Current and proposed trials in Pelvic Floor
NICE guidelines for FI Research
Current trials in pelvic floor
Pelvic Floor Clinical Studies Group RCOG
How does R&D prioritisation research submissions
NICE guidelines for FI Research
The NICE Guideline Development Group 2014 has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and care of people with faecal incontinence in the future.
Current trials supported by TPFS
1. Pelvic floor muscle training
What is the value of pelvic floor muscle training in preventing and treating obstetric-related faecal incontinence?
Obstetric-related faecal incontinence is a distressing condition which may occur early after childbirth. Previous obstetric injury is also a major cause of faecal incontinence in older women, so reducing risk would have important benefits for both young and old people. Obstetric risk factors relate not just to sphincter disruption, but also to pelvic floor damage, and there is reason to believe that improving pelvic and sphincter strength before potential injury may be beneficial. Equally, early intervention post partum may help reduce the well recognised risk of delayed-onset faecal incontinence in women.
There is no standardisation of what pelvic floor muscle training should comprise. There is also no evidence base on whether treatment before potential injury (that is, labour) serves a protective role. This study will require the interaction of obstetric, colorectal and physiotherapy services across primary and secondary care.
2. Patient-rated outcomes
The development of a valid and reliable tool to measure patient-rated outcomes including symptom severity and quality of life for people with faecal incontinence.
Research into and treatment of faecal incontinence is hampered by the lack of a valid and reliable tool that has been refined through iterative piloting and consultation stages. Such a tool would enable standardisation of outcome measures with which to compare results of interventions, allowing the effectiveness of interventions to be genuinely compared and accurately assessed.
Qualitative review for this guideline has highlighted the paucity of information on patients' views and the crudeness of current evaluation of symptoms and outcomes. By involving users, healthcare providers and qualitative researchers in the design of a tool, the most relevant outcomes (to all groups) could be measured, including symptom severity and quality of life. Each group would bring different perspectives to the tool, ensuring that all relevant topics are covered and that the tool is useful to all groups.
3. Self-care educational programmes
Would a self-care educational programme for patients and carers improve outcomes (symptom severity and quality of life) for people with faecal incontinence?
Qualitative evidence suggests that mutual support groups improve quality of life for people with faecal incontinence. Evidence also suggests that people with faecal incontinence should benefit from improved access to healthcare options, that information about management and treatment options is scarce, and that the taboo surrounding faecal incontinence hinders help-seeking behaviour. Addressing these issues would allow patients to be involved in tailoring of individual care plans.
A self-care group programme providing integrated education and support covering topics such as support networks, coping strategies, and identification and provision of suitable products and treatments may aid practical care and improve both physical and psychological outcomes. It would provide community-based healthcare, involving healthcare professionals including continence specialist clinicians and clinical psychologists, and would integrate with social care.
This type of self-care programme may reduce the demand on secondary care. The views of those attending may shape future health/social care by reducing the number of admissions to residential care because of faecal incontinence.
4. Bowel management programme
Does a bowel management programme for older people in care homes improve the outcomes of faecal incontinence and constipation? Does the programme improve perceptions of quality of care for the individual with faecal incontinence and the carer?
Over 50% of older people in care homes suffer from bowel-related problems. This is the cause of much anxiety and discomfort for patients, and adds to the carer burden. Moreover, with the UK's ageing population, this problem will increase with time. Little research has been done on effective bowel care in this population, and care is expensive, with laxatives, pads and carer time all contributing to the overall cost.
A management programme for this population may provide a way of enhancing the quality of life of people with faecal incontinence and their carers, and improve overall healthcare.
5. Specialist assessment
What is the prognostic value of physiological assessment in defining the outcome of surgery to treat faecal incontinence?
It is currently hard to predict which people will benefit from surgical treatment for faecal incontinence. Developing an improved selection procedure would reduce unnecessary procedures, reducing costs and improving care pathways for people with faecal incontinence.
Clinical assessment could be compared with full physiological and structural assessment in people referred for specialist assessment in whom surgery is contemplated. This would allow a more accurate correlative description of the relationship between symptoms and physiology or structure. This in turn would allow a better selection procedure to be developed. Following people through surgery and over a long-term follow-up period would allow the prognostic value of certain physiological/structural abnormalities in defining surgical outcome to be evaluated. Long-term outcome of certain surgical procedures could also be investigated.
This research question would be best answered by a multicentre study based on a network of NHS secondary care sites.
|CapaCITY||PI Prof CH Knowles||Protocol||
Trial starts 2015
|SaFaRI||PI Prof D Jayne||Protocol||Trial started 2015|
|HubBLE||PI Mr Steve Brown||Protocol||Trial started 2013||Abstract|
|CONFIDeNT||PI Prof CH Knowles||Trial completed 2014||Abstract|
|Geko||PI Miss Kathryn Gill||Trial completed 2012|
|eTHoS||PI prof Angus Watson||Trial completed||Paper|
|Effects of Botox on ODS||Massachusetts General Hospital Aug 2014|
The Pelvic Floor Clinical Studies Group
The Pelvic Floor Clinical Studies Group RCOG is an informal multi-disciplinary group of clinicians and academics chaired by Prof Doug Tincello. The Group has three main roles: to identify research priorities across the whole spectrum of pelvic floor disorders, and pass these to national funding bodies such as NIHR; to provide an early peer-review for investigators planning research applications in order to enhance the quality and likelihood of successful funding, and to develop research projects on a collaborative basis to address the identified research priorities. TPFS is represented on the group by Steve Brown and Andy Miller
The CSG can also provide applicant expertise in specific areas, and make contact on investigators’ behalf with patient groups or specific skill sets. An application proforma for peer review is available on their website
Anyone who is interested in contributing to the Group by offering peer review, or becoming a member, or suggesting research priorities should contact the CSG Chair,
How does the R&D committee prioritise research proposals
The R&D Committee is guided by the following principles:
The final proposals will represent current and timely priorities for pelvic floor health research
Each prioritised proposal must have a possibility of improving the health of patients receiving NHS care in the UK
The proposals must be feasible and represent good value for money for public investment in research
Where possible, there should be a spread of proposals representing the range of PF health issues
The R&D Committee uses these criteria to decide which proposals have high priority:
Importance of the condition (burden of disease)
If effective, number of cases prevented/severity decreased (duration of impact, impact on mortality/quality of life)
Importance of intervention
Potential impact of intervention
Substantial potential to improve health?
Realistic – how long until benefits could be realised?
Value for money?
Benefits in terms of reduced uncertainty
Outcomes for patients and carers
Outcomes for clinicians
Cost-effectiveness for the NHS
Other factors could include social or ethical concerns.