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Randomized Controlled Trial
. 2025 Jul;29(27):1-139.
doi: 10.3310/UKYW4923.

Invasive urodynamic investigations in the management of women with refractory overactive bladder symptoms: FUTURE, a superiority RCT and economic evaluation

Mohamed Abdel-Fattah  1 , Christopher Chapple  2 , Suzanne Breeman  1 , David Cooper  1 , Helen Bell-Gorrod  3 , Preksha Kuppanda  4 , Karen Guerrero  5 , Simon Dixon  3 , Nikki Cotterill  4 , Karen Ward  6 , Hashim Hashim  7 , Ash Monga  8 , Karen Brown  9 , Marcus Drake  7 , Andrew Gammie  10 , Alyaa Mostafa  1 , Rebecca Bruce  1 , Victoria Bell  1 , Christine Kennedy  1 , Suzanne Evans  11 , Graeme MacLennan  1 , John Norrie  12
Affiliations
Randomized Controlled Trial

Invasive urodynamic investigations in the management of women with refractory overactive bladder symptoms: FUTURE, a superiority RCT and economic evaluation

Mohamed Abdel-Fattah et al. Health Technol Assess. 2025 Jul.

Abstract

Background: Overactive bladder is a common problem affecting the United Kingdom adult female population. Symptoms include urinary urgency, with or without urgency incontinence, increased daytime urinary frequency and nocturia. Initial conservative treatments for overactive bladder are unsuccessful in 25-40% of women (refractory overactive bladder). Before considering invasive treatments, such as botulinum toxin injection-A or sacral neuromodulation, guidelines recommend urodynamics to confirm diagnosis of detrusor overactivity. However, the clinical and cost effectiveness of urodynamics has never been robustly assessed.

Objectives: To compare the clinical and cost effectiveness of urodynamics plus comprehensive clinical assessment versus comprehensive clinical assessment only in the management of refractory overactive bladder in women.

Design: Parallel-group, multicentre, superiority, open-label, randomised controlled trial. Allocation by remote web-based randomisation (1 : 1 ratio). The cost-effectiveness analysis took the National Health Service perspective with a model-based lifetime time horizon, as informed by a within-trial analysis.

Setting: Sixty-three United Kingdom secondary and tertiary hospitals.

Participants: Women aged ≥ 18 years with refractory overactive bladder or urgency-predominant mixed urinary incontinence who had failed conservative management and pharmacological treatment and were being considered for invasive treatment. Women were excluded if any of the following criteria were met: predominant stress urinary incontinence; previous urodynamics in last 12 months; current pelvic malignancy or clinically significant pelvic mass; bladder pain syndrome; neurogenic bladder; urogenital fistulae; previous treatment with botulinum toxin injection-A or sacral neuromodulation for urinary incontinence; previous pelvic radiotherapy; prolapse beyond introitus; pregnant or planning pregnancy; recurrent urinary tract infection where a significant pathology has not been excluded; and inability to give an informed consent.

Interventions: Urodynamics plus comprehensive clinical assessment (urodynamics arm) versus comprehensive clinical assessment only.

Main outcome measures: Participant-reported success at the last follow-up time point as measured by the Patient Global Impression of Improvement. Primary economic outcome was incremental cost per quality-adjusted life-year gained as modelled over the lifetime of participants.

Results: A total of 1099 participants were included: 550 randomised to the urodynamics arm and 549 to the comprehensive clinical assessment only arm. At the final follow-up time point, participant-reported success rates of 'very much improved' and 'much improved' were not superior in the urodynamics arm (117 participants; 23.6%) compared to the comprehensive clinical assessment only arm (114 participants; 22.7%) [adjusted odds ratio 1.12 (95% confidence interval 0.73 to 1.74); p = 0.601]. Serious adverse events were low and similar between groups. Based on the estimated incremental costs and quality-adjusted life-years of urodynamics (£463 and 0.011, respectively), the incremental cost-effectiveness ratio was £42,643 per quality-adjusted life-year gained. The cost-effectiveness acceptability curve shows that urodynamics has a 34% probability of being cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained. This probability reduced further when the results were extrapolated over the patient's lifetime. Limitations include: only short-term outcomes were available, and as most participants underwent botulinum toxin injection-A treatment, pre-planned secondary analyses for some outcomes such as sacral neuromodulation were not possible.

Conclusion: Participant-reported success in the urodynamics arm was not superior to the comprehensive clinical assessment only arm at 15-months follow-up. Urodynamics is not cost-effective at a threshold of £20,000 per quality-adjusted life-year gained. Longer-term follow-up is required to explore need for further interventions and treatments and their effect on the clinical and cost-effectiveness analyses.

Trial registration: This trial is registered as ISRCTN63268739.

Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 15/150/05) and is published in full in Health Technology Assessment Vol. 29, No. 27. See the NIHR Funding and Awards website for further award information.

Keywords: RANDOMISED CONTROLLED TRIAL; REFRACTORY OVERACTIVE BLADDER; URODYNAMICS; WOMEN.

Plain language summary

Overactive bladder affects 12–14% of United Kingdom women. Initial treatments include lifestyle changes, pelvic floor exercises, bladder training and tablets. Sometimes these treatments do not work, with many women requiring more invasive procedures. Before having these procedures, it is normal United Kingdom practice to have an invasive test called urodynamics. Some women find urodynamics embarrassing and/or uncomfortable. After the test, some get cystitis (a urine infection) and in about one-third of women urodynamics does not show the cause of their overactive bladder symptoms. This may result in some women not being offered treatments which may help their condition. In this study, 1099 women who were looking for invasive treatments agreed to take part. They were randomly allocated to receive urodynamics plus a clinical assessment (550 women) or a clinical assessment only (549 women). The clinical assessment included a detailed medical history, clinical examination, bladder diary and non-invasive tests. We compared the two groups by asking the women about their symptoms throughout the study. Slightly fewer women in the urodynamics group received treatment during the study. Of those who did receive treatment, an injection of Botox into the bladder wall was the most common treatment in both groups. There was no difference in complications between the groups. At the end of the study, women in both groups reported an improvement in their quality of life. The number of women who said their symptoms were ‘very much improved’ or ‘much improved’ was similar between the groups [117 women (23.6%) in the urodynamics group compared with 114 women (22.7%) in the clinical assessment only group]. The additional cost to the National Health Service in receiving urodynamics was £463. The views of the women interviewed during the study varied, with some saying they were willing to have urodynamics if it helped with treatment decisions, while others were extremely worried about the discomfort and embarrassment of the procedure. This study suggests that performing urodynamics before invasive treatment does not lead to an improvement in women’s overactive bladder symptoms compared to comprehensive clinical assessment only (i.e. is not superior) and is more expensive. However, further work is under way to confirm this in the longer term.

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