Objective: To conduct an economic evaluation of the use of trans-obturator tape (TOT) compared with tension-free vaginal tape (TVT) in the surgical treatment of stress urinary incontinence (SUI) in women.
Design: Cost utility analysis from public-payer perspective, conducted alongside a randomised clinical trial (RCT).
Setting: Health services provided in Alberta, Canada.
Population: A total of 194 women who participated in the RCT, followed to 1 year from surgery.
Methods: Data collected on all women in the RCT, over 12 months following surgery. Comparisons undertaken between RCT groups for cost and quality-adjusted life-years (QALYs). Multiple imputation used for the 10% missing data. Bootstrapping used to account for sampling uncertainty. One-way sensitivity analysis conducted for productivity loss due to time away from work.
Main outcome measures: Utility--15D questionnaire was used to calculate QALYs. Costs over 12 months--from trial data, health provider and provincial ministry of health.
Results: The TOT group had a non-significant average saving of $1133 (95% CI -2793; 442), with no difference in average QALYs between groups (95% CI -0.02; 0.01). TOT was cost-saving in over 80% of bootstrapping replications, over a wide range of willingness-to-pay.
Conclusion: The bootstrapping replication results suggest that TOT could be cost-effective compared with TVT in the treatment of SUI. However, these results must be confirmed by longer-term assessment of clinical and economic outcomes, because of concern that surgical tape palpable at 12 months may lead to vaginal erosion and further treatment.
Trial registration: ClinicalTrials.gov NCT00234754.
© 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG.