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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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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

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

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My bladder can hold at least 200cc of urine.

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I am a woman over 18 with stress urinary incontinence for at least 3 months.

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I can empty my bladder well and have minimal pelvic organ drop.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6,12 24 months post treatment

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

SUI cure

Secondary outcome measures

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,293 Total Patients Enrolled

Patricia Lee, MDPrincipal InvestigatorSunnybrook Health Sciences Centre

2 Previous Clinical Trials

200 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots in this research endeavor for participants?

"Affirmative. Records on clinicaltrials.gov show that this trial, initially posted on September 19th 2018, is currently recruiting patients in need of care. 182 people must be sourced from a single medical site for inclusion in the study."

Answered by AI

What is the cap on participant numbers for this clinical research?

"Affirmative. According to clinicaltrials.gov, recruiting for this investigation is still in progress and began on September 19th 2018. The trial has since been revised October 17th 2022 and 182 patients are being accepted at 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Laser Vaginal Treatment for SUI

2018. "Laser Vaginal Treatment for SUI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03671694.

All > Urinary Incontinence