Urogynecology (Philadelphia, Pa.) · 2024
Noninferiority Randomized Clinical Trial: KIM Sling With Reusable Trocars Versus TVT Exact Sling.
Сравнительное исследованиеEquivalence TrialСтатьяНазвание и аннотация: Перевод в очереди
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Margulies Samantha L, Osment Anna E, Bernard Adele, Schroeder Michelle N, Askew Amy L, Agu Ijeoma S, Kunycky Christina A, Geller Elizabeth J, Willis-Gray Marcella, Chu Christine M, Wu Jennifer M
Аннотация
IMPORTANCE: The Neomedic Knotless Incontinence Mesh (KIM) sling with sterilizable trocars decreases medical waste versus midurethral slings with disposable trocars. Limited comparative data exist.
OBJECTIVE: The aim of the study was to assess to the success of the retropubic KIM sling compared to the Gynecare TVT Exact sling.
STUDY DESIGN: This was a single-center, randomized noninferiority trial comparing outcomes of 2 retropubic slings-KIM sling and TVT Exact sling-in women with stress urinary incontinence from August 2021 to May 2023. Primary outcome was subjective success at 6 weeks defined by a composite outcome of the response to the question #17 on the The Pelvic Floor Distress Inventory-20 questionnaire and no retreatment of stress urinary incontinence. Secondary outcomes included rates of urinary retention, mesh erosion, and reoperation for mesh complications. Sample size estimate based on noninferiority margin of 14%, equal success of 90%, alpha 0.05, and 80% power with a 20% dropout was 72 per group.
RESULTS: Among 147 patients, 74 (50.3%) were randomized to KIM sling versus 73 (49.7%) to TVT exact. The rates of 6-week success were 68.5% for the KIM sling and 83.3% for the TVT exact with a risk difference 14.8% (95% confidence interval, 1.1-28.5). The KIM sling is not noninferior to the TVT Exact sling. There were no differences in secondary outcomes.
CONCLUSIONS: The KIM sling is not noninferior to the TVT Exact sling for success at 6 weeks based on a composite outcome score. This clinical trial is ongoing to assess outcomes at 6 months and 1 year. ( Clinicaltrials.gov NCT04985799).
OBJECTIVE: The aim of the study was to assess to the success of the retropubic KIM sling compared to the Gynecare TVT Exact sling.
STUDY DESIGN: This was a single-center, randomized noninferiority trial comparing outcomes of 2 retropubic slings-KIM sling and TVT Exact sling-in women with stress urinary incontinence from August 2021 to May 2023. Primary outcome was subjective success at 6 weeks defined by a composite outcome of the response to the question #17 on the The Pelvic Floor Distress Inventory-20 questionnaire and no retreatment of stress urinary incontinence. Secondary outcomes included rates of urinary retention, mesh erosion, and reoperation for mesh complications. Sample size estimate based on noninferiority margin of 14%, equal success of 90%, alpha 0.05, and 80% power with a 20% dropout was 72 per group.
RESULTS: Among 147 patients, 74 (50.3%) were randomized to KIM sling versus 73 (49.7%) to TVT exact. The rates of 6-week success were 68.5% for the KIM sling and 83.3% for the TVT exact with a risk difference 14.8% (95% confidence interval, 1.1-28.5). The KIM sling is not noninferior to the TVT Exact sling. There were no differences in secondary outcomes.
CONCLUSIONS: The KIM sling is not noninferior to the TVT Exact sling for success at 6 weeks based on a composite outcome score. This clinical trial is ongoing to assess outcomes at 6 months and 1 year. ( Clinicaltrials.gov NCT04985799).