TVT SECUR System: Final results of a prospective, observational, multicentric study.

Introduction and Hypothesis: This is an observational multicentre prospective study into the complications and effectiveness of TVT SECUR™.
Methods: One hundred forty-seven patients with urodynamic or occult Stress Urinary Incontinence (SUI) were enrolled. Outcome measures at 6, 12 and 24 months were: objective cough test; subjective responses to PGI-S questionnaire and Visual Analogue Score.
Statistical Analysis: Wilcoxon Test; Monte Carlo Exact Test.
Results: Ninety-five urodynamic SUI and 41 occult SUI patients were treated using transobturator (H-position) or retropubic (U-position) approach (110 vs. 26 patients). Cure rates at 6, 12, and 24 months were 87.5%, 88.6% and 89.5%. Failure rates at all follow-ups were similar for urodynamic and occult SUI. The U-position failure rate was comparable to H-position at short-term but significantly higher at mid-term. Familiarity with the technique brought significantly higher success rates.
Conclusions: TVT SECUR is safe, effective and versatile, but has an appreciable learning curve.