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Mesh Sling

KIM vs TVT Sling for Stress Urinary Incontinence

Hillsborough, NC

N/A

Waitlist Available

Led By Christina Kunycky, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

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

Must have

Diagnosis of SUI or mixed urinary incontinence based on medical chart review

Planning surgery for SUI with/without pelvic organ prolapse (POP) surgery

Must not have

Bladder capacity <200 mL on Urodynamic testing or post-void residual (PVR) >150 mL on urodynamic testing or bladder scan.

Non-ambulatory

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the Neomedic Knotless Incontinence Mesh (KIM) sling to the Gynecare Tension-free Vaginal Tape (TVT) Exact sling in women 21 years or older with stress urinary incontinence (SUI) or mixed urinary incontinence (MUI).

Who is the study for?

This trial is for women aged 21 or older with stress urinary incontinence (SUI) or mixed urinary incontinence, who have evidence of SUI and are planning surgery. It's not for those currently pregnant, wanting future pregnancies, less than a year postpartum, with past SUI surgeries, low bladder capacity, high post-void residuals, non-ambulatory status or current genitourinary issues.

What is being tested?

The study compares two surgical methods to treat urinary incontinence: the Gynecare TVT Exact sling versus the Neomedic KIM sling. Women will be randomly assigned to one of these treatments and monitored for a year after surgery to see which is more effective.

What are the potential side effects?

Potential side effects from both slings may include discomfort at the site of surgery, infection risk due to the procedure itself, possible urinary problems like difficulty urinating or recurrent incontinence symptoms.

Eligibility Criteria

Inclusion Criteria

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

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My medical records show I have stress or mixed urinary incontinence.

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I am planning surgery for stress urinary incontinence with or without pelvic organ prolapse.

Exclusion Criteria

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

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My bladder holds less than 200 mL or doesn't empty well, leaving more than 150 mL.

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I cannot walk by myself.

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I have had surgery for stress urinary incontinence.

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I have a genitourinary fistula or urethral diverticulum.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants With Treatment Success at 6 Weeks After Surgery

Secondary study objectives

Number of Participants Requiring Reoperation for Mesh Complications or Urinary Retention Thru 1 Year After Surgery

Number of Participants With Mesh Exposure Thru 1 Year After Surgery

Number of Participants With Treatment Success at 1 Year After Surgery

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: Gynecare TVT Exact slingActive Control1 Intervention

Participants who are planning surgery for SUI are randomized to have placement of Gynecare TVT Exact sling and followed postoperatively for 1 year.

Group II: Neomedic KIM slingActive Control1 Intervention

Participants who are planning surgery for SUI are randomized to have placement of retropubic Neomedic KIM sling and followed postoperatively for 1 year.

0 / 6Eligibility criteria met