Comparing KIM to TVT Exact Sling

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial Comparing Retropubic KIM Sling to TVT Exact Midurethral Sling

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Gynecare TVT Exact Continence System
* Device: Neomedic KIM (Knotless Incontinence Mesh)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gynecare TVT Exact sling<br>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<br>* Participants will have placement of Gynecare TVT Exact sling.<br>* Other names: Midurethral sling;|
| Active Comparator: Neomedic KIM sling<br>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)<br>* Participants will have placement of retropubic Neomedic KIM (Knotless Incontinence Mesh) sling<br>* Other names: Midurethral sling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 1 year | 
| Rate of Reoperation for Mesh Complications or Urinary Retention Thru 1 Year After Surgery |  | up to 1 year | 
| Rate of Mesh Exposure Thru 1 Year After Surgery |  | up to 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress urinary incontinence, Mixed urinary incontinence, Midurethral sling