← Back to Search

Mesh Sling

KIM vs TVT Sling for Stress Urinary Incontinence

N/A
Waitlist Available
Led By Jennifer Wu, MD, MPH
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
My medical records show I have stress or mixed urinary incontinence.
Select...
I am planning surgery for stress urinary incontinence with or without pelvic organ prolapse.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment Success at 6 Weeks After Surgery
Secondary outcome measures
Number of Participants With Treatment Success at 1 Year After Surgery
Rate of Mesh Exposure Thru 1 Year After Surgery
Rate of Reoperation for Mesh Complications or Urinary Retention Thru 1 Year After Surgery

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.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,519 Previous Clinical Trials
4,195,733 Total Patients Enrolled
Jennifer Wu, MD, MPHPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
45 Total Patients Enrolled
Christina Kunycky, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Media Library

Gynecare TVT Exact Continence System (Mesh Sling) Clinical Trial Eligibility Overview. Trial Name: NCT04985799 — N/A
Stress Incontinence Research Study Groups: Gynecare TVT Exact sling, Neomedic KIM sling
Stress Incontinence Clinical Trial 2023: Gynecare TVT Exact Continence System Highlights & Side Effects. Trial Name: NCT04985799 — N/A
Gynecare TVT Exact Continence System (Mesh Sling) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04985799 — N/A
~39 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top