MP37-08 PATIENT SATISFACTION AND QUALITY OF LIFE IN A MULTICENTER PROSPECTIVE STUDY OF SINGLE INCISION MINI-SLING (ALTIS®) IN THE MANAGEMENT OF FEMALE STRESS URINARY INCONTINENCE

Abstract

You have accessJournal of UrologyCME1 Apr 2023MP37-08 PATIENT SATISFACTION AND QUALITY OF LIFE IN A MULTICENTER PROSPECTIVE STUDY OF SINGLE INCISION MINI-SLING (ALTIS®) IN THE MANAGEMENT OF FEMALE STRESS URINARY INCONTINENCE Craig Hanson, Ty Erickson, and Rebecca Mccrery Craig HansonCraig Hanson More articles by this author , Ty EricksonTy Erickson More articles by this author , and Rebecca MccreryRebecca Mccrery More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003275.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To compare the non-inferiority of the Altis® Single Incision Sling (SIS) with standard midurethral transobturator and/or retropubic sling, including an evaluation of patient satisfaction, improvement in quality of life, return to normal, and pain at 6 months post surgery. METHODS: Prospective, nonrandomized FDA 522 cohort study comparing the Altis SIS to FDA cleared transobturator and/or retropubic slings for the treatment of stress urinary incontinence (SUI) through 36 months. Surgical Satisfaction Questionnaire (SSQ-8) for patient satisfaction at 6 months post surgery, Incontinence Impact Questionnaire (IIQ-7), Urodynamic Distress Inventory (UDI-6), and Visual Analog Scale (VAS) for pain were assessed at baseline and 6 months post surgery. RESULTS: 355 women underwent the sling procedure (Altis n=184 vs Comparator n=171). Subjects in both treatment groups had a high degree of satisfaction with their surgery as indicated on the SSQ-8 at 6 months Altis (n=165) 28.1±4.9 vs Comparator (n=148) 28.7±4.3 (p=0.257). There was no difference in satisfaction between groups in the amount of time to return to daily activities (p=0.877) and return to work (p=0.939). The IIQ-7 at 6 months indicated a trend of improvement in quality of life in both groups, of an average of 50%, with a mean change from baseline Altis (n=164) 50.6±25.3 vs Comparator (n=146) 49.9±27.9 (p=0.816). The UDI-6 at 6 months indicated an improvement in quality of life in both groups with a mean change from baseline Altis (n=164) 40.9±20.2 vs Comparator (n=145) 43.0±22.7 (p=0.387). Dyspareunia, de Novo, related to the procedure and/or device, was similar between groups (Altis 1.6% vs Comparator 1.2%, p=1.00). Pelvic/Urogenital Pain (Groin) was also similar between groups for all events (Altis 6.0% vs Comparator 2.9%, p=0.205). CONCLUSIONS: The patients had a high degree of satisfaction with their surgery and pain decreased similarly following either SIS or standard midurethral slings for treatment of SUI. Improvement in Quality of Life and Return to Normal increased similarly at 6 months following either SIS or Midurethral slings for treatment of SUI. Source of Funding: Coloplast funding for this FDA 522 required comparative trial. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e516 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Craig Hanson More articles by this author Ty Erickson More articles by this author Rebecca Mccrery More articles by this author Expand All Advertisement PDF downloadLoading ...