Prospective analysis of complications of tension-free vaginal tape from The Netherlands Tension-free Vaginal Tape study.

OBJECTIVE: The intra- and postoperative anatomic complications, frequency, and influence of risk factors of the tension-free vaginal tape are described.

STUDY DESIGN: This was a prospective cohort study of 809 patients.

RESULTS: The total intraoperative complication rate was 6.2%. Previous prolapse surgery was a risk factor for complications (odds ratio, 2.86; 95% CI, 1.15-7.11). We found more intraoperative complications in patients with general anesthesia than with local analgesia with sedation (odds ratio, 4.14; 95% CI, 2.01-8.53). In teaching hospitals the postoperative complication frequency was higher than in non-teaching hospitals (odds ratio, 0.55; 95% CI, 0.35-0.85). The learning curve is short, and more postoperative complications were found in the second 10 patients who underwent operation by 1 surgeon (odds ratio, 1.94; 95% CI, 1.14- 3.29). Spinal analgesia gives fewer postoperative complications than local analgesia with sedation (odds ratio, 0.35; 95% CI, 0.13- 0.92).

CONCLUSION: Tension-free vaginal tape is a relative safe procedure; concomitant pelvic surgery can be performed safely. Several risk factors for complications were identified: menopausal state, previous prolapse surgery, mode of anesthesia, teaching hospital, and the second ten procedures of each surgeon.