Safety and Efficacy of a New Adjustable Single Incision Sling.pdf (626.38 kB)
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The Safety and Efficacy of a New Adjustable Single Incision Sling for Female Stress Urinary Incontinence

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journal contribution
posted on 02.02.2015 by E Kocjancic, L Tu, T Erickson, E Gheiler, D Van Drie
Purpose: We describe the safety and efficacy of the Altis Single Incision Sling System for the treatment of female stress urinary incontinence through 12 months. Materials and Methods: In this study we collected a variety of safety and efficacy measures relevant to the assessment of urinary incontinence. The primary effi- cacy end point was improvement in 24-hour pad weight test. Other efficacy measures included the cough stress test, Urogenital Distress Inventory-Short Form, Incontinence Impact Questionnaire-Short Form, Patient Global Impression of Improvement and 3-day voiding diary. Safety was evaluated through assessment of device and procedure related adverse events. Results: Of 116 surgical attempts 113 subjects were implanted with the Altis sling. Of these patients 103 had primary efficacy data at baseline and 6 months, and 101 had efficacy data at baseline and 12 months. Consequently 88 (85.4%) subjects at 6 months and 91 (90.1%) at 12 months achieved a 50% or greater reduction in pad weight. The cough stress test was negative for 95 (92.2%) subjects at 6 months and 91 (90.1%) at 12 months. A decrease in median leaks per day was observed at 6 months and improvements in all patient reported measures were observed through 12 months. A majority of subjects reported feeling much better or very much better at 6 and 12 months, respectively. There were no reports of mesh erosion or migration and no unanticipated adverse events through 12 months. Conclusions: The Altis sling appears to be safe and efficacious, and performs as intended in the treatment of stress urinary incontinence through 12 months.

Funding

Financial interest and/or other relationship with Coloplast

History

Publisher Statement

NOTICE: This is the author’s version of a work that was accepted for publication in Journal of urology. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in Journal of Urology.

Publisher

Elsevier

Issue date

01/11/2014

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