Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: study protocol for a randomised controlled trial.
Constipation affects up to 20% of adults. Chronic constipation (CC) affects 1-2% of adults. Patient dissatisfaction is high; nearly 80% feel that laxative therapy is unsatisfactory and symptoms have significant impact on quality of life. There is uncertainty about the value of specialist investigations and whether equipment-intensive therapies using biofeedback confer additional benefit when compared with specialist conservative advice.



A three-arm, parallel-group, multicentre randomised controlled trial.



to determine whether standardised specialist-led habit training plus pelvic floor retraining using computerised biofeedback is more clinically effective than standardised specialist-led habit training alone; to determine whether outcomes are improved by stratification based on prior investigation of anorectal and colonic pathophysiology. Primary outcome measure is response to treatment, defined as a 0.4-point (10% of scale) or greater reduction in Patient Assessment of Constipation-Quality of Life (PAC-QOL) score 6 months after the end of treatment. Other outcomes up to 12 months include symptoms, quality of life, health economics, psychological health and qualitative experience.



(1) habit training (HT) with computer-assisted direct visual biofeedback (HTBF) results in an average reduction in PAC-QOL score of 0.4 points at 6 months compared to HT alone in unselected adults with CC, (2) stratification to either HT or HTBF informed by pathophysiological investigation (INVEST) results in an average 0.4-point reduction in PAC-QOL score at 6 months compared with treatment not directed by investigations (No-INVEST). Inclusion: chronic constipation in adults (aged 18-70 years) defined by self-reported symptom duration of more than 6 months; failure of previous laxatives or prokinetics and diet and lifestyle modifications. Consenting participants (n = 394) will be randomised to one of three arms in an allocation ratio of 3:3:2: [1] habit training, [2] habit training and biofeedback or [3] investigation-led allocation to one of these arms. Analysis will be on an intention-to-treat basis.



This trial has the potential to answer some of the major outstanding questions in the management of chronic constipation, including whether costly invasive tests are warranted and whether computer-assisted direct visual biofeedback confers additional benefit to well-managed specialist advice alone.



International Standard Randomised Controlled Trial Number: ISRCTN11791740. Registered on 16 July 2015.
King's College, 57 Waterloo Road, London, SE1 8WA, UK. Christine.norton@kcl.ac.uk.
Christine
0000-0003-2259-0948
C
Norton
University College Hospital, 235 Euston Road, London, NW1 2BU, UK.
Anton
A
Emmanuel
Blizard Institute, Queen Mary University of London, 2 Newark Street, London, E1 2AT, UK.
Natasha
N
Stevens
Blizard Institute, Queen Mary University of London, 2 Newark Street, London, E1 2AT, UK.
S Mark
SM
Scott
Blizard Institute, Queen Mary University of London, 2 Newark Street, London, E1 2AT, UK.
Ugo
U
Grossi
Blizard Institute, Queen Mary University of London, 2 Newark Street, London, E1 2AT, UK.
Sybil
S
Bannister
Blizard Institute, Queen Mary University of London, 4 Newark Street, London, E1 2AT, UK.
Sandra
S
Eldridge
Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
James M
JM
Mason
Blizard Institute, Queen Mary University of London, 2 Newark Street, London, E1 2AT, UK.
Charles H
CH
Knowles
D000293:Adolescent; D000328:Adult; D000368:Aged; D001003:Anal Canal / Q000503:physiopathology*; D001676:Biofeedback, Psychology / Q000379:methods*; D002908:Chronic Disease; D002985:Clinical Protocols; D003106:Colon / Q000503:physiopathology*; D003196:Computer Graphics; D003248:Constipation / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D003672:Defecation; D005260:Female; D006184:Habits; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008365:Manometry; D008875:Middle Aged; D017060:Patient Satisfaction; D017773:Pelvic Floor / Q000503:physiopathology*; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D011795:Surveys and Questionnaires; D013813:Therapy, Computer-Assisted / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D014796:Visual Perception; D055815:Young Adult
Anorectal testing; Behavioural intervention; Biofeedback; Constipation; Randomised controlled trial