Bell-Gorrod Helen, Thokala Praveen, Breeman Suzanne, Cooper David, MacLennan Graeme, Abdel-Fattah Mohamed, Dixon Simon
School of Medicine and Population Health, University of Sheffield, Sheffield, UK.
Health Services research Unit, University of Aberdeen, Aberdeen, UK.
BJU Int. 2025 Jul;136(1):82-94. doi: 10.1111/bju.16703. Epub 2025 Apr 19.
To estimate the cost-effectiveness of using invasive urodynamic studies (UDS) in the management of women with refractory overactive bladder (OAB) symptoms using the results of the FUTURE trial.
The FUTURE study is the largest randomised controlled trial evaluating the clinical effectiveness of UDS with comprehensive clinical assessment (CCA) in this patient population compared to CCA only. We developed an economic model that replicates the 24-month results of FUTURE, then models the lifetime costs and quality-adjusted life-years (QALYs) using long-term studies of treatment outcomes.
Over the patient cohort's lifetime the UDS plus CCA group is £1380 more costly and is associated with 0.002 fewer QALYs than the CCA only group, with only a 23.4% chance of being cost-effective at £20 000 per QALY gained. The sensitivity analysis shows that the results are robust to all changes except for the use of parameters based on the complete case analysis of the FUTURE trial. For the subgroup of patients with an initial diagnosis of mixed urinary incontinence, the UDS group gains more QALYs than the CCA group, albeit at a higher cost. The incremental cost-effectiveness ratio for UDS is £26 462, with a probability of being cost-effective of 45.3% at £20 000 per QALY gained and 53.8% at £30 000 per QALY gained.
The use of UDS in women with a diagnosis of OAB and whose condition is refractory to initial medical and conservative treatments is unlikely to be cost-effective when examined from a UK perspective and with a lifetime horizon. Despite having access to the FUTURE study data, the parameterisation of the model is limited by the current evidence base. An ongoing long-term follow-up study will help reduce these uncertainties.
利用FUTURE试验的结果,评估侵入性尿动力学研究(UDS)用于治疗难治性膀胱过度活动症(OAB)女性患者的成本效益。
FUTURE研究是评估UDS联合全面临床评估(CCA)与单纯CCA相比,在该患者群体中的临床有效性的最大规模随机对照试验。我们建立了一个经济模型来复制FUTURE试验的24个月结果,然后利用治疗结局的长期研究对终生成本和质量调整生命年(QALY)进行建模。
在患者队列的终生期间,UDS联合CCA组比单纯CCA组成本高1380英镑,且QALY少0.002个,每获得一个QALY以20000英镑计,具有成本效益的可能性仅为23.4%。敏感性分析表明,除了使用基于FUTURE试验完全病例分析的参数外,所有变化的结果都是稳健的。对于初始诊断为混合性尿失禁的患者亚组,UDS组获得的QALY比CCA组多,尽管成本更高。UDS的增量成本效益比为26462英镑,每获得一个QALY以20000英镑计,具有成本效益的概率为45.3%,以30000英镑计则为53.8%。
从英国的角度和终生视角来看,对于诊断为OAB且对初始药物和保守治疗无效的女性患者,使用UDS不太可能具有成本效益。尽管可以获取FUTURE研究数据,但模型的参数化受到当前证据基础的限制。正在进行的长期随访研究将有助于减少这些不确定性。