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

The University of Aberdeen requires access to NHS England data for the purpose of the following research project:

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

The following is a summary of the aims of the research project provided by the University of Aberdeen:

The FUTURE trial is required because overactive bladder (OAB) is a common problem 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 A (BoNT-A) or sacral neuromodulation (SNM), 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.

The primary objectives of the trial are to:

1. Evaluate whether routine urodynamics investigation and comprehensive clinical assessment significantly improves patient reported success rates following treatment, compared to comprehensive clinical assessment only.

2. Assess the cost-effectiveness of routine urodynamics investigation and comprehensive clinical assessment, compared to comprehensive clinical assessment only.

The following NHS England Data will be accessed:

• Hospital Episode Statistics

o Admitted Patient Care (APC) and Outpatients (OP) – necessary to identify any further admissions, reoperations and treatments for their bladder condition.

The level of the Data will be:

• Identifiable – necessary because although the data provided by NHS England will contain pseudonymised fields, the University of Aberdeen retain access to the corresponding identifiers. While no efforts will be made to reidentify participants, the technical capability to do so remains.

The Data will be minimised as follows:

• Limited to a study cohort identified by University of Aberdeen –

• 839 women who were recruited to the FUTURE trial from NHS Trusts in England and who consented to being contacted about the longer-term follow-up study and relevant information being collected from NHS central registers. Those recruited into the FUTURE trial met the following criteria:

- women aged ≥18 years with refractory overactive bladder (OAB) or urgency predominant Mixed Urinary Incontinence (I.e. in whom OAB are their most bothersome symptoms)

• Limited to data between November 2017 and July 2025 [to coincide with the data obtained from Public Health Scotland]

• For each individual participant, data will only be provided from the date they joined the trial [date to be provided by the University of Aberdeen ] until July 2025 [to coincide with the data obtained from Public Health Scotland]

The University of Aberdeen and NHS Grampian are the research co-sponsors. However, the University of Aberdeen is the sole controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

The funding is provided by the National Institute for Health Research (NIHR). The funding is specifically for the trial described. Funding is in place until January 2026.

The funder will have no ability to suppress or otherwise limit the publication of findings.

The University of Sheffield is a processor acting under the instructions of the University of Aberdeen. University of Sheffield’s role is limited to receiving a copy of the pseudonymised trial dataset using the secure ZendTo web-based service at the University of Aberdeen. This pseudonymised trial dataset will be accessed by trial health economists, based at the University of Sheffield.

The Project Management Group consists of the grant holders and representatives from the trial office team at the University of Aberdeen. The grant holders are based at different institutions across the UK (Sheffield Teaching hospital NHS Foundation Trust, University of Sheffield, North Bristol NHS Trust, NHS Greater Glasgow & Clyde, Manchester University NHS Foundation Trust, University of the West of England, University Hospital Southampton NHS Foundation Trust, Newcastle Upon Tyne Hospitals NHS Foundation Trust, University of Bristol, Bladder Health UK (registered charity) and University of Edinburgh). These institutions (other than the University of Sheffield) are neither a controller nor processor of the data under this Agreement. The grant holders will only have access to the aggregated data (with small numbers suppressed) following analysis and they are involved in dissemination of the results.

A Trial Steering Committee (consisting of four independent members, one of which is a patient and public representative) and a Data Monitoring Committee (consisting of three independent members whose primarily role is to oversee the safety of participants) will meet for the duration of the trial. These members are independent from the study team and their institutions. However, neither of these committees make any decisions regarding the data collected and will not have access to the NHS England data nor any participant level data. They will have access to only aggregated level data (with small number suppressed) following analysis and they will be involved in the interpretation of results.

The University of Aberdeen (Centre for Healthcare Randomised Trials (CHaRT), Institute of Applied Health Sciences) will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, name , Postcode, and a unique person ID) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the HES datasets to the University of Aberdeen. The Data will

• contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient

University of Aberdeen will extract a subset of the Data comprised of a pseudonymised NHS England data and securely transfer this to the University of Sheffield for the purposes of the health economic analyses.

The Data received from NHS England will be stored on servers at the University of Aberdeen only. However, a subset of the Data comprised of pseudonymised NHS England data will be shared with and stored at the University of Sheffield.

The Data will be accessed onsite at the premises of University of Aberdeen or will be accessed by authorised personnel via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for re

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

Remote processing will be from secure locations within the UK. The data will not leave the UK at any time.

Access to the data is restricted to employees of the University of Aberdeen and University of Sheffield who have authorisation from the Chief Investigator.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

Participants were recruited from across Scotland and England. Therefore, a similar application for routinely collected data from Public Health Scotland has been approved. Once the routinely collected data is received, limited variables will be incorporated into the FUTURE dataset, which already contains participant reported outcomes, prior to analysis.

The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

Researchers from the University of Aberdeen and the University of Sheffield will process the Data for the purposes described above.

The expected outputs of the processing will be:

• A report of findings to trial participants, published with assistance from Bladder Health UK and the PPI representative on the independent Trial Steering Committee.

• Submissions to peer reviewed journals using an open access format

• Presentations at appropriate national and international conferences.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Peer-reviewed journals

• National and International conferences

• Press/media engagement

• Reports aimed at participants, which will consist of a one-page summary of the results, which will be accessible on the trial website.

The timelines for the activities outlined above are from March 2026 to July 2026.

Urodynamics is a test that has been embedded into clinical practice without robust evidence of its clinical or cost-effectiveness. Robust evidence has already shown that urodynamics has no impact on participant-reported outcomes following conservative treatment of urinary incontinence and for those undergoing surgical treatment for symptoms of pure stress urinary incontinence. Therefore, NICE prioritised research to assess the clinical and cost-effectiveness of urodynamics in the treatment of refractory overactive bladder.

The findings of this research study are therefore expected to contribute to evidence-based decision-making for policymakers, local decision-makers such as doctors, and patients on whether routine urodynamic investigation improves the treatment outcomes in women with refractory overactive bladder and whether it is cost effective.

Urodynamics is a test that has been embedded into clinical practice without robust evidence of its clinical or cost-effectiveness. Robust evidence shows urodynamics to have no impact on participant-reported outcomes following conservative treatment of urinary incontinence and for those undergoing surgical treatment for symptoms of pure stress urinary incontinence (SUI). Accordingly, NICE has prioritised research to assess the clinical and cost-effectiveness of urodynamics in treatment of refractory OAB. The outcome of the FUTURE trial will inform patients, clinicians, and policy makers whether routine urodynamic investigation improves the treatment outcomes in women with refractory OAB and whether it is cost effective.

NICE recommends urodynamic investigation to confirm the diagnosis of detrusor overactivity (DO) in women with refractory overactive bladder (OAB) before proceeding to invasive treatment.

For clinicians, urodynamics is traditionally considered to inform the counselling of women on the chances of success of subsequent treatments. However, in women with refractory OAB, urodynamics fails to show evidence of DO in up to 45%. The accuracy of urodynamics relies on well calibrated equipment, experience of investigators and their objective interpretation of subjective parameters. Hence the standardisation of the test is difficult and is affected by the wide variation in staff practice and type of equipment used. These factors raise a valid debate on the clinical and cost-effectiveness of urodynamics and whether it improves the outcomes of subsequent treatments compared to treatment guided by comprehensive clinical assessment (CCA) only.

From the patients’ perspective, many describe urodynamics as invasive and embarrassing. Urodynamics is also associated with a risk of discomfort and urinary tract infections (UTIs). However, the majority of women find it acceptable if it will improve their outcomes post-treatment.

For policy makers, inevitably urodynamics is costly to the NHS, including purchase of equipment and disposables, and the need for specialist staff. The urodynamics tariff was £256/ patient at time of the trial design. Policy makers are faced with the current pressure on health resources in the UK; therefore, there is a pressing need to direct resources towards evidence-based interventions that are proven to positively improve treatment outcomes.

It is hoped that through publication of findings in peer-reviewed journals and dissemination of results at national/international conferences, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or pathway decisions in relation to specific patients with overactive bladder.

The team will work with the University of Aberdeen to deliver an effective programme of dissemination of research findings to key stakeholders (NHS commissioners, clinicians, funding bodies, service users/participants, charities and the general public) employing up-to-date innovative methods. The team will specifically engage with platforms relevant to women’s health and maximise opportunities to raise awareness among women and their families to the results of this study and what these might mean for them. This will be accompanied by a press release to maximise exposure to TV, radio, and newspapers, along with planned activity on social media to raise awareness among the general public nationally and internationally. The team will adopt individualised strategies for all stakeholders.

Yielded Benefits is not a requirement for new applications.