Strengths and Limitations
Our trial’s strength is the thorough standardization of surgical technique with all procedures implemented by the same experienced urogynecology surgeon. Furthermore, our trial employed a prospective randomized study design together with long term follow-up. Subsequent data analysis evaluated both objective and subjective outcomes via validated methods. However, one limitation might be that neither patients nor surgeons were blinded to the procedure performed.
Loss to follow-up rates reported in our trial was 21.4% in SIS group and 23.8% in TOT group. These rates were better or equivalent to previously published randomized trials with two or three years follow up time 20, 17. Within our four year observation interval, it was challenging for both patients and physicians to maintain commitment. The IUGA/ICS classification system was used to standardize complication rates. Tape exposure rates (1.5% in SIS and 3.1% in TOT groups) and lower urinary tracts symptoms including urine retention (3.0% in SIS and 4.6% in TOT groups) were in accordance with other reports 20,17, 18. Although not statistically significant, our mini sling surgeries were associated with slightly more revision procedures owing to SUI recurrence compared to TOT (7.6% vs. 6.3%).