Safety and Efficacy of a New Adjustable Single Incision Sling.pdf (626.38 kB)
Download fileThe Safety and Efficacy of a New Adjustable Single Incision Sling for Female Stress Urinary Incontinence
journal contribution
posted on 2015-02-02, 00:00 authored by E Kocjancic, L Tu, T Erickson, E Gheiler, D Van DriePurpose: 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.