A randomized controlled trial of four different regimes of biofeedback programme in the treatment of faecal incontinence.

Abstract

Biofeedback is an established, effective and non-invasive treatment for faecal incontinence (FI). The aim was to compare the effectiveness of four different biofeedback treatment regimes. This was a randomized control trial of patients with FI, stratified into two groups (metropolitan and rural) and then randomized into two subgroups (groups 1 and 2 within metropolitan, groups 3 and 4 within rural) with varying face-to-face and telephone biofeedback components. All patients received standardized counselling and education, dietary modification and the use of anti-diarrhoeal medications. Group 1 received four monthly face-to-face biofeedback treatments, groups 2 and 3 received one face-to-face biofeedback followed by telephone biofeedback and group 4 received a one-off face-to-face biofeedback treatment. Primary outcomes were patient-assessed severity of FI and quality of life as assessed by the 36-item Short Form Health Survey and direct questioning of objectives. Secondary outcomes included St Mark's incontinence score, anxiety, depression and anorectal physiology measures (resting, squeeze pressures; isotonic, isometric fatigue times). Between 2006 and 2012, 351 patients were recruited. One patient died leaving 350 for analysis. 332 (95%) were women. Mean age was 60 (SD=14). All groups had significant improvements in FI, quality of life, incontinence score and mental status (P<0.001 each). There were no differences in improvements in FI between groups although patient satisfaction was less with reduced face-to-face contact. There were modest improvements in isotonic and isometric fatigue times suggesting improved sphincter endurance (both P<0.001). Biofeedback is effective for FI. Although face-to-face and telephone biofeedback is not necessary to improve FI, it is important for patient satisfaction.