title: Two-year outcomes for the Altis®adjustable single incision sling system for treatment of stress urinary incontinence.
abstract: OBJECTIVE
  Evaluate the Altis single-incision sling for treatment of female stress urinary incontinence through 24 months.
  
  
  METHODS
  This was a prospective, multi-center, industry-sponsored (Coloplast Corp.), single-arm trial with primary efficacy defined as ≥50% reduction in 24 h pad weight from baseline at 6-months. Device- and procedure-related complications were collected for safety. Secondary measures included cough stress test, Urogenital Distress Inventory-Short Form, Incontinence Impact Questionnaire-Short Form, and Patient Global Impression of Improvement.
  
  
  RESULTS
  Of the 113 women implanted, 94 remained at 24-months. The average procedure time was 12.8 ± 8.4 min across all settings. Of those with paired baseline and follow-up data at 24-months, 90.0% (81/90) achieved ≥50% reduction in pad weight, 81.1% (73/90) were dry (pad weight ≤4.0 g), and 87.9% (80/91) had a negative cough stress test. Significant median reductions of 44.4 in Urogenital Distress Inventory (P-value <0.0001) and 52.0 in Incontinence Impact Questionnaire scores (P-value <0.0001) were observed. Additionally, 90.4% (85/94) of subjects reported "very much better" or "much better" on the Patient Global Impression of Improvement. No new device- or procedure-related adverse events occurred between the 12 and 24 month visits.
  
  
  CONCLUSIONS
  The Altis single-incision sling is a durable and effective treatment with a favorable safety profile for surgical treatment of women with stress or stress-predominant mixed urinary incontinence.
authors: Department of Urology, University of Illinois at Chicago, Chicago, Illinois.
authors: Ervin
authors: E
authors: Kocjancic
authors: Rosemark Women Care Specialists, Idaho Falls, Idaho.
authors: Ty
authors: T
authors: Erickson
authors: Division of Urology, CHUS-Hôpital Fleurimont, Sherbrooke, Quebec.
authors: Le-Mai
authors: LM
authors: Tu
authors: Urology Specialists, LLC, Hialeah, Florida.
authors: Edward
authors: E
authors: Gheiler
authors: Female Pelvic Medicine and Urogynecology Institute of Michigan, Grand Rapids, Michigan.
authors: Douglas
authors: D
authors: Van Drie
mesh_terms: D000328:Adult; D000368:Aged; D001835:Body Weight; D005260:Female; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D053825:Suburethral Slings; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000601:surgery*
keywords: female; minimally invasive; stress; suburethral slings; surgical procedures; urinary incontinence