Tension-free vaginal tape and laparoscopic mesh colposuspension in the treatment of stress urinary incontinence: immediate outcome and complications--a randomized clinical trial.

BACKGROUND The purpose of the study was to evaluate the immediate outcome and complications of the tension-free vaginal tape (TVT) and laparoscopic mesh colposuspension (LC) procedures in the treatment of female stress urinary incontinence (SUI). METHODS One hundred and twenty-eight patients suffering from urodynamically confirmed SUI were recruited to this multicenter, randomized clinical trial. After randomization there were seven drop-outs--121 patients were operated upon: 70 patients in the TVT group and 51 in the LC group. The patients were evaluated according to the study protocol before operation and 6 weeks after it. The independent sample t-test and the Mann-Whitney U-test were used to calculate statistical differences between the study groups. RESULTS Immediate cure rates, defined as negative stress test with 300 mL saline in the bladder, were similar (92.9% in the TVT group and 88.2% in the LC group; p = ns). Return to normal voiding was faster in the TVT group (9.2 h in the TVT group vs. 24.4 h in the LC group; p = 0.004). Fewer analgesics were used in the TVT group and hospital stay was shorter in this group. Complication rates associated with the procedures were similar and the number of complications was small. CONCLUSIONS The immediate outcome of both procedures is the same. The rates of complications were similar. However, the TVT procedure seems to be less invasive and requires fewer hospital resources than LC.