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Laser Vaginal Treatment for Stress Incontinence

N/A
Waitlist Available
Led By Patricia Lee, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The patient agrees to no new parallel treatment for SUI during the treatment period and the 6 months following it.
objective proof of SUI: Observation of urine leakage by cough and valsalva (positive stress test) at a bladder volume of ≤ 300cc
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6,12 24 months post treatment

Summary

This trialtests if laser treatment to the vagina improves urine control in women with Stress Urinary Incontinence.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of Erbium-YAG laser vaginal treatment may include discomfort during the procedure, redness, swelling, burning sensation post-treatment, and temporary increased urinary frequency or urgency.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I agree not to start any new treatments for stress urinary incontinence during and for 6 months after the study.
Select...
I have seen urine leak when I cough or exert pressure with a not full bladder.
Select...
My bladder can hold at least 200cc of urine.
Select...
I am a woman over 18 with stress urinary incontinence for at least 3 months.
Select...
I can empty my bladder well and have minimal pelvic organ drop.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6,12 24 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6,12 24 months post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
SUI cure
Secondary study objectives
Adverse effects

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: laser treatmentActive Control1 Intervention
Erbium-YAG laser treatment to the vagina
Group II: sham treatmentPlacebo Group1 Intervention
sham treatment with laser placebo

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
680 Previous Clinical Trials
1,565,722 Total Patients Enrolled
Patricia Lee, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
2 Previous Clinical Trials
200 Total Patients Enrolled
~20 spots leftby Dec 2025
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