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
Introduction: 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.
