Fecal Incontinence Clinical Trial
Official title:
Improving Continence in People With Inflammatory Bowel Disease: Active Case Finding and a Randomised Controlled Trial
Inflammatory Bowel Disease (IBD) affects 250,000 adults in the United Kingdom (UK) and causes
bouts of diarrhoea which are hard to control. Over a quarter of patients experience extremely
distressing faecal incontinence (FI). Even when the disease is in remission, the majority of
patients live in fear of not finding a toilet in time. This curtails their activities and
quality of life. The National Institute for Clinical Excellence (NICE 2007) has issued
national guidance on actively asking patients about FI and a step-wise care plan for managing
FI. However, this has not been evaluated in people with IBD, the vast majority of whom do not
ask for help, even when they have frequent FI.
Across six expert centres in the UK, the investigators will perform 3 linked studies: [1] The
investigators will screen people with IBD, offering the opportunity to obtain help with bowel
control. The investigators will compare uptake of a postal approach versus response to a
proactive face-to-face asking approach at a physical or telephone clinical appointment. [2]
The investigators will conduct a randomised controlled trial (RCT) comparing two different
approaches (IBD nurse specialist plus self-help booklet versus self-help booklet alone) to
see which one produces the best results in terms of reductions in FI, other symptoms, costs
and quality of life at 6 months after intervention. Booklet group participants may access the
nurse intervention at 6 months if they wish, when the RCT is finished. [3] Interviews will be
performed at the end of the intervention, gathering patient views and preferences and staff
perspectives via Qualitative interviews and free text questionnaire comments, to enable a
rich understanding and interpretation of our results.
The investigators will disseminate the results widely to people with IBD and health
professionals and take active steps to embed successful interventions in NHS services, having
gained sound evidence on how many people want help, whether intervention is effective in
improving FI, and patient and staff views on interventions.
Inflammatory bowel disease (IBD) affects approximately 250,000 UK adults. It causes symptoms
including diarrhoea and extreme faecal urgency and has an unpredictable relapsing-remitting
course. A quarter of people with IBD report faecal incontinence (FI) and two-thirds have
urgency, even when IBD is in remission. Although this limits peoples' lives, most do not seek
professional help. No study has determined whether nationally recommended approaches to FI
would help people with IBD.
Research question Does implementation of the nationally (NICE)-recommended approach to active
case-finding and step-wise management of FI improve bowel control and quality of life in
people with IBD.
The investigators will address 3 objectives:
1. To implement 'active case finding' for FI and life-restricting faecal urgency in people
with IBD, monitoring uptake of the offer of help and investigating barriers to accessing
care.
2. To determine the effectiveness of implementing the algorithm of care proposed by NICE
for people with FI in a randomised controlled trial compared to provision of the same
information in a self-management booklet. The trial will measure the effects of each
intervention at 6 months after completion of the intervention.
3. To obtain detailed qualitative feedback from patients and staff on the best way of
enabling health-seeking, the experience of the intervention and suggestions for future
service developments.
Plan of investigation We will conduct research in 6 UK specialist IBD services, in two phases
with an integral qualitative element.
Phase 1: active case finding: will (a) Compare active case finding rates of disclosure for FI
as recommended by NICE by using a postal, telephone or face to face approach; and (b)
Determine currently unmet need for intervention for FI. All hospitals will conduct postal
case-finding (1000 people) and all will conduct face to face or telephone questioning (1000
people) to compare numbers reporting FI and uptake of offer of intervention.
Phase 2: randomised controlled trial 186 patients with IBD and FI will be recruited (from
people wanting help in Phase 1) to a parallel multicentre RCT comparing 2 interventions: (a)
CONSULT + BOOKLET: 3-4 face to face or telephone consultations with an IBD specialist nurse
who has received extra training on FI plus provision of a booklet developed with IBD patients
on self-help for FI; (b) BOOKLET: intervention is booklet alone.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03825575 -
Sacral Neuromodulation as Treatment for Fecal Incontinence
|
N/A | |
Completed |
NCT00605826 -
A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence
|
N/A | |
Withdrawn |
NCT02208258 -
Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.
|
N/A | |
Completed |
NCT01957969 -
French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence
|
N/A | |
Completed |
NCT01939821 -
A Pilot Study to Evaluate Educational Programs to Improve Fecal Incontinence Care in Nursing Homes
|
N/A | |
Completed |
NCT01710579 -
Normal Values in Ano-rectal 3D High Resolution Manometry
|
N/A | |
Recruiting |
NCT00530933 -
Tibial Nerve Stimulation for Faecal Incontinence
|
N/A | |
Completed |
NCT00565136 -
Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms
|
Phase 1/Phase 2 | |
Withdrawn |
NCT00522691 -
Efficacy of Sacral Nerve Stimulation Before Definitive Implantation
|
N/A | |
Completed |
NCT00677508 -
Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling
|
||
Completed |
NCT05032534 -
Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence
|
N/A | |
Completed |
NCT05058326 -
Severity of Fecal Incontinence and Manometric Values Using the Anopress® Device in Women
|
||
Completed |
NCT03746834 -
NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation
|
Phase 4 | |
Completed |
NCT00124904 -
Biofeedback for Fecal Incontinence
|
N/A | |
Completed |
NCT03028636 -
LIBERATE - PRO: Eclipseâ„¢ System Registry
|
||
Completed |
NCT04097288 -
Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects
|
Phase 1 | |
Completed |
NCT05621629 -
Management of FI After Surgery of ARM
|
||
Withdrawn |
NCT04138602 -
BTL Emsella Chair Versus Sham for the Treatment of Fecal Incontinence
|
N/A | |
Completed |
NCT04478799 -
Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience
|
N/A | |
Completed |
NCT03252951 -
Physical Therapy for Anal Incontinence
|
N/A |