Objective: To assess the cost effectiveness of tension-free vaginal tape compared with open Burch colposuspension as a primary treatment for urodynamic stress incontinence.
Design: Cost-utility analysis alongside a multicentre randomised comparative trial.
Setting: Gynaecology or Urology departments in 14 centres in the UK and Ireland, including University-associated teaching hospitals and district general hospitals.
Population: Women with urodynamic stress incontinence. Exclusion criteria were: (1) detrusor overactivity; (2) major voiding problems; (3) prolapse; (4) previous surgery for incontinence or prolapse.
Methods: Resource use data were collected on all 344 patients in the trial, including length of hospital stay, time in theatre and management of complications; resource use was costed using UK unit costs at 1999-2000 prices.
Main outcome measures: Health outcomes were expressed in terms of quality-adjusted life years (QALYs) between baseline and six months follow up, based on women's responses to the EQ-5D health questionnaire.
Results: Tension-free vaginal tape resulted in a mean cost saving of pound 243 (95% CI pound 341 to pound 201) compared with colposuspension. Differential mean QALYs per patient (tension-free vaginal tape - colposuspension) was 0.01 (95% CI -0.01 to 0.03). The probability of tension-free vaginal tape being, on average, less costly than colposuspension, was 100%, and the probability of tension-free vaginal tape being more cost effective than colposuspension was 94.6% if the decision-maker was willing to pay pound 30,000 per additional QALY.
Conclusions: The results from this trial suggest that, over a post-operative period of six months, tension-free vaginal tape is a cost effective alternative to colposuspension. The results will need to be reassessed on the basis of longer follow up.