Comparing KIM to TVT Exact Sling

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.

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.