Invasive urodynamic investigations in the management of women with refractory overactive bladder symptoms (FUTURE) in the UK: a multicentre, superiority, parallel, open-label, randomised controlled trial
- PMID: 40132616
- DOI: 10.1016/S0140-6736(24)01886-5
Invasive urodynamic investigations in the management of women with refractory overactive bladder symptoms (FUTURE) in the UK: a multicentre, superiority, parallel, open-label, randomised controlled trial
Abstract
Background: Overactive bladder is a common problem affecting women worldwide, with a negative effect on their social and professional lives. Before considering invasive treatments, guidelines recommend urodynamics to identify detrusor overactivity. However, the clinical-effectiveness and cost-effectiveness of urodynamics has never been robustly assessed in this cohort of women. We aimed to compare the clinical-effectiveness and cost-effectiveness of urodynamics plus comprehensive clinical assessment (CCA) versus CCA only in the management of women with refractory overactive bladder symptoms.
Methods: We did a multicentre, superiority, parallel, open-label, randomised controlled trial in 63 UK hospitals. Women aged 18 years or older with refractory overactive bladder or urgency predominant mixed urinary incontinence, with failed conservative management and being considered for invasive treatment, were randomly assigned (1:1) to urodynamics plus CCA versus CCA only. Assignment used an internet-based application with stratified random permuted blocks and site and baseline diagnosis as stratum. Primary outcome was participant-reported success at the last follow-up timepoint, measured by the Patient Global Impression of Improvement at 15 months after randomisation. Primary economic outcome was incremental cost per quality-adjusted life-year (QALY) gained modelled over the participants lifetime. Analysis was based on the intention-to-treat principle. This study is registered with ISRCTN registry (ISRCTN63268739).
Findings: Between Nov 6, 2017, and March 1, 2021, 1099 participants were randomly assigned to urodynamics plus CCA (n=550) or CCA only (n=549). At the final follow-up timepoint, participant-reported success rates of "very much improved" and "much improved" were not superior in the urodynamics plus CCA group (117 [23·6%] of 496) versus the CCA-only group (114 [22·7%] of 503; adjusted odds ratio 1·12 [95% CI 0·73-1·74]; p=0·60). Serious adverse events were low and similar between groups. Incremental cost-effectiveness ratio was £42 643 per QALY gained. The cost-effectiveness acceptability curve showed urodynamics had a 34% probability of being cost-effective at a willingness-to-pay threshold of £20 000 per QALY gained, which reduced further when extrapolated over the patient's lifetime.
Interpretation: In women with refractory overactive bladder or urgency predominant mixed urinary incontinence, the participant-reported success in the urodynamics plus CCA group was not superior to the CCA-only group, and urodynamics was not cost-effective at the £20 000 per QALY gained threshold.
Funding: UK National Institute for Health and Care Research Health Technology Assessment Programme.
Copyright © Crown Copyright © 2025 Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license.
Conflict of interest statement
Declaration of interests MA-F declares other financial or non-financial interests as a speaker, consultant, or surgical trainer for several industrial companies (Astellas, Ethicon, Bard, Pfizer, AMS, Coloplast, and B Braun) with travel expenses reimbursed, and on occasions received personal honorariums and sponsorship towards attending scientific conferences; a research grant from Coloplast managed by University of Aberdeen; a small number of supported trainees who attended pharmaceutical sponsored educational or leadership workshops or received assistance towards presenting their research work at scientific conferences; being a previous chair of the Scottish Pelvic Floor Network, which at the time received sponsorship by various industrial companies and fees to exhibit in annual meetings and surgical workshops; receiving travel sponsorship and occasional speaker fees from numerous national and international conferences and non-profit organisations when invited as guest speaker or expert surgeon; and in 2019, at request from NHS Grampian, attended two educational meetings for setting up sacral nerve stimulation service partially funded by Medtronic. CC declares receiving consulting fees from Coloplast, Ingenion, MUVON Therapeutics, Pierre Fabre, ProVerum, Takeda, and Urovant; support for attending meetings or travel from the European Association of Urology and King Faisal Specialist Hospital and Research Centre; patents planned, issued, or pending with the University of Sheffield; participation on a data safety monitoring board or advisory board for Coloplast, Ingenion, Pierre Fabre, and ProVerum; leadership or fiduciary role in other board, society, committee, or advocacy group as Past Secretary General of the European Association of Urology until March, 2023; and other financial or non-financial interest with Astellas as an author (non-financial). DC reports grants or contracts from the NIHR Health Technology Assessment funding for long-term follow-up of the MASTER and SIMS trials. HB-G declares grants or contracts from Merck Sharp & Dohme; and royalties or licences from the National Institute for Health and Care Excellence. KG declares payments for expert testimony as a Medicolegal advisor. NC declares participation on a data safety monitoring board or advisory board for the International Consultation on Incontinence Questionnaire Advisory Board; leadership or fiduciary role in other board, society, committee, or advocacy group for the Association for Continence Advice Executive Committee (unpaid) and Royal College of Nursing Bladder and Bowel Forum Steering Committee (unpaid). KW declares leadership or fiduciary role in other board, society, committee, or advocacy group as Chair of British Society of Urogynaecology (2021–23; unpaid), Vice Chair of British Society of Urogynaecology (2019–21; unpaid), and Topic Lead Urinary Incontinence – National Institute for Health and Care Excellence Guideline NG123: urinary incontinence and pelvic organ prolapse in women: management (2017–20; honorarium for attending meetings and travel). HH declares payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events for Medtronic, Laborie, and Allergan; leadership or fiduciary role in other board, society, committee, or advocacy group for European Association of Urology male lower urinary tract symptoms guidelines, Associate Editor British Journal of Urology International, and Associate Editor Neurourology & Urodynamics. AM declares payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events for Contura; payment for expert testimony for Kennedys Law; support for attending meetings and travel from Contura; leadership or fiduciary role in other board, society, committee, or advocacy group as chairman of industry liaison committee European Urogynaecological Association; and stock or stock options with Atlantic Medical and Viveca Biomed. MD declares grants or contracts from the Rosetrees Trust (chief investigator), NIHR Health Technology Assessment (project NIHR131984 and NIHR 131172, co-investigator) Medical Research Council (project MR/V033581/1, co-investigator), and Engineering and Physical Sciences Research Council (project EP/T020792/1, co-investigator); payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Astellas; payment for expert testimony for Astellas; and leadership or fiduciary role in other board, society, committee, or advocacy group for the International Continence Society Board of Trustees. AG declares royalties or licences from John Wiley & Sons; consulting fees from Laborie Medical Technologies, Invivo Bionics, and Flume Catheter Company; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Innologic. JN declares a leadership or fiduciary role in other board, society, committee, or advocacy group as Chair of the Medical Research Countil–NIHR Efficacy and Mechanism Evaluation Board (2019 to present). All authors declare a grant (reference number 15/150/05) from NIHR Health Technology Assessment was received by University of Aberdeen and Grampian Health Board to undertake the research.
Comment in
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Is there a FUTURE for urodynamic testing in refractory overactive bladder syndrome?Lancet. 2025 Mar 29;405(10484):1028-1029. doi: 10.1016/S0140-6736(25)00427-1. Epub 2025 Mar 22. Lancet. 2025. PMID: 40132617 No abstract available.
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