Researchers conducted the FUTURE study, a randomized controlled trial, to evaluate the clinical and cost-effectiveness of invasive urodynamic investigations in the management of women with refractory idiopathic overactive bladder or urgency-predominant mixed urinary incontinence. The trial, led by Mohamed Abdel-Fattah, MD, of Aberdeen Centre for Women’s Health Research at the University of Aberdeen and funded by the UK National Institute for Health and Care Research, was conducted across 63 secondary and tertiary hospitals in the United Kingdom. Results were published in The Lancet and also presented at the European Association of Urology Congress 2025.
Study participants included 1,099 women aged 18 years or older with overactive bladder symptoms who had failed conservative treatments and were considering invasive options. Participants were randomly assigned in a 1:1 ratio to undergo either invasive urodynamics plus comprehensive clinical assessment (CCA; n = 550) or CCA alone (n = 549). The primary clinical outcome of the trial was participant-reported success on the Patient Global Impression of Improvement scale at the final follow-up, defined as “very much improved” or “much improved.” The primary economic outcome was the incremental cost per quality-adjusted life-year (QALY) gained, modeled over the participant’s lifetime.
At the final follow-up (≥15 months), 117 of 496 participants (23.6%) in the urodynamics plus CCA group reported treatment success compared with 114 of 503 (22.7%) in the CCA-only group (adjusted odds ratio [aOR] = 1.12; 95% confidence interval [CI] = 0.73–1.74; P = .60). Per-protocol analysis and sensitivity models yielded similar results. When using a less strict definition of success (including “improved”), success rates were 43.8% in the urodynamics plus CCA group vs 41.6% in the CCA-only group (aOR, =1.14; 95% CI = 0.79–1.65; P = 0.47). Adverse event rates were comparable between groups (20.6% in the urodynamics plus CCA group vs 22.2% in the CCA-only group).
The economic evaluation showed that urodynamics testing incurred higher costs, with an incremental cost-effectiveness ratio of £42,643 per QALY gained. The probability of cost-effectiveness at a £20,000/QALY threshold was 34%, which declined to 23% when extrapolated over a lifetime horizon.
Although urodynamics altered clinical diagnoses in 13% of cases,—primarily by identifying stress incontinence,—it did not result in superior patient-reported outcomes or a reduction inadverse events. The researchers concluded that the results of the study do not support routine use of urodynamics in this patient population.
Full disclosures can be found in the published study.