Preliminary evaluation of an injectable anal sphincter bulking agent (Durasphere) in the management of faecal incontinence

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Abstract
Background : It has been previously shown that ‘bulking’ of internal anal sphincter defects may provide an effective method to treat patients with faecal incontinence, but the benefit wears off with time. Aim : To assess the efficacy of a larger molecule, bulking agent (Durasphere) over the short‐ and long‐term in patients with an internal anal sphincter defect refractory to conservative management. Patients : Eighteen patients (nine male, nine female) with a mean age of 60 years were recruited. All patients had persistent faecal leakage/soiling. Methods : Durasphere was injected in the submucosal plane to restore anal canal symmetry. All patients had anorectal physiology, endoanal ultrasound, continence grading, patient satisfaction and quality of life scores assessed at 1, 3, 6 and 12 months. Results : The mean follow‐up is 28.5 months. Changes from baseline were not statistically significant up to 6 months. At 12 months there was significant improvement in the continence grading (P = 0.003), patient satisfaction (P = 0.053) and all quality of life subscales: lifestyle (P = 0.004), coping (P = 0.011), depression (P = 0.024) and embarrassment (P = 0.059). Anorectal physiological parameters apart from the maximum tolerable rectal volume at 12 months (P = 0.036) showed no significant improvement. Conclusions : Anal sphincter bulking with Durasphere is safe and effective in the short term as well as the longer term. More importantly, there is no evidence of attenuation of effect over time.