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Surgical Mesh

Mesh-Reduced Sling for Stress Urinary Incontinence

N/A

Recruiting

Led By Henry Chill, MD

Research Sponsored by NorthShore University HealthSystem

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptomatic stress urinary incontinence

Be older than 18 years old

Must not have

Previous stress urinary incontinence surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post-op

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new procedure to treat SUI in women, assessing its safety and effectiveness.

Who is the study for?

This trial is for women with stress urinary incontinence, which means they leak urine under pressure like coughing or lifting. It's not for women who can still have children (ages 0-45) or those who've had surgery for this issue before.

What is being tested?

The study tests a new surgical technique using a mesh-reduced sling to treat stress urinary incontinence. Women will be assessed before and up to one year after the operation, including symptom checks and pelvic exams.

What are the potential side effects?

While specific side effects are not listed, typical risks of such surgeries may include pain at the site, infection risk, bleeding, and potential complications related to the mesh material used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I experience urine leakage when I cough, sneeze, or exercise.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had surgery for stress urinary incontinence before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PFDI-20 score

Secondary study objectives

Complication measured by distal urethral swing angle

Complication measured by early and remote post-operative complications

Complication measured by proximal urethral swing angle

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Mesh-reduced SlingExperimental Treatment1 Intervention

Mesh-reduced sling will improve stress urinary incontinence (SUI) symptoms in women with SUI and normal urethral closure pressure at 2 months and 12 months after surgery.

0 / 2Eligibility criteria met