Incontinence outcomes in women undergoing retropubic mid-urethral sling: a retrospective cohort study comparing Safyre? and handmade sling

Purpose: This study examined and compared efficacy, safety, satisfaction, and complications of the retropubic Safyre (TM) sling and a retropubic hand-made synthetic sling (HMS) in a short-, mid- and long-term follow-up. Methods: We retrospectively reviewed a prospectively maintained database of women who underwent Safyre (TM) or HMS between March 7ths 2005 and December 27ths, 2017. Patients had first assessment (7-10 days), second (40-45 days), and third (sixth month) postoperatively. Between September and December 2018, patients who completed at least one year of surgery, received a telephone call. Follow-up compared quartiles of follow-up time to determine complications (Clavien-Dindo), success rates (International Consultation on Incontinence Modular Questionnaire for Urinary Incontinence Short Form - ICIQ-UI SF), and patient satisfaction. Results: Three hundred fifty-one patients underwent surgery and 221 (63%) were evaluated after a median of 78.47 (+/- 38.69) months, 125 (55%) in the HMS, and 96 (45%) in the Safyre (TM) group. Higher intraoperative bladder injury was observed with Safyre (TM) (0% vs. 4.2%, p=0.034), and a tendency for urinary retention, requiring indwelling urinary catheter over 24 hours (2.4% vs. 8.3%, p=0.061). Both HMS (p<0.001) and SafyreT (p<0.001) presented improvements on ICIQ-UI SF. There were no differences in satisfaction, subjective cure rates, ICIQ-UI SF, or complications between groups. Conclusions: Both HMS and Safyre (TM) have similar satisfaction and subjective cure rates, with marked ICIQ-UI SF score improvement. Higher rates of intraoperative bladder injury were seen in patients who received SafyreT retropubic sling.