Authors' objectives: 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. 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. Overactive bladder (OAB) affects 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 well-being. 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 A (BoNT-A) or sacral neuromodulation (SNM), 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 timely need to evaluate its clinical and cost effectiveness. To compare the clinical and cost-effectiveness of urodynamics plus comprehensive clinical assessment (CCA) versus CCA only in the management of refractory OAB symptoms in women.

Authors' results and conclusions: 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. 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. Recruitment Between November 2017 and January 2021, 3066 potentially eligible participants were screened, 1511 (49.3%) confirmed eligible and 1103 (73.0%) gave their consent and were randomised. There was a pause in recruitment between March 2020 and August 2020 due to the COVID-19 pandemic. Following randomisation, four participants were considered ineligible and recorded as post-randomisation exclusions. Therefore, 1099 participants (550 in the urodynamics arm and 549 in the CCA only arm) were included in the trial. In participants with refractory OAB or urgency-predominant MUI, the participant-reported success rates following treatments in participants who undergo urodynamics and CCA are not superior to those who undergo CCA only up to 15-months follow-up. Significantly more women who undergo CCA only report earlier improvement in their symptoms. Urodynamics plus CCA is not cost-effective at a threshold of £20,000 per QALY gained.

Authors' methods: 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. Sixty-three United Kingdom secondary and tertiary hospitals. 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. Urodynamics plus comprehensive clinical assessment (urodynamics arm) versus comprehensive clinical assessment only. 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. Female Urgency, Trial of Urodynamics as Routine Evaluations (FUTURE) was a parallel-group, multicentre, superiority, randomised controlled trial. The cost-effectiveness analysis took the NHS perspective with a model-based lifetime time horizon, as informed by a within-trial analysis. FUTURE involved 63 secondary and tertiary hospitals across the UK. Women aged 18 years and over with refractory OAB or urgency-predominant mixed urinary incontinence (MUI), who had failed conservative management and pharmacological treatment and were being considered for invasive treatment, were invited to participate. Women were excluded if any of the following criteria were met: predominant stress urinary incontinence (SUI); previous urodynamics in last 12 months; current pelvic malignancy or clinically significant pelvic mass; bladder pain syndrome; neurogenic bladder; urogenital fistulae; previous treatment with BoNT-A or SNM for urinary incontinence; previous pelvic radiotherapy; prolapse beyond introitus; pregnant or planning pregnancy; recurrent urinary tract infection where a significant pathology had not been excluded; and inability to give an informed consent. Eligible and consenting participants were randomised to one of the following two treatment arms in a 1 : 1 allocation ratio using a remote web-based randomisation service: urodynamics plus CCA (urodynamics arm) CCA only (CCA only arm). The randomisation process used stratified random permuted blocks with (1) site and (2) diagnosis of OAB versus urgency-predominant MUI used as strata. The primary clinical outcome measure was participant-reported success at their last follow-up time point (either 15 or 24 months post randomisation) as measured by the Patient Global Impression of Improvement (PGI-I). Success was defined as participant response of ‘very much improved’ or ‘much improved’. The primary economic outcome was incremental cost per quality-adjusted life-year (QALY) gained. Secondary outcome measures included: a less strict definition of success at the last follow-up time point where success was defined as ‘very much improved’, ‘much improved’ or ‘improved’; proportion of women receiving invasive treatment during follow-up; participant-reported success in the first 2 months following BoNT-A (for women who received BoNT-A only); OAB symptoms measured by the International Consultation on Incontinence Questionnaire (ICIQ) overactive bladder (ICIQ-OAB) and the Urgency Perception Scale (UPS); urgency and urgency urinary incontinence episodes measured using the 3-day bladder diary; other urinary symptoms measured using the three domains of ICIQ female lower urinary tract symptoms (ICIQ-FLUTS; filling, voiding and incontinence) and the bladder diary; general health-related quality of life (HRQoL) status measured using generic [EuroQol-5 Dimensions, five-level version (EQ-5D-5L)] and condition-specific [ICIQ-LUTSQoL (ICIQ lower urinary tract symptoms quality of life)] assessment tools; adverse events; cost; and cost-effectiveness. Data collection during follow-up Participant-reported outcomes were assessed by self-completed questionnaire at baseline and 3, 6 and 15 months post randomisation. An additional 24-month post-randomisation questionnaire was completed by participants whose treatment had been delayed by the COVID-19 pandemic. A self-completed 3-day bladder diary was also collected at baseline and 6 and 15 months post-randomisation.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/15/150/05

Year Published: 2025

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/UKYW4923

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/UKYW4923

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk