Long-term results of two different trans-obturator techniques for surgical treatment of women with stress and mixed urinary incontinence: a 10-year randomised controlled study follow-up.

INTRODUCTION: Our aim was to compare the long-term results and complications of the outside-in (Monarc®) versus inside-out (TVT-O®) trans-obturator approaches.
METHODS: We performed a 10-year follow-up of our randomised study from 2007 in which we compared short-term outcomes of both procedures in 120 women. Patients were examined at our department in a tertiary centre between March and December 2016. The primary aim of the study was to compare the cure and satisfaction rates of both procedures. The secondary aim was to determine the incidence of vaginal tape exposures, dyspareunia and LUTS. Statistical analysis was performed using SPSS Statistics Programme 21.0. Descriptive statistics were calculated based on basic patient characteristics. Non-parametric tests were used for comparisons of numerical and Pearson's chi-square for categorical data. Statistical significance was set at p < 0.05.
RESULTS: Of 114 living patients, 82.5% responded. Average follow-up time was 10.2 years. There were no statistically significant differences between the objective (84.6% for Monarc vs. 94.6% for TVT-O) and subjective cure rates (67.9% vs. 68.3%) or satisfaction rates (83.9% vs. 78.7%). We found no cases of vaginal tape exposure; 6.4% of all (10.3% of sexually active) patients reported dyspareunia and 34% reported LUTS with no significant differences between groups. DISCUSSION: According to our study, both the inside-out and outside-in procedures showed comparable long-term efficacy with low complication rates. To our knowledge, this is the longest randomised study follow-up comparing the cure and satisfaction rates of these two techniques.

RCT Entities:   Population Interventions Outcomes