team

Patricia Lee, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

This trial is for women over 18 with Stress Urinary Incontinence (SUI), confirmed by medical history and tests showing urine leakage on coughing or straining. Participants must have had SUI symptoms for at least 3 months, not be undergoing other SUI treatments during the study, and have a bladder that can hold at least 200cc of urine.

Inclusion Criteria

I agree not to start any new treatments for stress urinary incontinence during and for 6 months after the study.

I have seen urine leak when I cough or exert pressure with a not full bladder.

My bladder can hold at least 200cc of urine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Erbium-YAG laser treatment or sham treatment to the vagina

6 months

Regular visits as per trial protocol

Open-label extension

Sham treatment arm participants who do not meet treatment success may receive the active treatment

Following 6-month evaluation

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Follow-up visits at 6, 12, and 24 months post treatment

Treatment Details

Interventions

• Erbium-YAG laser vaginal treatment

Trial Overview The trial is testing if Erbium-YAG laser treatment applied to the vagina helps control urination in women with SUI. It's a randomized controlled trial (RCT), meaning participants are randomly assigned to receive either the laser treatment or no treatment as a comparison.

Participant Groups

Group I: laser treatment Active Control 1 Intervention

Erbium-YAG laser treatment to the vagina

Group II: sham treatment Placebo Group 1 Intervention

sham treatment with laser placebo

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

References

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

Vaginal therapy of mild and moderate stress urinary incontinence using Er:YAG laser: a real treatment option. [2020]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Outcomes of ER:YAG LASER treatment of stress urinary incontinence in women]. [2019]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[APPLICATION OF LASER TECHNOLOGIES FOR TREATMENT OF URINARY STRESS INCONTINENCE IN WOMEN OF REPRODUCTIVE AGE]. [2015]

4. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Preliminary outcome of non-ablative vaginal Erbium laser treatment for female stress and mixed urinary incontinence. [2020]

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

Vaginal erbium laser treatment for stress urinary incontinence: A multicenter randomized sham-controlled clinical trial. [2023]

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

First assessment of short-term efficacy of Er:YAG laser treatment on stress urinary incontinence in women: prospective cohort study. [2022]

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

Baseline ICIQ-UI score, body mass index, age, average birth weight, and perineometry duration as promising predictors of the short-term efficacy of Er:YAG laser treatment in stress urinary incontinent women: A prospective cohort study. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Erbium laser in gynecology. [2015]

9. India pubmed.ncbi.nlm.nih.gov

Treating Vaginal Relaxation Syndrome Using Erbium: Yttrium Aluminum Garnet Fractional Laser: A Retrospective Study. [2022]