Risk Factors for Long-term Failure of the Retropubic Tension-Free Vaginal Tape Procedure

Abstract

The development of minimally invasive techniques to restore continence in women with stress urinary incontinence (SUI) led to the introduction of the retropubic tension-free vaginal tape (TVT) procedure in 1996. A number of studies have demonstrated promising long-term results after use of retropubic TVT. The largest long-term follow-up study to date was published in 2013 by the authors of the present study. Data from that study showed excellent long-term outcomes with low 10-year subjective and objective failure rates. The aim of this study was to identify potential risk factors of long-term (10-year) subjective and objective failure after the retropubic TVT procedure. A secondary risk analysis was performed merging 10-year outcome data from the 2013 study with additional preoperative and operative information individually stored in the Norwegian Female Incontinence Registry. Data were obtained on potential risk factors of subjective failure 10 years after TVT from 483 women with the use of a validated questionnaire. Data on potential risk factors of objective failure at 10 years were obtained from 327 women with the use of a standardized stress test. Logistic regression analyses were used to assess preoperative and operative data stored in the Norwegian Female Incontinence Registry. Subjective failure was defined as the percentage of women reporting that they were not cured. Objective failure was defined as urinary leakage of 1 g or greater during a standardized in-office stress test. The median time to follow-up was 129 months, and the median age at the time of surgery was 54 years (range, 26–87 years). Age of 56 years or older at the time of surgery was an independent risk factor of both long-term subjective (adjusted odds ratio [aOR], 2.15; 95% confidence interval [CI], 1.40–3.30) and objective failure (aOR, 2.81; 95% CI, 1.30–6.09). There was a significant risk for long-term subjective but not objective failure in women with mixed incontinence who had severe urinary incontinence symptoms; the aOR was 2.33, with a 95% CI of 1.27 to 4.28. In univariate analysis, surgical complications during or immediately after surgery were associated with both subjective and objective failure, but in multivariate analysis, surgical complications were an independent risk factor of only subjective failure (aOR, 3.02; 95% CI, 1.53–5.95). These data show that age of 56 years or older, severe preoperative urgency incontinence symptoms, and surgical complications are independent risk factors of long-term (10-year) failure after TVT surgery.