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The Safety and Efficacy of a New Adjustable Single Incision Sling for Female Stress Urinary Incontinence

2014; Lippincott Williams & Wilkins; Volume: 192; Issue: 5 Linguagem: Inglês

10.1016/j.juro.2014.05.101

1527-3792

Ervin Kocjancic, Le‐Mai Tu, Ty Erickson, Edward L. Gheiler, Douglas Van Drie,

Urinary Tract Infections Management

No AccessJournal of UrologyAdult Urology1 Nov 2014The Safety and Efficacy of a New Adjustable Single Incision Sling for Female Stress Urinary Incontinence Ervin Kocjancic, Le-Mai Tu, Ty Erickson, Edward Gheiler, and Douglas Van Drie Ervin KocjancicErvin Kocjancic University of Illinois at Chicago, Chicago, Illinois , Le-Mai TuLe-Mai Tu Hôpital Fleurimont, Sherbrooke, Quebec, Canada , Ty EricksonTy Erickson Rosemark Women Care Specialists, Idaho Falls, Idaho , Edward GheilerEdward Gheiler Urology Specialists, LLC, Hialeah, Florida , and Douglas Van DrieDouglas Van Drie Female Pelvic Medicine & Urogynecology Institute of Michigan, Grand Rapids, Michigan View All Author Informationhttps://doi.org/10.1016/j.juro.2014.05.101AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract 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 efficacy 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. References 1 : Urinary incontinence in US women: a population-based study. Arch Intern Med2005; 165: 537. Google Scholar 2 : Variation in estimates of urinary incontinence prevalence in the community: effects of differences in definition, population characteristics, and study type. J Am Geriatr Soc1998; 46: 473. Google Scholar 3 : Definition of overactive bladder and epidemiology of urinary incontinence. Urology1997; 50: 4. 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Available at www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070852.htm. Google Scholar 14 : A strength comparison of immediate and delayed extraction forces of five different single incision slings anchor types: an animal model. Int Urogynecol J Pelvic Floor Dysfunct2012; 23: S115. Google Scholar 15 : Initial assessment of urinary incontinence in adult male and female patients. In: Incontinence. Edited by . : ICUD-EAU2013. chapt 5A, p 374. Google Scholar © 2014 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 192Issue 5November 2014Page: 1477-1482 Advertisement Copyright & Permissions© 2014 by American Urological Association Education and Research, Inc.Keywordsstressurinary incontinencesuburethral slingsfemalesurgical proceduresminimally invasiveMetrics Author Information Ervin Kocjancic University of Illinois at Chicago, Chicago, Illinois More articles by this author Le-Mai Tu Hôpital Fleurimont, Sherbrooke, Quebec, Canada More articles by this author Ty Erickson Rosemark Women Care Specialists, Idaho Falls, Idaho More articles by this author Edward Gheiler Urology Specialists, LLC, Hialeah, Florida More articles by this author Douglas Van Drie Female Pelvic Medicine & Urogynecology Institute of Michigan, Grand Rapids, Michigan More articles by this author Expand All Advertisement PDF downloadLoading ...