Abstract
Background. Evaluation of cost-effectiveness of new surgical techniques is important. As the data on incontinence procedures are scarce, we evaluated the cost-effectiveness of tension-free vaginal tape procedure and laparoscopic mesh colposuspension as a primary surgical treatment for female stress urinary incontinence. Methods. In four university teaching hospitals and two central hospitals 128 stress incontinent women were randomized to tension-free vaginal tape procedure (n=70) or laparoscopic mesh colposuspension (n=51) in order to investigate the clinical performance of these two procedures. Primary objective clinical outcome measures were: stress test and 48-h pad test. Secondary subjective outcome measures were health-related quality of life measured in terms of visual analogue scale and Urinary Incontinence Severity Score. Alongside the clinical trial, a cost-effectiveness analysis for the main outcome measures was performed. Results. The changes in the 48-h pad test result did not reach statistical significance (p=0.105). When the visual analogue scale or Urinary Incontinence Severity Score are used as the outcome measure, the tension-free vaginal tape is more cost-effective than laparoscopic mesh colposuspension over a follow-up period of one year (p<0.000). Conclusion. The clinical and economic data of the present study suggest that over a follow-up period of one year the tension-free vaginal tape procedure is more cost-effective than laparoscopic mesh colposuspension as a primary treatment for female stress urinary incontinence.