At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Controlled Trial Comparing Retropubic KIM Sling to TVT Exact Midurethral Sling
In Brief
A clinical study evaluating Gynecare TVT Exact Continence System and Neomedic KIM (Knotless Incontinence Mesh) for Stress Urinary Incontinence. Completed, enrolled 147 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Participants will have placement of Gynecare TVT Exact sling.
Participants will have placement of retropubic Neomedic KIM (Knotless Incontinence Mesh) sling