Topic: Primary Care, Gastroenterology
Conditions
Interventions
Participants are randomly allocated to one of three groups:
3-4 treatment sessions every 4 weeks (+/- 1 week)
Each session lasts 45-60min
1. Habit training (HT)
A written information leaflet coverin
causes of constipation
diet and fluid advice
getting into a good bowel habit, posture, defaecatory dynamics and pelvic floor exercises where relevant. Plenty of optimism, encouragement and personal attention.
2. Habit training with Biofeedback
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years 2. Patient self-reports problematic constipation 3. Symptom onset > 6 months prior to recruitment 4. Symptoms meet American College of Gastroenterology definition of constipation 5. Constipation failed treatment to a minimum basic standard (NHS Map of Medicine 2012 (lifestyle AND dietary measures AND =2 laxatives or prokinetics) tried (no time requirement) 6. Ability to understand written and spoken English (due to questionnaire validity) 7. Ability and willingness to give informed consent The study will use the American College of Gastroenterology definition of constipation (which is reasonable, simple and extensively published): unsatisfactory defaecation characterized by infrequent stool, difficult stool passage or both for at least previous 3 months. This avoids the more complex Rome definitions (which are likely to change with Rome IV in 2015).
Exclusion criteria
Exclusion criteria: The study interventions necessitate the exclusion of major causes of secondary constipation. In detail: 1. Significant organic colonic disease (red flag symptoms e.g. rectal bleeding prior investigated); IBD; megacolon or megarectum (if diagnosed beforehand) [the study will provide a useful estimate of the prevalence of such cases in referral practice]; severe diverticulosis/stricture/birth defects deemed to contribute to symptoms (incidental diverticulosis if known not an exclusion). 2. Major colorectal resectional surgery 3. Overt pelvic organ prolapse (bladder, uterus, rectum) or disease requiring obvious surgical intervention 4. Previous pelvic floor surgery to address defaecatory problems: posterior vaginal repair, STARR and rectopexy; previous sacral nerve stimulation 5. Rectal impaction (as defined by digital and abdominal examination: these form part of the NHS Map of Medicine basic standard) 6. Significant neurological disease deemed to be causative e.g. Parkinson’s, spinal injury, multiple sclerosis, diabetic neuropathy (not uncomplicated diabetes alone) 7. Significant connective tissue disease: scleroderma, systemic sclerosis and SLE (not hypermobility alone) 8. Significant medical comorbidities and activity of daily living impairment [based on Bartell index in apparently frail patients, Bartell index <=11] 9. Major active psychiatric diagnosis [schizophrenia, major depressive illness and mania] 10. Chronic regular opioid use (at least once daily use) where this is deemed to be the cause of constipation based on temporal association of symptoms with onset of therapy; all regular strong opioid use 11. Pregnancy or intention to become pregnant during study period 12. Previous nurse-led bowel management 13. Severe visual impairment sufficient to prevent visual biofeedback Urinary pregnancy testing will be made available to women of child-bearing potential at eligibility assessment and advice will be given to all women regarding need to prevent pregnancy during the study intervention period. Serum pregnancy testing will be mandatory for women of childbearing potential randomized to the INVEST group based on the NHS 10 day rule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to treatment defined as a 0.4 point [changed from 1-point on 10/05/2016] (or greater) reduction in PAC-QOL score at 6 months post end of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Added 10/05/2016: 1. Binary responses to treatment defined as either a 0.4-point (or greater) reduction in PAC-QOL score 2. Binary responses to treatment defined as either a 1-point (or greater) reduction in PAC-QOL score 3. PAC-QOL: individual domains and total score (as continuous variables) 4. PAC-SYM score: individual domains and total score (as continuous variables) 5. A two week patient diary (for 2 weeks prior to each assessment) to record bowel frequency and whether each evacuation was ‘spontaneous and / or complete’ 6. Journal will also capture concurrent medication, health contacts, time away from normal activities (including work) since the patient’s last visit 7. Generic QOL: EQ-5D-5L descriptive system and EQ-VAS 8. Patient Health Questionnaire-9 (PHQ-9) 9. Generalized anxiety disorder questionnaire (GAD7) 10. Global patient satisfaction / improvement score (VAS) and whether they would recommend each treatment experienced to other patients 11. Potentially modifiable cognitive and behavioural psychological variables shown to predict onset and perpetuation of other functional bowel symptoms: negative perfectionism, avoidant and ‘all or nothing’ behaviour subscales of the behavioural response to illness questionnaire (CC-BRQ), and Brief illness perception questionnaire BIPQ (CC) 12. Qualitative interviews to assess patient and researcher experience and acceptability of the interventions Measured at 3, 6, 12 months post end of treatment | — |
Countries
England, United Kingdom
Contacts
Public ContactShiva Taheri
Outcome results
None listed