Injectable collagen for the treatment of fecal incontinence: long-term results.

Maslekar, S; Smith, K; Harji, D; Griffiths, B; Sagar, P M

BACKGROUND Fecal incontinence is a distressing condition that is difficult to treat. Injection of bulking agents has been used to treat passive fecal incontinence. However, no long-term results are available. OBJECTIVE The aim of this study was to assess the long-term clinical effectiveness of intra-anal injection of collagen for passive fecal incontinence. DESIGN This research is a retrospective cohort study from a prospectively collected database SETTING This investigation took place in a high-volume tertiary colorectal department. PATIENTS All patients who underwent intra-anal injection of collagen for passive fecal incontinence with internal sphincter dysfunction between January 2006 and December 2009 were included in the study. Data including demographic details, preoperative anorectal physiology, and outcome measures were collected prospectively and maintained in a database MAIN OUTCOME MEASURES The primary outcomes measured were the Cleveland Clinic Florida incontinence score and the responses to a subjective patient satisfaction questionnaire before the procedure and at subsequent follow-up visits. Data were analyzed by using SPSS v19.0. RESULTS One hundred patients (70 female; mean age, 61 years (range, 36-82)) were followed up for a minimum duration of 36 months. Fifty-six patients (56%) had an improvement in fecal incontinence score from a mean of 14 (range, 9-18) to a mean of 8 (range, 5-14). A total of 68% reported subjective improvement in symptoms. Thirty-eight patients (38%) required a repeat injection of collagen, and a further 15 patients required a third injection. The median interval between the first and final injection was 12 months (range, 4-16 months). Age was the only independent predictor of successful outcome (p = 0.032). There was no morbidity. LIMITATIONS This study was limited by its nonrandomized retrospective design. CONCLUSIONS Injection of collagen into the internal anal sphincter is simple, safe, and effective in patients with passive fecal incontinence, although repeat injections are necessary in approximately half of the patients.