An interventional study of Gynecare TVT Exact Continence System and Neomedic KIM (Knotless Incontinence Mesh) in Stress Urinary Incontinence, sponsored by University of North Carolina, Chapel Hill. Completed at 2 sites in United States. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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.
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.
670 studies on the registry are indexed under Urinary Incontinence, Stress; 122 are open to participants now.
This study's enrollment of 147 is above the median of 69 across 520 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,366 studies on the registry; 133 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 139 (88%) have results posted.
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Exclusion Criteria:
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 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 Gynecare TVT Exact sling.
Also known as: Midurethral sling
Participants will have placement of retropubic Neomedic KIM (Knotless Incontinence Mesh) sling
Also known as: Midurethral sling
Number of Participants With Treatment Success at 6 Weeks After Surgery
Treatment success is defined by a composite outcome of 1) response of No or "no bother" to question #3 on urogenital distress inventory-6 (UDI-6) validated questionnaire AND no retreatment of stress incontinence.
Time frame: 6 weeks after surgery
Number of Participants With Treatment Success at 1 Year After Surgery
Treatment success is defined by a composite outcome of 1) response of No or "no bother" to question #3 on urogenital distress inventory-6 (UDI-6) validated questionnaire AND no retreatment of stress incontinence.
Time frame: up to 1 year
Number of Participants Requiring Reoperation for Mesh Complications or Urinary Retention Thru 1 Year After Surgery
Reoperation for mesh complications or urinary retention thru 1 year after initial sling surgery
Time frame: up to 1 year
Number of Participants With Mesh Exposure Thru 1 Year After Surgery
Sling mesh exposure identified on examination thru 1 year after surgery
Time frame: up to 1 year after surgery
| Milestone | Gynecare Tension-free Vaginal Tape (TVT) Exact Sling | Neomedic Knotless Incontinence Mesh (KIM) Sling |
|---|---|---|
| Started | 73 | 74 |
| Completed | 73 | 74 |
| Not completed | 0 | 0 |
Treatment success is defined by a composite outcome of 1) response of No or "no bother" to question #3 on urogenital distress inventory-6 (UDI-6) validated questionnaire AND no retreatment of stress incontinence.
| Participants | Gynecare Tension-free Vaginal Tape (TVT) Exact Sling | Neomedic Knotless Incontinence Mesh (KIM) Sling |
|---|---|---|
| Number of Participants With Treatment Success at 6 Weeks After Surgery | 61 | 51 |
Treatment success is defined by a composite outcome of 1) response of No or "no bother" to question #3 on urogenital distress inventory-6 (UDI-6) validated questionnaire AND no retreatment of stress incontinence.
| Participants | Gynecare TVT Exact Sling | Neomedic KIM Sling |
|---|---|---|
| Number of Participants With Treatment Success at 1 Year After Surgery | 55 | 53 |
Reoperation for mesh complications or urinary retention thru 1 year after initial sling surgery
| Participants | Gynecare TVT Exact Sling | Neomedic KIM Sling |
|---|---|---|
| Number of Participants Requiring Reoperation for Mesh Complications or Urinary Retention Thru 1 Year After Surgery | 0 | 0 |
Sling mesh exposure identified on examination thru 1 year after surgery
| Participants | Gynecare TVT Exact Sling | Neomedic KIM Sling |
|---|---|---|
| Number of Participants With Mesh Exposure Thru 1 Year After Surgery | 6 | 1 |
Collected over Adverse events are reported from after surgery until 1 year postoperative visit.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gynecare TVT Exact Sling | 0/73 (0%) | 0/73 (0%) | 9/73 (12.3%) |
| Neomedic KIM Sling | 0/74 (0%) | 0/74 (0%) | 6/74 (8.1%) |
| Event | Gynecare TVT Exact Sling | Neomedic KIM Sling |
|---|---|---|
| Mesh exposureRenal and urinary disorders | 6/73 | 1/74 |
| Urinary retentionRenal and urinary disorders | 3/73 | 5/74 |
| Age, Continuous(years) | Gynecare Tension-free Vaginal Tape (TVT) Exact Sling | Neomedic Knotless Incontinence Mesh (KIM) Sling | Total |
|---|---|---|---|
| Mean | 58.0 ± 12.7 | 59.7 ± 12.1 | 58.9 ± 12.4 |
| Sex: Female, Male(Participants) | Gynecare Tension-free Vaginal Tape (TVT) Exact Sling | Neomedic Knotless Incontinence Mesh (KIM) Sling | Total |
|---|---|---|---|
| Female | 73 | 74 | 147 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Gynecare Tension-free Vaginal Tape (TVT) Exact Sling | Neomedic Knotless Incontinence Mesh (KIM) Sling | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 8 | 15 |
| White | 63 | 62 | 125 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 3 | 6 |
| Region of Enrollment(Participants) | Gynecare Tension-free Vaginal Tape (TVT) Exact Sling | Neomedic Knotless Incontinence Mesh (KIM) Sling | Total |
|---|---|---|---|
| United States | 73 | 74 | 147 |
| Diabetes(Participants) | Gynecare Tension-free Vaginal Tape (TVT) Exact Sling | Neomedic Knotless Incontinence Mesh (KIM) Sling | Total |
|---|---|---|---|
| Count of participants | 6 | 8 | 14 |
| Current smoker(Participants) | Gynecare Tension-free Vaginal Tape (TVT) Exact Sling | Neomedic Knotless Incontinence Mesh (KIM) Sling | Total |
|---|---|---|---|
| Count of participants | 9 | 10 | 19 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina (UNC)
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 9 to 36 months following publication
Access criteria: Approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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