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%).