None listed
Conditions
Brief summary
Obstructive defaecation (OD) is a challenging clinical problem not uncommonly encountered in colorectal practice. OD is associated with depression, anxiety and impaired quality of life (QOL).1 Unfortunately, because the underlying anatomic and pathophysiology of OD is poorly understood, large number of medical, surgical and behavioural treatment have been described with no panacea. A recent meta-analysis suggests that biofeedback is effective in the treatment of OD, although only a handful of randomized trials, each with different biofeedback regime have been completed to date.2 Most trials have also focused on symptomatic improvement with relative neglect of impact of treatment on QOL or psychological state.2 In amongst the seemingly vast literature surrounding OD and its treatment, some fundamental questions remain unanswered: 1) is it the counselling and support that makes biofeedback effective; 2) is balloon retraining effective as a biofeedback modality; 3) does treatment improve QOL or psychological state. The biofeedback protocol at Royal Prince Alfred Hospital (RPAH) for OD is a comprehensive program entailing education, counselling (conservative management) and balloon retraining. Balloon retraining has only been evaluated in 1 randomised trial in 1995 (Koutsoumanis et al)3 and although improved treatment success have been noted since it was introduced at RPAH, whether or not this represents a biased observation remains unclear. A randomized controlled trial (RCT) is proposed to: 1) determine if biofeedback improves QOL and psychological state of patients with OD; 2) to determine if balloon retraining as a biofeedback modality is effective; 3) to determine if balloon retraining confers any additional benefit to patient receiving conservative management.
Interventions
Education sessions on the role of fluid, fibre, fitness and maintaining a correct posture during defecation plus a rectal balloon training.
For the rectal balloon trainig, the nurse will insert a deflated balloon into the rectum and inflate it with 50mL of warm water using a syringe. This provides the sensation of a full rectum and the need to defaecate. The biofeedback nurse will monitor your abdominal movements, relaxation and breathing during the attempt to expel the balloon and give you in
Education sessions on the role of fluid, fibre, fitness and maintaining a correct posture during defecation plus a rectal balloon training. For the rectal balloon trainig, the nurse will insert a deflated balloon into the rectum and inflate it with 50mL of warm water using a syringe. This provides the sensation of a full rectum and the need to defaecate. The biofeedback nurse will monitor your abdominal movements, relaxation and breathing during the attempt to expel the balloon and give you instant feedback on proper defecating technique. The biofeedback treatment will be facilitated by a specialised biofeedback nurse. Participants will received 1 hr sessions once a month for a total of 4 months.
Sponsors
A/Prof Christopher Young
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) prior assessment by a doctor, nurse specialist or physiotherapist; 2) fulfill the ROME criteria of obstructive defecation
Exclusion criteria
1) structural causes such as colorectal malignancy, full thickness rectal prolapse or a non-emptying rectocoele; 2) previous treatment with biofeedback; 3) poor command of English; 4) an underlying organic brain lesion that may limit a patient’s ability to understand or follow instructions for biofeedback; 5) unable to consent for other reasons.
Outcome results
None listed