Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease

NCT03177044 | Completed DMC

• 1 other identifier: HREC/17/SVHM/92
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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..

Conditions

Inflammatory Bowel Diseases; Functional Gastrointestinal Disorders

Keywords

Inflammatory bowel disease, pelvic floor exercise

Outcome Measures

Primary Outcomes (1)

• Patient rating of improvement in symptoms

  Proportion of patients achieving a rating of 'moderately improved' or 'substantially improved' on a 7 point Likert scale ranging from 'substantially worse' to 'substantially improved'

  At study completion, up to 12 weeks

Secondary Outcomes (9)

• Change in Personal assessment of Constipation Symptoms (PAC-SYM) score

  From baseline to study completion (up to 12 weeks) and at 1 year

• Change in St Marks Faecal Incontinence Score

  From baseline to study completion (up to 12 weeks) and at 1 year

• Change in Inflammatory Bowel disease questionnaire (IBDQ) score

  From baseline to study completion (up to 12 weeks) and at 1 year

• Change in Short Form -36 (SF-36) score

  From baseline to study completion (up to 12 weeks) and at 1 year

• Change in Hospital Anxiety and Depression Score (HADS)

  From baseline to study completion (up to 12 weeks) and at 1 year

Other Outcomes (4)

• Change in Mayo Score

  From baseline to study completion (up to 12 weeks) and at 1 year

• Change in Harvey Bradshaw Index

  From baseline to study completion (up to 12 weeks) and at 1 year

• Patient rating of satisfaction

  At study completion , up to 12 weeks

Study Arms (1)

Behavioural treatment

EXPERIMENTAL

2 to 6 sessions of bowel behavioural training with a pelvic floor physiotherapist

Behavioral: Behavioural treatment

Interventions

Behavioural treatment BEHAVIORAL

2 to 6 sessions of behavioural training with a pelvic floor physiotherapist

Also known as: Behavioural training programme

Behavioural treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St Vincent's Hospital Melbourne: lead

Study Sites (1)

St Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Digestive System Diseases; Intestinal Diseases

Study Officials

• Michael A Kamm, MBBS PhD

  St Vincent's Hospital Melbourne

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All assessments are conducted by an assessor not providing the intervention
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective cohort

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 6, 2017
• Study Start: June 1, 2017
• Primary Completion: July 30, 2021
• Study Completion: December 31, 2021
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)