Female Urgency, Trial of Urodynamics as Routine Evaluation (FUTURE study): a superiority randomised clinical trial to evaluate the effectiveness and cost-effectiveness of invasive urodynamic investigations in management of women with refractory overactive

Overactive bladder (OAB) syndrome is a symptom complex affecting 12-14% of the UK adult female population. Symptoms include urinary urgency, with or without urgency incontinence, increased daytime urinary frequency and nocturia. OAB has a negative impact on women's social, physical, and psychological wellbeing. Initial treatment includes lifestyle modifications, bladder retraining, pelvic floor exercises and pharmacological therapy. However, these measures are unsuccessful in 25-40% of women (refractory OAB). Before considering invasive treatments, such as Botulinum toxin injection or sacral neuromodulation, most guidelines recommend urodynamics to confirm diagnosis of detrusor overactivity (DO). However, urodynamics may fail to show evidence of DO in up to 45% of cases, hence the need to evaluate its effectiveness and cost-effectiveness. FUTURE (Female Urgency, Trial of Urodynamics as Routine Evaluation) aims to test the hypothesis that, in women with refractory OAB, urodynamics and comprehensive clinical assessment is associated with superior patient-reported outcomes following treatment and is more cost-effective, compared to comprehensive clinical assessment only.

FUTURE is a pragmatic, multi-centre, superiority randomised controlled trial. Women aged ≥ 18 years with refractory OAB or urgency predominant mixed urinary incontinence, and who have failed/not tolerated conservative and medical treatment, are considered for trial entry. We aim to recruit 1096 women from approximately 60 secondary/tertiary care hospitals across the UK. All consenting women will complete questionnaires at baseline, 3 months, 6 months and 15 months post-randomisation. The primary outcome is participant-reported success at 15 months post-randomisation measured using the Patient Global Impression of Improvement. The primary economic outcome is incremental cost per quality-adjusted life year gained at 15 months. The secondary outcomes include adverse events, impact on other urinary symptoms and health-related quality of life. Qualitative interviews with participants and clinicians and a health economic evaluation will also be conducted. The statistical analysis of the primary outcome will be by intention-to-treat. Results will be presented as estimates and 95% CIs.

The FUTURE study will inform patients, clinicians and policy makers whether routine urodynamics improves treatment outcomes in women with refractory OAB and whether it is cost-effective.

ISRCTN63268739 . Registered on 14 September 2017.

Trials. 2021 Oct 26*** epublish ***

M Abdel-Fattah, C Chapple, K Guerrero, S Dixon, N Cotterill, K Ward, H Hashim, A Monga, K Brown, M J Drake, A Gammie, A Mostafa, U K Bladder Health, S Breeman, D Cooper, G MacLennan, J Norrie

Aberdeen Centre for Women's Health Research, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK. ., Department of Urology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK., Department of Urogynaecology, NHS Greater Glasgow and Clyde, Glasgow, UK., Health Economics and Decision Science, University of Sheffield, Sheffield, UK., Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK., Warrell Unit, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK., Department of Gynaecology, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Department of Gynaecology, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK., Aberdeen Centre for Women's Health Research, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK., Bladder Health UK, Registered charity, Birmingham, UK., Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK., Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.

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