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The estimated prevalence of urinary incontinence (UI) in females varies widely, from 15% to 69%, and is additionally presumed to be underreported because of under-evaluation as well as stigma associated with it. Stress urinary incontinence (SUI) is reported to affect between 50% and 80% of cases of UI. Significant impacts on quality of life (QoL) in both personal and social aspects are common in SUI, and previous research has shown high rates of anxiety and depression. Current treatments for SUI include management of symptoms as well as surgical management, including midurethral sling (MUS) and single incision sling (SIS) procedures. This study was designed to compare the safety and effectiveness of the Altis SIS with other full-length slings for the treatment of SUI. An additional goal of this study was to compare QoL before and after surgery over the course of 36 months. This was a secondary analysis of data from the Altis 522 study, which was a prospective, multicenter, nonrandomized, noninferiority cohort study. The primary outcomes of the initial study were patient-reported success as measured by 24-hour pad weight reduction and serious adverse events at 6 months and through 36 months. QoL was measured at 6, 12, 18, 24, and 36 months. The inclusion and exclusion criteria have been previously reported. The final analysis included 355 patients recruited between January 2015 and May 2018. At 36-month follow-up, assessment was performed for 140 patients with the Altis SIS and 101 patients with full-length slings in the control group. The patients who received Altis SIS were older and more likely to be postmenopausal compared with controls. The control group had a higher body mass index, reported more current smoking, and had higher baseline urinary distress scores, as well as a larger proportion of individuals with mixed urinary incontinence. The Urogenital Distress Inventory (UDI-6) showed no significant differences between the Altis SIS and control groups at 36-month follow-up, with both groups showing significant improvement. The Incontinence Impact Questionnaire (IIQ-7) also showed no significant difference between groups at 36-month follow-up, with similarly improved scores in both groups. The same was true of the Patient Global Impression of Improvement (PGI-I) and the Surgical Satisfaction Questionnaire (SSQ-8). These results indicate that the Altis SIS performed very similarly to controls with full-length slings for treatment of SUI, even at long-term follow-up. Both groups demonstrated meaningful improvement in QoL, and each questionnaire showed improvement. This is consistent with previous literature assessing improvement in QoL over objective cure rate. There is some potential for patient satisfaction to be affected by adverse events, and this was the case in a small number of patients in this study. Future research should focus on ways to reduce the occurrence of adverse events as well as assessing the impact of SIS on other related conditions or in high-risk subgroups. In addition, future research should allow patients to complete questionnaires at their convenience to reduce pressure and burden on enrolled patients.
Published in: Obstetrical & Gynecological Survey
Volume 81, Issue 1, pp. 21-21