Injectable synthetic calcium hydroxylapatite ceramic microspheres (Coaptite) for passive fecal incontinence

Abstract

Background: Passive fecal incontinence is a disabling condition caused by internal anal sphincter dysfunction. The aim of the study was to assess prospectively the effects of calcium hydroxylaptatite ceramic microspheres (Coaptite) as a bulking agents to treat patients with passive fecal incontinence.

Methods: Ten patients with passive fecal incontinence were recruited. All patients were assessed by clinical examination, anal ultrasonography and anal manometry. The severity of incontinence and quality of life were assessed using the Fecal Incontinence Scoring System (FISS) and Fecal Incontinence Quality of Life (FIQoL) questionnaire at baseline and at 3, 6 and 12 months after the Coaptite injection.

Results: Eight patients (80%) had a marked improvement in continence, with a significant reduction in FISS from 85.6+/-9.4 to 28.0+/-29.0 (p=0.008) at 12 months. There was an improvement in global quality of life scores, which was significant in three subscales (lifestyle, coping/behaviour and embarrassment). Manometry showed a significant improvement from baseline in the mean resting anal canal pressure after the Coaptite injection (p=0.018).

Conclusions: Coaptite is a promising and safe bulking agent for the treatment of passive fecal incontinence