OBJECTIVES: To assess the cost, quality of life (QoL) and cost-effectiveness of Single Incision Mini Slings (SIMS-Ajust® ) compared to Standard Mid Urethral Slings (SMUS)- Tension-free Vaginal Tapes (TVT-OTM ) in surgical management of female stress urinary incontinence (SUI).
PATIENTS AND METHODS: 137 women were randomised between October 2009 and October 2011 in a secondary care setting, to undergo SIMS-Ajust® (n=69) under local anaesthesia (LA) as an opt-out policy or SMUS (TVT-OTM ; n=68) under general anaesthesia (GA) as originally described. Clinical outcome measures included Patient-reported success rate (Patient Global impression of improvement (PGI-I)) & impact on women's QoL (King's Health Questionnaire (KHQ)). Health economic data (Cost and Quality Adjusted Life Year (QALY) data) were compared using linear regression models to generate incremental cost per QALY estimate, to determine a measure of cost-effectiveness. Deterministic sensitivity analyses investigated any uncertainty in the results and non-parametric bootstrapping techniques were used to estimate a probability of cost-effectiveness.
RESULTS: There was no evidence of significant differences between both groups in the KHQ total score (p=0.27) or in the patient-reported success rate (p=1.00, Odds Ratio (OR): 0.895; 95% CI 0.344 to 2.330). SIMS-Ajust® generated no significant difference in Quality Adjusted Life Years (QALY); mean difference: -0.003; 95%CI: (-0.008 to 0.002) compared to SMUS- TVT-OTM . SIMS-Ajust® was on average £142.41 less costly, 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 and including the wider community benefit, associated with the significantly "earlier return to work" confirmed in the SIMS-Ajust® group (p=0.006, 95%CI: 11.756 to 17.217), the cost savings increased to -£477, (95% CI: -823.65 to -129.63), with a probability of 100% of cost savings to the wider economy.
CONCLUSIONS: Adjustable anchored SIMS-Ajust® performed under LA, as an opt-out policy, delivers cost savings to the health service provider when compared to SMUS TVT-OTM and is likely to be cost-effective up to one year follow-up. 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 randomised controlled trial.
Written by:
Boyers D, Kilonzo M, Mostafa A, Abdel-Fattah M. Are you the author?
University of Aberdeen.
Reference: BJU Int. 2013 Jul 25. Epub ahead of print.
doi: 10.1111/bju.12388
PubMed Abstract
PMID: 24053310
UroToday.com Stress Urinary Incontinence Section
