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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
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
1,504 Previous Clinical Trials
4,187,515 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My medical records show I have stress or mixed urinary incontinence.I am planning surgery for stress urinary incontinence with or without pelvic organ prolapse.I have been diagnosed with stress urinary incontinence in the last year.My bladder holds less than 200 mL or doesn't empty well, leaving more than 150 mL.I cannot walk by myself.I have had surgery for stress urinary incontinence.I have a genitourinary fistula or urethral diverticulum.You are pregnant, want to have a baby in the near future, or have given birth within the past year.I am a woman aged 21 or older.
Research Study Groups:
This trial has the following groups:- Group 1: Gynecare TVT Exact sling
- Group 2: Neomedic KIM sling
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current population size of participants in this study?
"Affirmative. According to clinicaltrials.gov, this medical study opened its doors for recruitment on August 11th 2021 and is still actively looking for new participants. A total of 214 individuals must join from two distinct locations in order to complete the trial's goals."
Answered by AI
Are new participants being enrolled in this research project currently?
"Affirmative, the clinical trial is still on-going and recruiting patients according to the information found on clinicaltrials.gov. This research was first made available on August 11th 2021 and has been modified since then; 214 individuals need to be enrolled from 2 distinct sites."
Answered by AI
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