The NIHR Health Technology Assessment (HTA) Programme is looking to fund research about interventions for improving outcomes in adults with faecal incontinence / Faecal Incontinence Research.
This is a 2-stage, commissioned funding opportunity. To apply for the first stage you should submit an outline application. If invited to the second stage, you will then need to complete a full application.
Introduction
Our Health Technology Assessment programme invites applications in response to specific research questions and priorities. These have been identified, developed and prioritised for their importance to stakeholders including:
- Department of Health and Social Care
- NHS
- patients and public
- local government
Research question
Our HTA Programme is interested in receiving applications for studies that evaluate the clinical and cost-effectiveness of interventions designed to improve the clinical outcomes of adults with faecal incontinence.
Background
The areas related to faecal incontinence outlined below represent avenues of investigation that may be relevant to this funding opportunity. However, this is not an exhaustive list – applications focused on the evaluation of interventions for faecal incontinence in any relevant area are welcome, provided the research is justified and is within remit for the HTA Programme. Similarly, applications focused on one of the areas listed below would not automatically be within remit for the HTA Programme.
Outpatient interventions, including but not limited to:
- transanal irrigation
- operant conditioning, for example biofeedback
- pelvic floor muscle therapy, including adjuncts to physiotherapy
- measures to address constipation and/or loose stool
- non-invasive neuromodulation
- polypharmacy and medication management.
More invasive procedures, including but not limited to:
- percutaneous or implanted neuromodulation
- surgical procedures addressing dynamic structural abnormalities, for example, repair of rectovaginal prolapse or intussusception.
Where feasible within a comparative effectiveness study, the HTA Programme is interested in investigating the impact of age and gender on faecal incontinence, as well as additional non-obstetric risk factors specific to females.
Applicants must specify and justify all aspects of their proposed study and research question, including the target population, intervention(s), comparator(s), outcomes, and study design.
Study design
Applicants may choose any robust study design, considered and justified, as the most appropriate method to evaluate the clinical and cost-effectiveness of interventions for adults with faecal incontinence.
Applicants should clearly define and justify all aspects of their proposed study, including their choice of patient group, hospital or community setting, intervention(s), comparator(s), study design, and outcome measures.
Faecal incontinence can be a challenging area in which to undertake research. Applicants should describe the challenges they anticipate encountering in conducting their proposed study, and how these will be addressed and mitigated.
Applicants should pay particular attention to the inclusion of under-represented and seldom-heard groups, for example those with learning disabilities, mental health issues, neurodivergence, and ethnic minority groups.
Outcomes of interest for this funding opportunity might include (but are not limited to):
- condition-specific symptoms and morbidity, such as severity and/or frequency of incontinence episodes
- quality of life and independence
- impact on daily life, including employment
- accuracy and timeliness of diagnosis
- patient and healthcare professional satisfaction and acceptability
- resource utilisation and cost-effectiveness.
Applications against this funding opportunity may include an element of evidence synthesis but stand-alone evidence synthesis, meta-analyses or value of information studies are not part of the HTA remit. For standalone studies the Evidence Synthesis Programme may be more suitable.
Feasibility studies will be considered in response to this funding opportunity. ‘Feasibility study’ refers to a standalone external pilot study that seeks to establish whether it is feasible to conduct a subsequent full-scale effectiveness study. The feasibility study would assess whether, for example, it is possible to randomise participants or whether the intervention is acceptable to patients. A feasibility study should not be proposed with the intention of establishing a signal of efficacy for the intervention.
Rationale
Faecal incontinence represents a significant health issue that warrants further research with the aim of improving the lives of those impacted. Recent data indicates a pooled prevalence of 9.1% in women and 7.4% in men, with UK estimates (NICE CKS) ranging from 8% to 12% in the general population, and higher figures (up to 60%) in residential care. Despite these statistics, the true burden likely remains significantly higher than figures suggest; faecal incontinence is characterised as a ‘silent affliction’ where deep-seated stigma frequently prevents patients from disclosing symptoms, resulting in under-reporting and delayed intervention.
Recent research demonstrates a shift in understanding regarding the epidemiology of faecal incontinence. While obstetric injury remains a key risk factor, it is now recognised that the condition is more evenly distributed across the sexes and driven by a broader range of variables, including age, stool consistency and the co-existence of constipation. Faecal incontinence frequently occurs alongside comorbidities such as inflammatory bowel disease, diabetes, and pelvic floor disorders, and current management pathways may not fully address the diverse needs of the patient population and this complexity. The impact of faecal incontinence on quality of life and societal participation, including social isolation and work absenteeism, are profound.
Our programme is interested in funding comparative effectiveness research into interventions for faecal incontinence, with primary outcomes that are health or social care-related and patient-centred – with findings that would be immediately useful to practice and improve management approaches.
Funding opportunity scope
This is a broad funding opportunity where our intention is to fund more than 1 study.
We recognise the importance of strengthening and expanding the evidence base that informs interventions to improve outcomes for adults with faecal incontinence, and we welcome studies that will advance understanding in this field. Research proposed should aim to address questions of clinical and cost-effectiveness, with findings that are likely to have a significant impact on patient care and influence clinical practice. We particularly welcome ambitious studies from multidisciplinary applicant teams and are open to innovative and adaptive study designs.
For some potential topics in this field there may be research questions related to how services are delivered or organised – however these would not be within remit of the HTA Programme. We are not looking for studies that seek to address issues of service delivery or implementation (for example, studies addressing provision of, or access to, incontinence pads) – such questions might be better suited to other funding sources (more information in out of scope section below). This funding opportunity seeks to answer questions of clinical and cost effectiveness.
In keeping with the remit of the HTA Programme, applications must have a focus on evaluating interventions that are ready for HTA evaluation. This means interventions:
- that are commonly used but for which evidence of effectiveness is lacking, or,
- for which there is an existing signal of efficacy, but where a pragmatic effectiveness study is needed
The following web pages may be helpful for researchers who are considering an application to this funding opportunity:
Studies investigating the efficacy (rather than the effectiveness) of interventions, and mechanistic studies, might lie within the remit of the NIHR/MRC Efficacy and Mechanism Evaluation (EME) Programme. The EME Programme also has an interest in faecal incontinence and applications that fall into EME remit should be submitted to the EME researcher-led workstream.
Examples of recent HTA studies that would be considered in scope for this funding opportunity include:
- A randomised comparison of the Fenix® magnetic anal sphincter versus sacral nerve stimulation for adult faecal incontinence
- A trial of percutaneous tibial nerve stimulation (PTNS) vs sham electrical stimulation (SES) in the treatment of faecal incontinence: CONtrol of Faecal Incontinence using Distal NeuromodulaTion (The CONFIDeNT Trial)
- Pathway Of Low Anterior Resection syndrome relief after Surgery (POLARiS) trial
Out of scope
Studies addressing questions of service delivery or implementation (including studies looking to provide evidence to improve the quality, accessibility, and organisation of services) may be more suited to the NIHR Health and Social Care Delivery Research (HSDR) programme.
Outputs
Pathways to Impact – we are focused on the impact of the research we fund. Applicants are asked to consider the timing and nature of deliverables in your proposals; and encouraged to maximise the impact of your research by explaining how you will mobilise knowledge and ensure that it is useful and relevant to stakeholders such as:
- policy makers
- public health officers
- special interest groups
- charities
- community audiences
- other stakeholders.
Duration and costs
You are advised that we are custodians of public funds and value for money is a key criteria that peer reviewers and funding committee members will assess applications against.
Eligibility
Please refer to the overview tab for the funding opportunity specific eligibility.
Inclusive research
You must detail how you have considered inclusive research design and sex and gender throughout the whole research lifecycle and provide information on any associated costs.
For full details see our inclusive research funding application guidance.
Visit funding web page
(https://www.nihr.ac.uk/funding/broad-call-interventions-improving-outcomes-adults-faecal-incontinence/2026477)
