Comparison of an adjustable anchored single‐incision mini‐sling, A just ® , with a standard mid‐urethral sling, TVT‐O TM : a health economic evaluation

Objectives To assess the cost, quality of life ( QoL ) and cost‐effectiveness of a single‐incision mini‐sling ( SIMS ; A just ® , C . R . B ard I nc., N ew P rovidence, NJ , USA ) compared with a standard mid‐urethral sling ( SMUS ; TVT ‐ O ™, E thicon I nc., S omerville, NJ , USA ) in the surgical management of female stress urinary incontinence.Patients and Methods A total of 137 women, in a secondary care setting, were randomized between O ctober 2009 and O ctober 2011 to undergo SIMS placement ( n = 69) under local anaesthesia as an opt‐out policy or SMUS placement ( n = 68) under general anaesthesia. Clinical outcome measures included the patient‐reported success rate (Patient Global Impression of Improvement [ PGI ‐ I ]) and the impact on the patients’ QoL ( K ing's H ealth Q uestionnaire [ KHQ ]). Health economic data (cost and quality‐adjusted life year [ QALY ] data) were compared using linear regression models to generate an incremental cost per QALY estimate, in order to determine a measure of cost‐effectiveness. Deterministic sensitivity analyses investigated uncertainty in the results, and non‐parametric bootstrapping techniques were used to estimate a probability of cost‐effectiveness.Results There were no significant differences between the groups in terms of the KHQ total score ( P = 0.27) or the patient‐reported success rate ( P = 1.00, odds ratio: 0.895; 95% confidence interval [ CI ]: 0.344 to 2.330). There was no significant difference in QALYs for the SIMS group compared with the SMUS group (mean difference: −0.003; 95% CI : −0.008 to +0.002). The SIMS was on average less costly, −£142.41 95% CI : (−316.99 to 32.17) and generated cost savings of £48 419 per QALY loss with 94% probability of cost savings to the health services. Taking a wider perspective on the costing analysis by including the wider community benefit associated with the significantly earlier return to work observed in the SIMS group ( P = 0.006, 95% CI : 11.756 to 17.217), there was an increase in cost savings to −£477, (95% CI : −823.65 to −129.63), with a probability of 100% of cost savings to the wider economy.Conclusions The adjustable anchored SIMS ( A just), performed under local anaesthesia as an opt‐out policy, delivers cost savings to the health service provider when compared with the SMUS ( TVT ‐ O ), and is likely to be cost‐effective up to 1 year after placement. Further research should be undertaken to confirm the results of our study over longer follow‐up and should explore patient preferences alongside an adequately powered non‐inferiority randomized controlled trial.