PURPOSE: The purpose of this report is to describe the safety and efficacy of the Altis® Single Incision Sling System (Altis sling) for treatment of female stress urinary incontinence through 12 months.
MATERIALS AND METHODS: This study collected a variety of safety and efficacy measures relevant to assessment of urinary incontinence. The primary efficacy endpoint was improvement in 24-hour pad weight test. Other efficacy measures included 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. 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 ≥50% 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. 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, efficacious, and performs as intended in the treatment of stress urinary incontinence through 12 months.
Written by:
Kocjancic E, Tu LM, Erickson T, Gheiler E, Van Drie D. Are you the author?
University of Illinois at Chicago, Chicago, IL; Hôpital Fleurimont, Sherbrooke, QC; Rosemark Women Care Specialists, Idaho Falls, ID; Urology Specialists, LLC, Hialeah, FL; Female Pelvic Medicine & Urogynecology Institute of MI, Grand Rapids, MI.
Reference: J Urol. 2014 Jun 4. pii: S0022-5347(14)03715-X.
doi: 10.1016/j.juro.2014.05.101
PubMed Abstract
PMID: 24907444
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