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 bladder symptoms

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

Abstract

Background: 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. Methods: 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. Discussion: 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. Trial registration: ISRCTN63268739. Registered on 14 September 2017.

• Journal Article Type: Article
• Acceptance Date: Sep 24, 2021
• Online Publication Date: Oct 26, 2021
• Publication Date: 2021-12
• Deposit Date: Dec 9, 2021
• Publicly Available Date: Dec 9, 2021
• Journal: Trials
• Print ISSN: 1745-6215
• Electronic ISSN: 1745-6215
• Publisher: BioMed Central
• Peer Reviewed: Peer Reviewed
• Volume: 22
• Issue: 1
• Article Number: 745
• DOI: https://doi.org/10.1186/s13063-021-05661-3
• Keywords: Pharmacology (medical); Medicine (miscellaneous); incontinence, female health, lower urinary tract symptoms
• Public URL: https://uwe-repository.worktribe.com/output/8045571
• Additional Information: Received: 6 November 2020; Accepted: 24 September 2021; First Online: 26 October 2021; : ; : The trial has ethical approval from the North of Scotland REC (17/NS/0018), and local NHS site R&D approvals have been obtained. Women must provide signed and dated written informed consent before undergoing any study-specific procedures. Verbal consent is obtained for the qualitative interviews.; : Not applicable as there are no identifying images or other personal or clinical details of participants presented. Informed consent materials are available from the corresponding author.; : Professor Abdel-fattah reports no competing interest for this study however he provides full and updated details of all potential competing interests for his research and clinical practice in general on his university staff page ExternalRef removedKaren Ward reports Topic expert: Urinary Incontinence and Pelvic Organ Prolapse NICE Guideline (NG123) 2016-2019, Vice Chair British Society of Urogynaecologists 2019-2021Ash Monga reports Consultant and paid speaker for Contura; Paid speaker Boston Scientific; Chair of the EUGA industry liaison committee; Advisory board Atlantic TherapeuticsAll other authors report no conflicts of interest.