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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Erbium-YAG laser vaginal treatment can help women with stress urinary incontinence (SUI) improve urine control. Participants will receive either the actual laser treatment or a placebo treatment with no real laser effect to determine any noticeable difference. Women experiencing SUI symptoms for at least three months, with a confirmed diagnosis through medical history and tests, might qualify. Participants should not begin any new treatments for SUI during the trial and for six months afterward. As an unphased trial, this study provides a unique opportunity to explore a novel treatment option for SUI.

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 prior data suggests that this laser treatment is safe for vaginal application?

Research has shown that Erbium:YAG laser treatment for stress urinary incontinence (SUI) is generally safe and manageable for patients. Studies have found only mild and short-lasting side effects. For instance, one study noted that about 4.5% of patients experienced a urinary infection, while others reported mild pain. These effects were temporary and not serious.

Additionally, other research confirms that this laser treatment is safe and minimally invasive. Patients typically tolerate it well, with no major long-term problems reported. Overall, the evidence suggests that this treatment is safe for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for stress incontinence, which often involve medications, pelvic floor exercises, or surgery, the Erbium-YAG laser treatment offers a non-invasive option. This laser therapy targets the vaginal tissue to stimulate collagen production and improve tissue tone, potentially reducing incontinence symptoms without the need for surgical intervention. Researchers are excited because this method could provide quicker recovery times and fewer side effects compared to more invasive procedures, making it a promising alternative for those seeking less intensive treatment.

What evidence suggests that Erbium-YAG laser treatment is effective for stress incontinence?

Research has shown that the Erbium: YAG laser treatment, which participants in this trial may receive, may help women with stress urinary incontinence (SUI), a condition where urine leaks during activities like coughing or exercising. Some studies found that this laser treatment improved urine control more than a sham treatment, which is another arm in this trial. However, other research suggests the laser might not significantly alleviate SUI symptoms. In some cases, the treatment did not show strong improvement after six months. Overall, the evidence is mixed, so results can vary. ^{2 3 6 7 8}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37927157/

Vaginal erbium laser treatment for stress urinary incontinence Conclusion: Non-ablative vaginal Er:YAG laser therapy significantly improves SUI symptoms versus sham treatment. Er:YAG laser therapy should be ...

2. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1002/ijgo.15222

Vaginal erbium laser treatment for stress urinary incontinence ... Non-ablative vaginal Er:YAG laser therapy significantly improves SUI symptoms versus sham treatment. Er:YAG laser therapy should be considered ...

3. link.springer.com link.springer.com/article/10.1007/s00192-025-06160-8

Vaginal Laser Treatment on Stress Urinary Incontinence This study evaluates the efficacy of vaginal Erbium:YAG laser treatment for stress urinary incontinence (SUI) compared with sham treatment over 12 months.

4. auajournals.org auajournals.org/doi/10.1097/JU.0000000000004691

Vaginal Lasers for Treating Stress Urinary Incontinence in ... Vaginal lasers may have little to no effect on SUI as measured by both clinical assessment in the short term compared with sham, control, or topical treatments, ...

5. ajog.org ajog.org/article/S0002-9378(24)01160-8/fulltext

YAG vaginal laser to treat female stress urinary incontinence In this trial, we found a very low subjective cure rate with Er: YAG laser for female SUI at 6 months after treatment. In addition, there was no significant ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10492687/

Efficacy and safety of intraurethral Erbium:YAG laser ... The treatment was well-tolerated, with mild and transient adverse effects such as urinary infection in 1 patient (4.5%) and mild pain in 7 ...

7. apm.amegroups.org apm.amegroups.org/article/view/61266/html

Safety and efficacy of vaginal laser therapy for stress urinary ... Vaginal laser therapy appears to be a safe, effective, and minimally invasive treatment option for SUI that can be well tolerated by patients.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35067817/

Vaginal erbium laser for treatment of stress urinary ... All reported side effects were mild and transient. The application of non-ablative Er:YAG laser for SUI treatment significantly improves the SUI ...