| Summary: | Until the late 1990s, the Burch colposuspension was considered the gold standard for the surgical treatment of stress urinary incontinence (SUI) and stress-dominated mixed urinary incontinence (MUI) in women. In 1996, Ulmsten introduced the minimally invasive retropubic tension-free vaginal tape (TVT) procedure, and the first case series reported high safety and effectiveness of this procedure at 2-year follow-up. Despite the lack of data showing the superiority of the new method, the TVT procedure replaced the Burch colposuspension as the preferred surgical method worldwide within a few years. We at the Department of Gynaecology at Nordland Hospital, Bodø, Norway, introduced the TVT procedure in 1998, and from 2000 onwards we stopped carrying out Burch colposuspensions completely. In order to confirm or reject the superiority of the new method, we applied data from surgeries performed before, during, and after this overlapping time period to compare the long-term treatment effectiveness of both surgical methods. In addition, we wanted to present short- and long-term safety and effectiveness data and to assess the risk factors for recurrence of SUI symptoms after the TVT procedure. Furthermore, the safety of the TVT procedure has been questioned, due to reports of serious and debilitating problems among women who underwent the procedure to treat urinary incontinence (UI). After the introduction of the TVT procedure, the number of women undergoing UI surgery increased rapidly, and the quality of this surgical treatment came into focus. We were particularly interested in the role of surgeon’s experience on clinical outcomes after TVT surgery. The study population comprised 748 primary incontinence surgeries performed at our department in the period 1994-2012. In the assessment of clinical outcomes in Paper I, we compared the last 5 years of the Burch colposuspension (n = 127, 1994-1999) with the first 5 years of the retropubic TVT procedure (n = 180, 1998-2002). In Paper II, we assessed long-term clinical outcomes (n = 596, 1998-2012) of the primary TVT procedure and performed an analysis of demographic, clinical, and perioperative risk factors for treatment failure. Paper III was an assessment of associations between surgeon’s experience with the primary retropubic TVT procedure and both perioperative complications and recurrence rates. The 3 papers were designed as patient series, and the statistical analyses were done using the Statistical Package for the Social Sciences, with a 5% level of statistical significance. We applied the t-test, Chi Square test, survival analysis, Cox regression analysis, and binary regression analysis. In Paper I, we found a significant, higher cumulative SUI symptom recurrence rate at 12-year follow-up in women who received the Burch colposuspension compared to those who received the TVT procedure, when pure SUI was used as the indication for surgery. However, we did not find any significant difference in treatment effectiveness among women who received this procedure for MUI. In Paper II, we found that the TVT procedure had a high long‐term durability, and that long-term complications were rare. Furthermore, we demonstrated that the TVT procedure was much more effective in women with SUI than MUI; the recurrence rate was two-fold higher among women with MUI. In Paper III, we observed that patients of surgeons who have less experience with the primary TVT procedure showed higher risk of bladder perforation and urinary retention, with less impact on long-term recurrence rates. We found significant differences in recurrence rates between surgeons, and the differences in recurrence rates between women with MUI and SUI were similar for the two surgeons who had performed TVT procedures throughout the study period.
|
|---|