Comparing KIM to TVT Exact Sling

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Recruiting
CT.gov ID
NCT04985799
Collaborator
(none)
214
2
2
40.7
107
2.6

Study Details

Study Description

Brief Summary

To assess to the non-inferiority of the retropubic Neomedic Knotless Incontinence Mesh (KIM) sling compared to the Gynecare Tension-free Vaginal Tape (TVT) Exact sling.

Participants: Women 21 years or older with a diagnosis of stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) with objective evidence of SUI planning surgery for stress urinary incontinence.

Procedures (methods): Patients will be randomized to receive either the Gynecare TVT Exact sling or the retropubic Neomedic KIM sling. Patients will be followed for 1 year postoperatively.

Condition or Disease Intervention/Treatment Phase
  • Device: Gynecare TVT Exact Continence System
  • Device: Neomedic KIM (Knotless Incontinence Mesh)
N/A

Detailed Description

Midurethral slings (MUS) are recognized as a minimally invasive treatment of SUI. The retropubic route of MUS placement has a cure rate of 89.1% with long term subjective cure rates ranging from 51-88%. The Neomedic Knotless Incontinence Mesh (KIM) sling is a tension-free macroporous monofilament polypropylene knotless mesh designed to be resistant to elongation and deformation over time. The KIM sling also offers a reusable trocar, which results in less waste and cost- savings. KIM sling trocars are available for the retropubic route or trans-obturator (TOT) route.

While studies have been performed comparing the TOT approach of the KIM sling to other slings, no studies have been performed to date with the retropubic (RP) approach. The RP and TOT approaches to MUS have been shown to be equivalent in the treatment of SUI. Since the same mesh material of the KIM sling is used for both the TOT and RP approach, it can be hypothesis that the RP route would show similar treatment success rates.

A type 1 macroporous (> 75um) polypropylene mesh is the most appropriate material for vaginal implantation. However, literature has suggested that the design and weave of synthetic mesh material can also have a significant effect on efficacy and safety; therefore, the novel design of the KIM may be beneficial to reduce complications. If there is similar efficacy with the RP approach of the KIM sling to the TVT Exact, there will be benefit of reduced costs and the potential for less complications. With this study, the objective is to show non-inferiority of the KIM sling to the Gynecare TVT Exact.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
214 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial Comparing Retropubic KIM Sling to TVT Exact Midurethral Sling
Actual Study Start Date :
Aug 11, 2021
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Gynecare TVT Exact sling

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

Device: Gynecare TVT Exact Continence System
Participants will have placement of Gynecare TVT Exact sling.
Other Names:
  • Midurethral sling
  • Active Comparator: Neomedic KIM sling

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

    Device: Neomedic KIM (Knotless Incontinence Mesh)
    Participants will have placement of retropubic Neomedic KIM (Knotless Incontinence Mesh) sling
    Other Names:
  • Midurethral sling
  • Outcome Measures

    Primary Outcome Measures

    1. Proportion of Participants Considered a Treatment Success at 6 weeks [6 weeks]

      Treatment success will be defined on a subjective composite outcome: Response of "no" or "not at all bothered" to the following question: "Usually experience urine leakage related to coughing, sneezing or laughing?" Response of "very much better" or "much better" to the following question: "Check the number that best describes how your post-operative condition is now, compared with how it was before you had the surgery" No re-treatment (for example, with a pessary, other incontinence device or repeat surgery (urethral bulking, Burch urethropexy, sling, or other procedure)

    Secondary Outcome Measures

    1. Proportion of Participants with Complications [up to 1 year]

      Complications include mesh exposure, reoperation for urinary retention or mesh complications assessed at 6 weeks and 1 year postoperatively.

    2. Proportion of Participants Considered a Treatment Success [up to 1 year]

      Treatment success will be defined on a subjective composite outcome: Response of "no" or "not at all bothered" to the following question: "Usually experience urine leakage related to coughing, sneezing or laughing?" Response of "very much better" or "much better" to the following question: "Check the number that best describes how your post-operative condition is now, compared with how it was before you had the surgery" No re-treatment (for example, with a pessary, other incontinence device or repeat surgery (urethral bulking, Burch urethropexy, sling, or other procedure) Assessed at 6 months and 1 year postoperatively.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Women greater than or equal to 21 years based on medical chart review

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

    • Objective evidence of SUI as indicated by positive cough stress test or urodynamic stress incontinence during urodynamic testing within the last year prior to enrollment. Medical chart will be reviewed.

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

    Exclusion Criteria:
    • Current pregnancy, desire for future childbearing, less than or equal to 12 months postpartum at the time of enrollment

    • Prior history of surgery for SUI based on medical chart review

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

    • Non-ambulatory

    • Current genitourinary fistula or urethral diverticulum based on pre-operative exam in the medical chart.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UNC Hospitals Hillsborough Campus Hillsborough North Carolina United States 27278
    2 Rex Hospital Raleigh North Carolina United States 27607

    Sponsors and Collaborators

    • University of North Carolina, Chapel Hill

    Investigators

    • Principal Investigator: Jennifer Wu, MD, MPH, University of North Carolina, Chapel Hill
    • Principal Investigator: Samantha L Margulies, MD, University of North Carolina, Chapel Hill

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of North Carolina, Chapel Hill
    ClinicalTrials.gov Identifier:
    NCT04985799
    Other Study ID Numbers:
    • 21-1324
    First Posted:
    Aug 2, 2021
    Last Update Posted:
    Sep 14, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by University of North Carolina, Chapel Hill
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 14, 2021