Purpose: To evaluate the mid-term efficacy and safety of the TVT-Secur device in the treatment of stress urinary incontinence.
Study design: Retrospective study evaluating 68 women affected by stress urinary incontinence treated with TVT-Secur procedure with hammock approach who attended the 24-month follow-up visit. Stress test, urodynamics, patient functional and quality of life questionnaires, visual analog scale pain score, and post-operative complications were evaluated. Data distribution was evaluated using the Shapiro-Wilk's test. Data were analyzed by the Student's t test for parametric variables, the Wilcoxon test for non-parametric variables, and the Chi-squared test for categorized variables.
Results: Objective cure rate 24 months after surgery was 80.8 %. Incontinence-quality of life and patient global impression of severity scores showed significant improvement. The only intra-operative complications were a vaginal wall tear and a case of severe bleeding, while post-operative complications were de novo urgency in five cases (7.3 %), one acute urinary retention (1.4 %), and one tape exposure (1.4 %). The study is limited by the retrospective design and the heterogeneity of patients.
Conclusions: TVT-Secur seems to be an effective and safe procedure for stress urinary incontinence.