Clinical trial NCT03177044: Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease
Official title: Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Functional Gastrointestinal Disorders
Keywords: Inflammatory bowel disease, pelvic floor exercise
Lead sponsor: St Vincent's Hospital Melbourne
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort
Primary purpose: TREATMENT

Brief summary: The primary aim of the project is to investigate whether a behavioural training programme improves troublesome bowel symptoms, that people with inflammatory bowel disease continue to have, despite their disease being controlled by medication. The other aim is to determine if there are factors which influence how well the training programme works.

People attending an Inflammatory Bowel Disease clinic in a tertiary hospital, with bothersome bowel symptoms despite disease control, will be asked to join the study. This involves 2 to 6 sessions with a pelvic floor trained physiotherapist over a period of 6 months with further follow up at 12 months..

Detailed description: Inflammatory bowel diseases, chiefly Crohn's disease and ulcerative colitis, are chronic gastrointestinal (gut) conditions which tend to flare up some times and be quiet for other periods of time. They are usually controlled by medication. Inflammatory bowel disease is becoming more common, is usually diagnosed at a young age and is lifelong.

A significant number of people with inflammatory bowel disease can have bowel symptoms which are bothersome even when the disease is quiescent. These symptoms include bowel urgency, frequent toileting, incontinence (leakage), constipation (infrequent bowel actions and/or difficulty emptying the bowel), abdominal pain, rectal pain or abdominal bloating. The symptoms can be very embarrassing or stressful, limiting activities and making life less enjoyable.

People with these bowel symptoms, but without inflammatory bowel disease, respond to a type of therapy called behavioural treatment. We don't know yet if this treatment helps people with inflammatory bowel disease.

Behavioural treatment involves learning about how the bowel works, better ways to manage bowel problems and specific exercises to improve bowel control. Specially trained pelvic floor physiotherapists provide 2-6 sessions, over 6 months, of behavioural treatment which may include the use of biofeedback techniques.

Participants will be asked to complete surveys at the beginning and end of treatment and 12 months later.

There are no recognised risks or unwanted side effects caused by behavioural treatment. The benefits are that people with inflammatory bowel disease will have an alternative low cost, low risk treatment which enables them to self-manage bowel symptoms and improve the quality of their life long term.

Eligibility criteria: Inclusion Criteria:

* Proven history of inflammatory bowel disease
* Clinical evidence of mild, stable disease or remission
* Mayo score ≤ 4, Harvey Bradshaw index ≤ 7
* Bothersome lower bowel symptoms of any of the following: frequency, urgency, incontinence, difficult evacuation, constipation

Exclusion Criteria:

* Significant medical or psychiatric comorbidity that in the opinion of the investigators would interfere with bowel function or adherence to the protocol
* Clinically significant narcotic or substance abuse that in the opinion of the investigators would interfere with bowel function or adherence to the protocol
* Recognised eating disorder
* Non- English speaking or illiterate
* Pregnancy
* Previous pelvic floor physiotherapy
* Current participant in another trial

Primary outcomes:
measure: Patient rating of improvement in symptoms
timeFrame: At study completion, up to 12 weeks
Secondary outcomes:
measure: Change in Personal assessment of Constipation Symptoms (PAC-SYM) score
timeFrame: From baseline to study completion (up to 12 weeks) and at 1 year
measure: Change in St Marks Faecal Incontinence Score
timeFrame: From baseline to study completion (up to 12 weeks) and at 1 year
measure: Change in Inflammatory Bowel disease questionnaire (IBDQ) score
timeFrame: From baseline to study completion (up to 12 weeks) and at 1 year
measure: Change in Short Form -36 (SF-36) score
timeFrame: From baseline to study completion (up to 12 weeks) and at 1 year
measure: Change in Hospital Anxiety and Depression Score (HADS)
timeFrame: From baseline to study completion (up to 12 weeks) and at 1 year
measure: Change in Brief Illness Perception Questionnaire score
timeFrame: From baseline to study completion (up to 12 weeks) and at 1 year
measure: Change in Brief Cope score
timeFrame: From baseline to study completion (up to 12 weeks) and at 1 year
measure: Change in Inflammatory Bowel Disease Self-efficacy scale (IBD-SES)
timeFrame: From baseline to study completion (up to 12 weeks) and at 1 year
measure: Change in Euro-Qol (EQ-5D)
timeFrame: From baseline to study completion (up to 12 weeks) and at 1 year
Other outcomes:
measure: Change in Mayo Score
timeFrame: From baseline to study completion (up to 12 weeks) and at 1 year
measure: Change in Harvey Bradshaw Index
timeFrame: From baseline to study completion (up to 12 weeks) and at 1 year
measure: Patient rating of satisfaction
timeFrame: At study completion , up to 12 weeks
measure: Change in pelvic floor muscle function
timeFrame: From baseline to study completion (up to 12 weeks)
Locations:
city: Fitzroy
country: Australia
facility: St Vincent's Hospital
state: Victoria
Study officials:
affiliation: St Vincent's Hospital Melbourne
name: Michael A Kamm, MBBS PhD
role: STUDY_DIRECTOR
References: