Abstract
INTRODUCTION AND HYPOTHESIS: The objective was to determine if mid-urethral sling (MUS) tensioning with a Mayo Scissor as a sub-urethral spacer compared with a Babcock clamp holding a loop of tape under the urethra results in differences in patient-reported outcomes and rates of repeat surgery over a 5-year follow-up. METHODS: Follow-up 5 years after a randomized clinical trial, utilizing primary data collection linked to administrative health data, was carried out to create a longitudinal cohort. The primary outcome was participant-reported bothersome SUI symptoms, as defined by the Urogenital Distress Inventory (UDI-6) questionnaire. Secondary outcomes included participant-reported bothersome overactive bladder (OAB) scores, median scores of three validated urinary symptom questionnaires, and rates of subsequent surgery determined through patient report and administrative data. RESULTS: Two hundred and sixty (81.8%) of the original study participants provided participant-reported data at 5 years. Administrative data linkage was completed for all of the original participants (n = 318). Demographic characteristics remained similar in the two groups at the 5-year follow-up mark. No differences existed in the primary outcome of reported bothersome SUI symptoms (30.8% Scissors vs 26.8% Babcock, p = 0.559), proportion of participants with bothersome OAB, the median scores of three validated bladder questionnaires, or in rates and cumulative incidence of recurrent MUS surgery or surgical revision of mesh-related complications. CONCLUSION: Both the Scissor and Babcock tensioning techniques provided comparable outcomes at 5 years post-MUS surgery. The information from this study allows surgeons to better decide which technique to adopt in their practice, providing confidence in longer-term cure and safety.