Mesh-Reduced Sling for Stress Urinary Incontinence

Overseen By Henry Chill, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Endeavor Health

Disqualifiers: Childbearing age, Previous SUI surgery

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

15 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this pilot study is to report the safety and efficacy of a suture-suspended mesh-reduced sling for treating stress urinary incontinence (SUI) in women. The main question\[s\] it aims to answer are: * investigate the efficacy of this mesh-reduced suture-based surgical technique for improving SUI symptoms * investigate the efficacy of this mesh-reduced suture-based surgical technique on key urethral support defects observed with 3D ultrasound Participants will consent to participate following which they will complete pre-operative assessments according to our routine clinical pathway. The participant will then undergo surgery and will be followed up to 12 months post-operatively via symptom assessment and pelvic exam.

Research Team

Henry Chill, MD

Principal Investigator

Endeavor Health

Eligibility Criteria

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.

Inclusion Criteria

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

Exclusion Criteria

I am a woman aged between 0 and 45.

I have had surgery for stress urinary incontinence before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative Assessment

Participants complete pre-operative assessments according to routine clinical pathway

1-2 weeks

1 visit (in-person)

Surgery

Participants undergo the mesh-reduced sling surgery for treating stress urinary incontinence

1 day

1 visit (in-person, hospital stay)

Postoperative Care

Standard postoperative care with discharge on the same day or after a brief hospital stay

1-2 days

Follow-up

Participants are monitored for safety and effectiveness after treatment with visits at 2 weeks, 2 months, and 12 months

12 months

3 visits (in-person)

Treatment Details

Interventions

• Mesh-reduced Sling

Trial Overview 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.

Participant Groups

Group I: Mesh-reduced Sling Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Endeavor Health

Lead Sponsor

Trials

135

Recruited

742,000+

NorthShore University HealthSystem

Lead Sponsor

Trials

134

Recruited

740,000+